Side effects, antibodies, cost, and more

Remicade is a brand-name prescription medication. It’s FDA-approved to treat certain autoimmune diseases in adults and children. These are conditions in which your immune system mistakenly attacks your body’s own tissues or organs. Conditions that Remicade is used to treat are:

Remicade is a treatment option for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, the drug is usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Remicade drug class and form

Remicade contains the drug infliximab, which is a biologic (a drug made from parts of living organisms). Remicade belongs to a drug class called tumor necrosis factor-alpha (TNF-alpha) blockers. A class of drugs is a group of medications that work in a similar way.

Remicade comes as a vial of powder that’s mixed with a liquid solution. The drug is available in one strength: 100 mg.

A healthcare provider will give you Remicade as an infusion. This is an injection into your vein that’s given over a period of time. Remicade infusions are typically about 2 hours long. You’ll usually receive an infusion every few weeks, but the timing depends on the condition that’s being treated.

Effectiveness

For information on the effectiveness of Remicade, please see the “Remicade uses” section below.

Remicade is available only as a brand-name medication. It contains the active drug ingredient infliximab.

The Food and Drug Administration (FDA) has approved four biosimilar versions of Remicade: Avsola, Inflectra, Ixifi, and Renflexis.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

Remicade can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Remicade. These lists don’t include all possible side effects.

For more information on the possible side effects of Remicade, talk with your doctor or pharmacist. They can also give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Remicade, you can do so through MedWatch.

More common side effects

The more common side effects of Remicade can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Remicade aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• New or worsening heart failure. Symptoms can include:
  • edema (swelling, typically in your ankles and feet)
• Heart attack. Symptoms can include:
  • lightheadedness or fainting
• Abnormal heart rhythms. Symptoms can include:
• Stroke. Symptoms can include:
  • weakness on one side of the body
  • trouble speaking or understanding others
  • trouble seeing in one or both of the eyes
  • trouble standing or walking
• Liver problems. Symptoms can include:
  • jaundice (yellowing of your skin and the white of your eyes)
  • pain on the right side of your belly
• Blood disorders, such as a low level of white blood cells. Symptoms can include:
  • bruising or bleeding easily
  • fever that lasts longer than 48 hours
• Nervous system disorders, such as seizures or vision problems. Symptoms can include:
  • numbness or tingling of body parts
  • weakness in your arms or legs
  • vision loss or changes in how you see color
• New or worsening psoriasis (a condition in which itchy, red patches form on your skin). Symptoms include:
  • scaly, red patches on skin
  • raised bumps on skin that are filled with pus
• Infusion reactions (symptoms or side effects that typically occur within 2 hours of your infusion). Symptoms can include:
  • chills (feeling cold for no reason)
• Certain cancers,* such as lymphomas (cancers of the lymphatic system). Symptoms can include:

Other serious side effects, explained in more detail below in “Side effect details,” include:

* Remicade has boxed warnings for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Side effects in children

In clinical studies, children with Crohn’s disease or ulcerative colitis had certain side effects more often than adults.

Side effects that occurred more often in children were:

• anemia (low level of red blood cells)
• low level of white blood cells
• flushing (warmth and redness in the skin)
• bacterial and viral infections
• bone fractures
• allergic reactions of the throat and lungs

Your doctor will monitor your child for these side effects during and after Remicade treatment.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, you may have an allergic reaction after taking Remicade. In clinical studies of people who took Remicade to treat rheumatoid arthritis (RA), at least 0. 2% had an allergic reaction. Remicade wasn’t compared with a different drug or a placebo (treatment with no active drug.

In a study of children with Crohn’s disease, 6% of those who took Remicade had an allergic reaction that affected their lungs. Remicade wasn’t compared with a different drug or a placebo.

And in a study of adults with plaque psoriasis, 1% of people who took Remicade had a possible allergic reaction that occurred within 2 weeks after the infusion. Again, Remicade wasn’t compared with a different drug or a placebo.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

It’s also possible to have an allergic reaction after taking Remicade for a while. Or you may have an allergic reaction if you receive a Remicade infusion after a break in treatment. In addition to the usual allergic reaction symptoms, you may have:

• fever
• headache
• sore throat
• muscle and joint pain

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Remicade. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Long-term side effects

Side effects can occur if Remicade is taken over a long period time of time. These long-term side effects are similar to those seen in clinical studies.

In one long-term study, 23.3% of people who took Remicade had long-term side effects. This was compared with 11% of people who took a different TNF inhibitor. However, long-term side effects may vary depending on what condition you’re using the drug to treat and what other medications you’re taking with Remicade.

Safety concerns with long-term Remicade use include:

• increased risk of infections, such as TB or hepatitis B
• new or worsening heart failure or other heart problems, such as heart attack
• blood disorders, such as a low level of white blood cells
• liver problems, which can lead to jaundice
• nervous system disorders, such as seizures
• lupus-like syndrome (an immune system reaction)
• increased risk of certain cancers, such as lymphomas (cancers in the lymphatic system)

Some people treated with Remicade develop antibodies to the drug. These antibodies are immune system proteins that mistakenly attack the drug. If this occurs, Remicade may no longer work for you.

If you’re concerned about possible long-term side effects of Remicade, talk with your doctor.

Headache

Headache was one of the most common side effects seen in Remicade clinical studies. For example, 18% of people with RA who received Remicade had headaches. This was compared with 14% of people who took a placebo. Rates of headache may vary depending on what condition you’re using Remicade to treat.

Headache may also be a symptom of infusion reactions. These are symptoms or side effects that occur during or shortly after an infusion. Infusion reactions were one of the most common reasons that people stopped taking Remicade.

A headache may also be part of a delayed allergic reaction. This occurs several hours to days after an infusion.

A severe headache could be a sign of something more serious, such as a stroke. Other signs of a stroke include trouble walking or speaking, dizziness, or confusion.

If you have a headache that’s very painful or doesn’t improve with medication, call your doctor right away. If you feel like you’re having a medical emergency, call 911.

Rash

In a clinical study of people with RA, 10% of those who took Remicade had rashes. In comparison, rash occurred in 5% of people who took a placebo. Rates of rash may vary depending on what condition you’re using Remicade to treat.

Rash is also a symptom of infusion reactions. These are side effects or symptoms that occur during or shortly after an infusion.

In addition, rash is a common symptom of lupus-like syndrome, an immune system reaction that can occur during Remicade treatment.

If you develop a rash while taking Remicade, talk with your doctor about possible remedies. If the rash is mild, they may recommend topical medication (treatment applied to the skin). If the rash is more serious, they may want you to stop taking Remicade and switch to a different drug.

Fatigue

In clinical studies, 9% of people with RA who took Remicade had fatigue (lack of energy). In comparison, 7% of people who took a placebo had fatigue. Rates of fatigue may vary depending on what condition you’re using Remicade to treat.

Fatigue can also be a symptom of more serious Remicade side effects, such as infections or liver problems.

In addition, fatigue is a common symptom of many autoimmune diseases (conditions in which your immune system attacks your body by mistake). Fatigue may be caused by:

• inflammation (swelling)
• stress
• lack of sleep
• pain
• other factors

If fatigue is harming your quality of life while you take Remicade, talk with your doctor. They can suggest ways to boost your energy levels.

Joint pain

In clinical studies, 8% of people with RA who took Remicade had joint pain.

Joint pain was also a side effect of delayed reactions, along with muscle pain, fever, and rash.

In addition, joint pain was reported in people whose tuberculosis (TB) or hepatitis B reactivated (came back) or who developed a new case of lupus-like syndrome (an immune system reaction).

Remicade is used to treat conditions that have symptoms such as joint pain. So it may be hard to determine whether Remicade or the disease is causing the joint pain.

If you have new or worsening joint pain, talk with your doctor. They’ll check to see if there are other conditions that may be causing the pain. Your doctor can also recommend pain medication to help ease your discomfort.

Lupus

Lupus-like syndrome (an immune system reaction) has been reported in clinical studies of Remicade. Symptoms include:

• shortness of breath
• chest pain or discomfort
• joint pain
• rashes on arms or cheeks, which tend to get worse in sunlight

Some people have also had fever, weight loss, and malaise (feeling weak, tired, and simply not well). Rare but serious symptoms of lupus-like syndrome can include lung inflammation (swelling), nerve problems, and blood clots. Symptoms can occur within months to years of starting Remicade use.

It’s thought that Remicade causes a lupus-like syndrome because of the development of autoantibodies following treatment. Autoantibodies are immune system proteins made in your body. They mistakenly attack your own tissues or organs.

If you have lupus-like syndrome, your doctor may recommend that you stop taking Remicade. Symptoms usually go away within weeks to months after ending Remicade treatment.

Cancer/lymphoma

New cases of cancers* were reported in people who took Remicade in clinical trials and in people taking the drug after it was made available to the public. Cancer cases were also reported in people who took other drugs in the tumor necrosis factor-alpha (TNF-alpha) blocker class. This is the drug class that Remicade is in.

However, it’s not clear whether Remicade causes cancer.

Types of cancer

About half of the cancers were lymphomas (cancers in the lymphatic system). Cells in the lymph system usually fight off infections, but they can become cancerous. Types of lymphatic system cancers include Hodgkin lymphoma and non-Hodgkin lymphoma.

Other types of cancers reported were skin cancer, cervical cancer, breast cancer, colorectal cancer, and the rare hepatosplenic T-cell lymphoma.

People with chronic obstructive pulmonary disease (COPD) also had new cases of lung cancer, or head or neck cancer. Many cases of cancer occurred in children, teenagers, and young adults. Most of the new cancer cases occurred in people who were taking additional drugs that weakened their immune system.

The following people may be at greater risk for developing cancer when taking Remicade:

• those with COPD
• women older than age 60 years who have RA
• those with Crohn’s disease or ulcerative colitis and who are taking a TNF-alpha blocker as well as azathioprine or methotrexate
• those who have a very active autoimmune disease (a condition in which your immune system attacks your body by mistake) and have been treated for a long time

Statistics

In clinical trials of various conditions,** new lymphoma cancers occurred at a rate of 1 case for every 1,000 people who took Remicade for a year. This rate is about four times higher than is seen in the general population.

In clinical trials of various conditions,** new cases of cancer (excluding lymphoma and skin cancer) occurred at a rate of about 5 cases for every 1,000 people who took Remicade for a year. This rate is similar to what’s expected in the general population.

Remicade risk

Again, we don’t know whether Remicade actually causes cancer. A review of multiple studies found that the evidence of cancer risk was conflicting. Analyses of studies and registries that collect information from larger populations also have conflicting results.

If you have concerns about cancer, talk with your doctor about your medical history and your risk for cancer. They’ll explain the benefits and risks of taking Remicade.

* Remicade has a boxed warning for cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

** Rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis

Serious infections

Remicade can increase the risk of serious infections.* These infections include tuberculosis (TB), hepatitis B, fungal infections throughout the body, and other bacterial and viral infections.

In clinical trials of Remicade, 36% of people who took Remicade received treatment for an infection. This was compared with 25% of people who took a placebo. It’s not known how many people had an infection but didn’t receive treatment for it.

Serious infections occurred at lower rates, however. For example, in clinical studies of RA, 5.3% of people who took Remicade had a serious infection. This was compared to 3.4% of people who took a placebo. Both groups also took methotrexate.

In one clinical study of children with ulcerative colitis, 12% of those who took Remicade had a serious infection. Remicade wasn’t compared with a different drug or a placebo.

Symptoms of serious infections

Symptoms of serious infections can include:

• cough
• fever
• tiredness
• lack of appetite
• rash
• flu-like symptoms (such as a runny nose, chills, and muscle aches)

Your doctor will monitor you closely for symptoms of infection during and after Remicade treatment. You may need to be treated for an infection before you start to take Remicade. This is for cases in which you have an infection but don’t have symptoms yet.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Weight gain

Weight gain wasn’t a side effect reported in the initial clinical studies of Remicade.

However, it has been seen in some other studies:

• A small survey was conducted in people with various conditions who took tumor necrosis factor-alpha (TNF-alpha) drugs. This is the drug class that includes Remicade. (A drug class is a group of medications that work in a similar way.) The survey found that 13.3% of the people gained weight. The average weight gain was about 12 pounds (5.5 kilograms).
• In another small study, 68% of people with Crohn’s disease gained weight after taking Remicade for a year. Remicade wasn’t compared with a different drug or a placebo.
• And in a different small study of people with psoriasis, those treated with Remicade gained about 6 pounds (2.9 kilograms) on average. In comparison, no weight gain was reported in people who took the psoriasis drugs ustekinumab or secukinumab.

Very sudden weight gain may also be a sign of new or worsening heart failure.

If you’re concerned about weight gain, talk with your doctor about possible causes. They can suggest ways you can manage your weight.

Depression (not a side effect)

Depression wasn’t reported as a side effect in Remicade clinical studies. However, many people who have an autoimmune disease (a condition in which your immune system attacks your body by mistake) do have depression because of their disease. This depression may be caused by:

• inflammation (swelling)
• pain
• stress
• lack of sleep
• other factors

In clinical studies of people with inflammation conditions, such as psoriasis or Crohn’s disease, Remicade was found to be significantly more effective for easing depressive symptoms than a placebo. It’s not clear why, but a reduction in inflammation may have played a role.

If you think you might have depression, talk with your doctor. They can recommend treatments to help ease your symptoms.

Hair loss (not a side effect)

Hair loss wasn’t a side effect reported in clinical trials of Remicade.

In one study, about 3% of people had hair loss while taking tumor necrosis factor-alpha (TNF-alpha) medications. These drugs are in the same class as Remicade. (A drug class is a group of medications that work in a similar way.) The TNF-alpha drugs weren’t compared with a different drug or a placebo.

In another study, people who took Remicade had new or worsening cases of psoriasis. Symptoms can include itchy rashes or plaques (red, inflamed patches) on the scalp. These can lead to hair loss in that area. Plaques can also form on the arms or legs, which can lead to hair loss there, too.

It’s not known why Remicade causes psoriasis in some people because the Food and Drug Administration (FDA) has approved the drug to actually treat psoriasis.

In some cases, people’s hair started growing again after they stopped taking Remicade.

If your doctor wants you to keep using Remicade, topical treatments may help lessen hair loss due to psoriasis. (Topical treatments are applied to the skin. ) If you have any concerns about hair loss, talk with your doctor.

Effects on teeth (not a side effect)

In clinical studies, people who took Remicade didn’t have any side effects related to teeth.

However, people taking Remicade are at an increased risk of infections. These can include infections that may occur following dental procedures.

If you’re taking Remicade, talk with your doctor and dentist. They can advise you on how to keep your mouth healthy and help prevent infections related to dental procedures.

Some people’s immune systems will develop antidrug antibodies to Remicade. Antibodies are immune system proteins that the body develops in response to foreign substances. Antibodies to Remicade will mistakenly attack the drug and clear it from your body more quickly.

Developing antibodies to Remicade can cause the drug to be less effective for you. It may also increase your risk of having a reaction to Remicade infusions. If you have a reaction, your doctor may recommend switching to a different medication.

In one study, researchers reviewed several clinical trials. They found that people who took Remicade had one of the highest rates of antidrug antibody formation. This was compared with people who took other biologic drugs for their conditions. (A biologic is made from parts of living organisms.)

If you’re taking higher doses of Remicade or taking Remicade with other drugs, you’re more likely to develop antibodies to Remicade.

If you have any questions about antibodies and Remicade, talk with your doctor.

As with all medications, the cost of Remicade can vary.

The actual price you’ll pay depends on your insurance coverage and your location.

Your insurance plan may require you to get prior authorization before approving coverage for Remicade. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Remicade.

If you’re not sure if you’ll need to get prior authorization for Remicade, contact your insurance company.

Financial assistance

If you need financial support to pay for Remicade, help is available. Janssen, the manufacturer of Remicade, offers a program called Janssen CarePath. For more information and to find out if you’re eligible for support, call 877-CarePath (877-227-3728) or visit the program website.

The Remicade dosage that your doctor prescribes will depend on several factors. These include:

• the condition you’re using Remicade to treat
• how much you weigh
• how well your body responds to Remicade treatment

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Remicade comes as a vial of powder, and each vial contains 100 mg of infliximab (the active drug in Remicade). Your healthcare provider will add a liquid to the vial to make a solution.

Then the healthcare provider will give you the Remicade solution as an infusion. This is an injection into your vein that’s given over a period of time.

Remicade infusions are typically about 2 hours long.

Dosage for FDA-approved indications

Your Remicade dosage will be based on your weight and the condition you’re taking Remicade for.

Remicade is given in two stages: an induction (beginning) stage and a maintenance stage.

In the induction stage, you’ll receive Remicade infusions at week 0, week 2, and week 6. After the induction stage, you’ll receive maintenance infusions every 6 or 8 weeks.

You may need higher doses or more frequent doses to help control your condition.

Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis

Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis have the same recommended dosing for adults. You’ll receive induction infusions of 5 mg/kg (5 mg/2.2 lb) at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 5 mg/kg every 8 weeks thereafter.

Here’s an example of how Remicade dosages are usually calculated: A 176-pound (80-kg) man taking Remicade for Crohn’s disease would receive a dose of about 400 mg in each infusion.

Rheumatoid arthritis

For rheumatoid arthritis (RA) in adults, the recommended dosing is induction infusions of 3 mg/kg (3 mg/2.2 lb) at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 3 mg/kg every 8 weeks thereafter.

Ankylosing spondylitis

For ankylosing spondylitis in adults, the recommended dosing is induction infusions of 5 mg/kg (5 mg/2.2 lb) at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 5 mg/kg every 6 weeks thereafter.

Pediatric dosage

The Food and Drug Administration (FDA) has approved Remicade to treat children with Crohn’s disease or ulcerative colitis.

The dosage for children is the same as for adults. The induction (beginning) stage of dosing is 5 mg/kg (5 mg/2. 2 lb) at weeks 0, 2, and 6. That’s followed by maintenance dosing of 5 mg/kg every 8 weeks.

What if I miss a dose?

It’s important to attend all your infusion visits. This gives you the best chance of improving your condition. If you regularly miss infusion appointments, your condition may worsen.

If you can’t make an appointment or forget to go, call your doctor’s office right away. The staff can reschedule your infusion. They may adjust the timing of your next visit based on when you had your most recent infusion.

When you make an appointment, write it down on a calendar. Or put a reminder on your phone so you can stay on track with your infusions.

Will I need to use this drug long term?

Remicade is meant to be used as a long-term treatment. If you and your doctor determine that Remicade is safe and effective for you, you’ll likely take it long term.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Remicade, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for moderate to severe Crohn’s disease

According to treatment guidelines, other drugs that may be used to treat Crohn’s disease include:

• oral corticosteroids, such as prednisone
• azathioprine (Azasan, Imuran)
• 6-mercaptopurine (Purinethol, Purixan)
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
• vedolizumab (Entyvio)
• natalizumab (Tysabri)
• ustekinumab (Stelara)

Alternatives for ulcerative colitis

According to treatment guidelines, other drugs that may be used to treat ulcerative colitis include:

• oral corticosteroids, such as prednisone

• mesalamine (Apriso, Asacol HD, Canasa, SfRowasa)
• balsalazide (Colazal, Giazo)
• olsalazine (Dipentum)
• rectal hydrocortisone (Cortifoam)
• azathioprine (Azasan, Imuran)
• 6-mercaptopurine (Purinethol, Purixan)

Alternatives for rheumatoid arthritis

According to treatment guidelines, other drugs that may be used to treat rheumatoid arthritis include:

• oral corticosteroids, such as prednisone
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• sulfasalazine (Azulfidine)
• hydroxychloroquine (Plaquenil)
• leflunomide (Arava)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
• golimumab (Simponi)
• certolizumab pegol (Cimzia)
• etanercept (Enbrel, Erelzi)
• abatacept (Orencia)
• tocilizumab (Actemra)

Alternatives for ankylosing spondylitis

According to treatment guidelines, other drugs may be used to treat ankylosing spondylitis. Some of these drugs are:

Alternatives for psoriatic arthritis

According to treatment guidelines, other drugs that may be used to psoriatic arthritis are:

• NSAIDS, such as naproxen (Aleve, Naprosyn) and celecoxib (Celebrex)
• oral or injectable corticosteroids, such as prednisone, methylprednisolone (Depo-Medrol, Medrol), hydrocortisone (Solu-Cortef)
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• sulfasalazine (Azulfidine)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
• golimumab (Simponi)
• certolizumab pegol (Cimzia)
• etanercept (Enbrel, Erelzi)
• ustekinumab (Stelara)
• secukinumab (Cosentyx)
• abatacept (Orencia)

Alternatives for plaque psoriasis

According to treatment guidelines, other drugs that may be used to treat plaque psoriasis include:

• topical (treatment applied to the skin) corticosteroids
• topical vitamin D analogues, such as calcipotriene (Dovonex, Enstilar, Sorilux), calcitriol (Vectical)
• topical retinoids, such as tazarotene (Tazorac)
• topical coal tar
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• etanercept (Enbrel, Erelzi)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)

You may wonder how Remicade compares with other medications that are prescribed for similar uses. Here we look at how Remicade and Humira are alike and different.

Ingredients

Remicade contains the drug infliximab. Humira contains the drug adalimumab.

Uses

The Food and Drug Administration (FDA) has approved both Remicade and Humira to treat the following conditions:

Humira is also FDA-approved to treat:

Remicade and Humira are considered treatment options for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, the drugs are usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Drug forms and administration

Remicade comes as a vial of powder. Your healthcare provider will mix it with a liquid to make a solution. They will then give you the Remicade solution as an infusion. This is an injection into your vein that’s given over a period of time.

You’ll go to your doctor’s office or a clinic to have the infusions. Remicade infusions are typically around 2 hours long. The usual dosing schedule is once every 8 weeks after you complete the first stage of dosing.

Humira comes in three forms:

• a prefilled, single-dose syringe
• a prefilled, single-dose pen
• a single-dose vial for use only by a healthcare provider

Humira is given as an injection just under your skin (subcutaneous). A healthcare provider can give you the injections, or you can inject yourself at home. The usual dosing schedule is one injection every other week.

Side effects and risks

Remicade and Humira work in different ways but have some similar side effects. Examples of common and serious side effects for each drug are listed below.

People in both Remicade clinical studies and Humira clinical studies had side effects. But these may be symptoms of other side effects. For example, a fever may be a symptom of an infection. Side effects may overlap between the drugs.

More common side effects

Here are examples of more common side effects that can occur with Remicade, with Humira, or with both drugs (when taken individually).

• Can occur with Remicade:
• Can occur with Humira:
  • injection site reactions (redness, swelling, or pain where you had the injection)
  • rash
• Can occur with both Remicade and Humira:

Serious side effects

Here are examples of serious side effects that can occur with Remicade, with Humira, or with both drugs (when taken individually).

• Can occur with Remicade:
  • infusion reactions (side effects or symptoms that occur during or shortly after an infusion), such as rash
• Can occur with Humira:
  • few unique serious side effects
• Can occur with both Remicade and Humira:

* Remicade and Humira have boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information about Remicade’s boxed warnings, see “FDA warnings” at the beginning of this article.

Effectiveness

Remicade and Humira have different FDA-approved uses. But they’re both used to treat the following conditions:

• Crohn’s disease
• ulcerative colitis
• rheumatoid arthritis
• ankylosing spondylitis
• psoriatic arthritis
• plaque psoriasis

These drugs haven’t been directly compared in clinical studies, but studies have found both Remicade and Humira to be effective for treating the conditions mentioned above.

Costs

Remicade and Humira are both brand-name drugs. Biosimilars of both Remicade and Humira are FDA-approved.

• Remicade’s biosimilars are Inflectra, Ixifi, Avsola, and Renflexis.
• Humira’s biosimilars are Hadlima, Cyltezo, Hyrimoz, Abrilada, and Amjevita.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

The cost of Remicade and Humira depends on many factors, including the form used, the dosage, and the length of treatment. To learn more about cost for both drugs, visit GoodRx.

Like Humira (above), the drug Inflectra (infliximab-dyyb) has uses similar to those of Remicade. Here’s a comparison of how Remicade and Inflectra are alike and different.

Ingredients

Remicade contains the drug infliximab.

Inflectra contains infliximab-dyyb, a biosimilar of infliximab.

Biosimilars are biologic drugs made from living organisms. They are very similar to another medication (a reference drug) approved by the Food and Drug Administration (FDA).

Remicade is the reference drug for Inflectra. The “-dyyb” ending is added to the drug name to show that Remicade and Inflectra are two different products.

The FDA has reviewed how safe and effective biosimilars and their reference drugs are. The two medications act in very similar ways in the body. There aren’t any major differences in how they work. So the information for Remicade and its biosimilar Inflectra is alike.

Uses

Remicade and Inflectra are FDA-approved to treat people with the following conditions:

Remicade and Inflectra are considered treatment options for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, these drugs are usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Drug forms and administration

Remicade and Inflectra both come as a vial of powder. Your healthcare provider will mix it with a liquid to make a solution.

Both drugs are given as an infusion. This is an injection into your vein that’s given over a period of time.

You’ll go to your doctor’s office or a clinic to have the infusions. Remicade and Inflectra infusions are usually about 2 hours long. The usual dosing schedule is once every 8 weeks after you complete the first stage of dosing.

Side effects and risks

Because Inflectra is a biosimilar of infliximab (the active drug in Remicade), Inflectra and Remicade have the same side effects. Examples of common and serious side effects for each drug are listed below.

More common side effects

This list contains more common side effects that can occur with both Remicade and Inflectra (when taken individually):

Serious side effects

Here are examples of serious side effects that can occur with Remicade and Inflectra (when taken individually):

* Remicade and Inflectra have boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information about Remicade’s boxed warnings, see “FDA warnings” at the beginning of this article.

Effectiveness

Remicade and Inflectra have the same FDA-approved uses.

The FDA has reviewed how safe and effective Remicade biosimilars, such as Inflectra, are. Remicade and Inflectra act in very similar ways in the body. There aren’t any major differences in how they work.

A clinical study looked at people with Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, or plaque psoriasis. The people either switched from Remicade to Inflectra or kept taking Remicade. Inflectra helped control symptoms about as well Remicade.

A review article that included several clinical studies also found that switching from Remicade to biosimilars (such as Inflectra) provided similar symptom control.

However, current evidence of the long-term effectiveness of Remicade compared with its biosimilars is limited.

Costs

Remicade and Inflectra are both brand-name drugs. Remicade has four biosimilars: Avsola, Inflectra, Ixifi, and Renflexis. Inflectra is a biosimilar of Remicade.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

According to estimates on GoodRx.com, Remicade generally costs more than Inflectra per vial. The actual price you’ll pay for either drug depends on your dose, your location, and your insurance plan.

The Food and Drug Administration (FDA) approves prescription drugs such as Remicade to treat certain conditions. Remicade may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Approved uses for Remicade

Remicade is approved by the FDA to treat several autoimmune diseases (conditions in which your immune system attacks your body by mistake).

Remicade for Crohn’s disease

Crohn’s disease is a kind of inflammatory bowel disease (IBD) in which you have inflammation (swelling) in your digestive tract.

Remicade is FDA-approved to treat moderate to severe Crohn’s disease in adults as well as children ages 6 years and older. It’s approved for use when other commonly used medications haven’t eased Crohn’s disease symptoms well enough.

Remicade for ulcerative colitis

Ulcerative colitis is also a type of IBD, but you have inflammation in your colon (large intestine).

Remicade is FDA-approved to treat moderate to severe ulcerative colitis in adults as well as children ages 6 years and older. It’s approved for use when other conventional medications haven’t eased ulcerative colitis symptoms well enough.

Remicade for plaque psoriasis

Plaque psoriasis is a type of psoriasis in which red, itchy, red patches form on your skin.

Remicade is FDA-approved to treat chronic, severe plaque psoriasis in adults who:

• can take oral or injectable drugs that are systemic (work throughout the body)
• can’t take other conventional medications

Remicade for rheumatoid arthritis

With rheumatoid arthritis (RA), you have pain and inflammation in your joints and other body parts.

Remicade is FDA-approved to treat moderate to severe RA in adults. It’s used with the drug methotrexate.

Remicade for ankylosing spondylitis

Ankylosing spondylitis is a form of arthritis that mostly affects your spine.

Remicade is approved by the FDA to treat active ankylosing spondylitis in adults. “Active” means that you currently have symptoms.

Remicade for psoriatic arthritis

Psoriatic arthritis is a kind of joint swelling that can occur with the skin condition psoriasis.

Remicade is FDA-approved to treat active psoriatic arthritis in adults. “Active” means that you currently have symptoms.

Remicade effectiveness

Here are some examples of the effectiveness of Remicade in clinical studies:

• Crohn’s disease in adults. In a clinical study, adults with Crohn’s disease took Remicade. Between 39% and 46% of them were in disease remission (free from symptoms) after 30 weeks. In comparison, 25% of people who had one dose of Remicade followed by a placebo (treatment with no active drug) every 8 weeks had this result.
• Crohn’s disease in children. In a clinical study, children with Crohn’s disease took Remicade every 8 weeks or every 12 weeks. After 30 weeks of treatment, 60% of those who took Remicade every 8 weeks were free from symptoms. In comparison, 35% of children who took Remicade every 12 weeks had this response. Remicade wasn’t compared with a different drug or a placebo.
• Ulcerative colitis in adults. In clinical studies, people with ulcerative colitis took Remicade. Between 26% and 37% of them were free from symptoms after 30 weeks. In comparison, between 11% and 16% of people who took a placebo had this result.
• Ulcerative colitis in children. In a clinical study, children with ulcerative colitis took Remicade every 8 weeks or every 12 weeks. Of those who took Remicade every 8 weeks, 38% were free from symptoms after 54 weeks. Of those who took the drug every 12 weeks, 18% had this result. Remicade wasn’t compared with a different drug or a placebo.
• Rheumatoid arthritis. In a clinical study, people with rheumatoid arthritis took Remicade or a placebo. Both groups also took methotrexate. After 30 weeks, between 26% and 31% of the Remicade group saw a 50% improvement in symptoms. In comparison, 5% of people in the placebo group had this result.
• Ankylosing spondylitis. In a clinical study, people with ankylosing spondylitis took Remicade or a placebo. After 24 weeks, 44% of those who took Remicade saw their symptoms improve by at least 50%. In comparison, 9% of people who took a placebo had this result.
• Psoriatic arthritis. In a clinical study, people with psoriatic arthritis took Remicade or a placebo. After 6 months, 41% of those who took Remicade saw their symptoms improve by at least 50%. In comparison, 4% of people who took a placebo had this result.
• Plaque psoriasis. In clinical studies, people with plaque psoriasis took Remicade or placebo. After 10 weeks, 80% of those who took Remicade had no symptoms or minimal symptoms. In comparison, 4% of people who took a placebo had these results.

In many of these cases, people took other medications with Remicade. Examples of these drugs are methotrexate and corticosteroids, such as prednisone. How well Remicade works for you will depend on many factors. These include the symptoms of your disease, other health conditions you have, other medications you take, and your dose and treatment schedule.

Uses that are not approved

The FDA hasn’t approved Remicade to treat conditions other than the ones mentioned above. But sometimes the drug may be used off-label for other inflammatory diseases, which involve inflammation (swelling). Some of these conditions include:

Remicade for children

Remicade is approved by the FDA to treat children ages 6 years and older with moderate to severe Crohn’s disease or moderate to severe ulcerative colitis.

For information on the effectiveness of Remicade in treating these conditions, see the “Remicade effectiveness” section above.

It’s not known whether Remicade is safe to take during pregnancy. In animal studies, there was no harm to the developing baby when the mother took the drug. However, animal studies don’t always predict what will occur in humans.

You should only take Remicade during pregnancy if the benefits are greater than the risks.

If you’re pregnant or planning to become pregnant, talk with your doctor about whether Remicade is safe for you.

If you do take Remicade when you’re pregnant, your baby may have an increased risk for infection after birth. They shouldn’t get live vaccines for at least 6 months after they’re born to avoid serious infections.* A live vaccine contains a weakened form of a germ or virus. See the “Remicade and live vaccines” section below to learn more.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

It’s not known if Remicade is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Remicade.

It’s not known whether Remicade passes into breast milk. However, breastfeeding while taking Remicade isn’t recommended because of how severe the side effects of the drug can be.

If you’re breastfeeding and considering taking Remicade, talk with your doctor. They may recommend that you stop breastfeeding or delay treatment until you’re no longer breastfeeding.

Remicade is often used with other drugs in certain situations.

Combination therapy with methotrexate and other drugs

Your doctor may prescribe medication for you to take with Remicade to better control your symptoms. These drugs often ease inflammation (swelling) by treating different parts of your immune system than Remicade does.

For example, the American College of Gastroenterology recommends combination therapy for people with moderate to severe Crohn’s disease. The guidelines suggest using Remicade with medications such as azathioprine (Azasan, Imuran) or methotrexate (Otrexup, Rasuvo, RediTrex, Trexall, Xatmep). They also recommend taking corticosteroids, such as prednisone, with Remicade or other similar drugs.

Examples of other medications that may be used with Remicade to treat symptoms of rheumatoid arthritis (RA) include:

Examples of other medications that may be used with Remicade to treat symptoms of plaque psoriasis include:

• topical (treatment applied to the skin) corticosteroids, such as betamethasone (Beta-Val)
• topical calcipotriene (Dovonex, Enstilar, Sorilux)
• coal tar

Many of the conditions that Remicade treats can also be treated with similar additional medications. Talk with your doctor about the safety and effectiveness of all over-the-counter or prescription drugs you’re considering for your treatment.

Infusion reaction medications

Some people may have mild or moderate reactions during or shortly after receiving Remicade. Examples of possible symptoms include:

It’s common to take medications shortly before Remicade treatment to help prevent these reactions. These premedications include:

Remicade and alcohol don’t interact with each other.

While you take Remicade, it’s important to follow a healthy lifestyle. This helps your immune system work as well as possible.

Drinking too much alcohol can weaken your immune system. When your immune system isn’t strong enough to fight germs, you may be at risk for serious infections.*

Remicade has been linked to serious liver problems, which can lead to jaundice (yellowing of your skin and the white of your eyes). Drinking too much alcohol can damage your liver as well. So taking Remicade while drinking too much alcohol can increase your risk for liver problems.

If you take Remicade, talk with your doctor about whether drinking alcohol is safe for you.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Remicade can interact with several other medications. It can also interact with certain supplements and foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Remicade and other medications

Below is a list of medications that can interact with Remicade. This list doesn’t contain all drugs that may interact with Remicade.

Before taking Remicade, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Remicade with methotrexate

It’s not known exactly whether Remicade and methotrexate interact with each other. However, Remicade is prescribed with methotrexate for many autoimmune diseases (conditions in which your immune system attacks your body by mistake). These include rheumatoid arthritis (RA) and psoriatic arthritis.

In fact, taking methotrexate with Remicade may lower the risk of developing antibodies to Remicade. (Antibodies are immune system proteins that attack substances, such as Remicade, and can make them less effective.) Methotrexate may also increase how much Remicade circulates through your body. In both cases, Remicade may be more effective.

It’s also possible that taking Remicade with another medication that weakens your immune system could increase your risk for infections and cancer.* Your doctor will monitor you closely for infections and cancer if you take Remicade, with or without methotrexate.

* Remicade has boxed warnings for serious infections and cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Remicade and certain medications that weaken the immune system

Taking Remicade with certain biologic medications (drugs made from living organisms) can further weaken your immune system. This increases your risk for serious infections.*

Examples of medications that can weaken the immune system and shouldn’t be taken with Remicade include:

If you’re taking any of these medications, talk with your doctor before you start taking Remicade. They may recommend other treatment options.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Remicade and live vaccines

You shouldn’t receive live vaccines while taking Remicade. The drug decreases your immune system’s ability to fight infections.* So you may be at risk for the infection that the vaccine typically helps prevent.

Examples of live vaccines to avoid while taking Remicade include:

Before starting Remicade, make sure you’re up to date on all vaccines. If you need a live vaccine, get it before you start your Remicade treatment.

Live vaccines and babies

If you took Remicade while pregnant, your baby shouldn’t get live vaccines until they’re at least 6 months old. Babies exposed to Remicade before birth and who get vaccines too soon can have a higher risk for infections, serious complications, or death.

Here are some live vaccines that your baby shouldn’t receive for at least 6 months after birth:

If you have questions about what vaccines your baby needs and when they should have them, talk with your child’s doctor.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Remicade and warfarin

Taking Remicade with warfarin (Coumadin, Jantoven) may affect how quickly your body metabolizes (breaks down) warfarin. This could change how effective warfarin is at helping prevent blood clots. When you start or stop taking Remicade, your doctor will monitor your body’s response to warfarin. You may need a different dose of warfarin.

Remicade and theophylline

Taking Remicade with theophylline (Theocron, Theo-24, others) may affect how your body metabolizes (breaks down) theophylline. This could change how safe and effective theophylline will be. When you start or stop taking Remicade, your doctor will monitor your body’s response to theophylline. You may need a different dose of theophylline.

Remicade and cyclosporine

Taking Remicade with cyclosporine (Restasis, Sandimmune, others) may affect how your body metabolizes (breaks down) cyclosporine. This could change how safe and effective cyclosporine will be. When you start or stop taking Remicade, your doctor will monitor your body’s response to cyclosporine. You may need a different dose of cyclosporine.

Remicade and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Remicade, according to the drug’s manufacturer.

However, you should still check with your doctor or pharmacist before using any of these products while taking Remicade.

Remicade and foods

There aren’t any foods that have been specifically reported by the manufacturer that interact with Remicade. If you have any questions about eating certain foods with Remicade, talk with your doctor.

Remicade is used to treat certain autoimmune diseases. These are conditions in which your immune system mistakenly attacks your body’s own tissues or organs.

Remicade blocks the action of tumor necrosis factor-alpha (TNF-alpha). It’s an immune system protein in your body that’s involved in inflammation (swelling).

Most people with autoimmune diseases have higher-than-normal levels of TNF-alpha and too much inflammation. By blocking the activity of TNF-alpha, Remicade helps limit your immune system’s attack on healthy organs and body parts.

How long does it take to work?

Remicade starts to affect your immune system right away. But you may not see your symptoms improve for several days to weeks.

Here are answers to some frequently asked questions about Remicade.

Will I have withdrawal symptoms if I stop taking Remicade?

No, you won’t have actual withdrawal symptoms. But you may have more symptoms of your condition or they may worsen if you stop taking Remicade.

In a small study, researchers tested the outcomes of stopping Remicade treatment. They found that 72.1% of people needed medication to treat their condition after they stopped taking Remicade.

This study included people with Crohn’s disease. They were in clinical remission (free from symptoms) at the time they stopped using Remicade. People stayed symptom free for an average of 1 year after they stopped taking Remicade.

If you have questions about what to expect when your doctor ends your Remicade treatment, talk with them.

Is Remicade a form of chemotherapy?

No, Remicade isn’t a form of chemotherapy. Remicade is a biologic, which means it’s made from living organisms. Specifically, Remicade is monoclonal antibody that’s made from immune system cells in a lab. Monoclonal antibodies only block the activity of certain proteins in the body.

Chemotherapy, on the other hand, is a chemical drug that destroys rapidly growing cells throughout the body. It’s typically used to treat cancer. Chemotherapy medications affect many types of cells and organs. This is different from the very specific actions of monoclonal antibodies, such as Remicade.

Can Remicade cause cancer?

It’s not clear whether Remicade causes cancer.

There have been reports of new or unusual cancers* with the use of Remicade and other drugs in the tumor necrosis factor-alpha (TNF-alpha) blockers class. (A class of drugs is a group of medications that work in a similar way.)

Some of the cancers included lymphoma (cancer of the lymphatic system), skin cancer, and cervical cancer. Many of the cases occurred in younger males, with the exception of cervical cancer.

However, in a review of multiple studies, the evidence for cancer risk was conflicting. Analyses of studies and registries that collect information from larger populations have also had conflicting results.

If you have concerns about cancer, talk with your doctor about your medical history and your risk for cancer. They’ll explain the benefits and risks of taking Remicade. For more information about Remicade and cancer, see the “Remicade side effects” section above.

* Remicade has a boxed warning for cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Could Remicade stop working for me?

Yes. Remicade may become less effective for you over time. This can occur if your body’s immune system starts to recognize Remicade as a foreign invader and makes antibodies to Remicade. Antibodies are immune system proteins that fight foreign substances, including medications such as Remicade.

If your body makes anti-Remicade antibodies, the drug will clear from your system faster and won’t be as effective.

Remicade may also stop working for a time because of stress, dietary choices, or other health conditions.

If you’re concerned about how effective Remicade is in treating your condition, talk with your doctor.

Can I get vaccines while being treated with Remicade?

Yes and no. You can get inactive (not live) vaccines while taking Remicade. Inactive vaccines are made from germs that have been killed. Many of the vaccines that doctors recommend are inactive.

However, Remicade can weaken your immune system’s ability to fight infections.* So you shouldn’t get live vaccines during treatment. Live vaccines are made from weakened forms of germs. Examples of live vaccines to avoid while taking Remicade include the measles, mumps, and rubella (MMR) vaccine and the yellow fever vaccine. For more information, see the “Remicade interactions” section above.

Before you start taking Remicade, check with your doctor to see if you’re up to date on your vaccines.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Serious infections. People who take Remicade have an increased risk for serious infections that may lead to a hospital stay or death. These include tuberculosis (TB), fungal infections throughout the body, and other bacterial and viral infections. Before you start taking Remicade, your doctor will test you for TB and monitor you for it during your treatment. If you develop a serious infection while using Remicade, your doctor will have you stop taking the drug.

Cancers. Certain cancers, including lymphoma (cancer of the lymphatic system) and skin cancer, have been reported in people who took Remicade or other medications called tumor necrosis factor (TNF) blockers. (Remicade is a TNF blocker.) Some of the cases that occurred in children and teens were fatal.

One specific kind of lymphoma was hepatosplenic T-cell lymphoma. Most of the people who developed it were teenage or young adult males who had ulcerative colitis or Crohn’s disease. Nearly all of them were also taking a TNF blocker with the drugs azathioprine or 6-mercaptopurine.

Your doctor will screen you regularly for cancer during and after Remicade treatment.

Other precautions

Before taking Remicade, talk with your doctor about your health history. Remicade may not be right for you if you have certain medical conditions. These include:

• Current infections. Remicade can weaken your immune system, making it less able to fight germs. This can lead to serious infections. Talk with your doctor about any current or past infections you’ve had. If you have a history of certain infections, you may need to delay starting Remicade until the infection has been treated.
• Cancers. Cancers have been reported in people treated with Remicade. Tell your doctor if you’ve had cancer in the past. They can discuss the risks and benefits of Remicade treatment.
• Hepatitis B. Remicade can reactivate the hepatitis B virus if you were infected with the virus in the past. Your doctor will test you for hepatitis B before you start taking Remicade. If you test positive for hepatitis B, your doctor will monitor you closely for signs and symptoms of the virus during your Remicade treatment. You may require more treatment for hepatitis B.
• Liver damage. Severe liver damage has been reported in people who received Remicade. In certain cases, liver damage led to liver failure, liver transplant, and death. Talk with your doctor about any history of liver damage or liver disease you have. They’ll monitor you closely for signs and symptoms of worsening liver function during your Remicade treatment.
• Heart failure. People have had new or worsening heart failure while receiving Remicade. Certain doses of Remicade aren’t safe for people with moderate or severe heart failure. Tell your doctor if you have heart failure or a history of heart disease. They’ll discuss the risks and benefits of Remicade treatment.
• Blood disorders. Blood disorders, including low levels of white blood cells, have been reported with Remicade treatment. Some cases have led to death. Tell your doctor if you have a history of blood disorders. They’ll monitor you closely for signs and symptoms of worsening blood disorders while you receive Remicade.
• Serious infusion reactions. People have had serious cardiovascular (heart and blood vessel) or brain problems during or within hours of receiving a Remicade infusion. Examples of these problems include heart attack, stroke, low or high blood pressure, and abnormal heart rhythm (heartbeat that’s too fast, too slow, or irregular). Tell your doctor if you have a history of serious infusion reactions or cardiovascular or brain problems. They’ll monitor you closely during and after your infusions.
• Nervous system reactions. Some people have had new or worsening central nervous system disorders while taking Remicade. These include seizures and multiple sclerosis. Tell your doctor if you have a nervous system disorder or had one in the past. They’ll monitor you closely for new or worsening symptoms during your Remicade treatment.
• Allergic reaction. If you’ve had a severe allergic reaction to Remicade or any of its ingredients, you shouldn’t take Remicade. Ask your doctor what other treatments are better choices for you.
• Pregnancy. It’s not known whether Remicade is safe to take during pregnancy. For more information, please see the “Remicade and pregnancy” section above.
• Breastfeeding. Breastfeeding while taking Remicade isn’t recommended. For more information, please see the “Remicade and breastfeeding” section above.

Note: For more information about the potential negative effects of Remicade, see the “Remicade side effects” section above.

The following information is provided for clinicians and other healthcare professionals.

Indications

Remicade (infliximab) is FDA-approved to treat the following:

Administration

Remicade is administered by intravenous infusion.

Mechanism of action

Remicade is a monoclonal antibody that binds to tumor necrosis factor-alpha ligand and prevents it from binding to receptors. This results in decreased downstream immune system activation, including induction, migration, and activity of cytokines and immune system proteins and cells.

Pharmacokinetics and metabolism

Distribution is primarily in the vasculature. Metabolism is expected to occur via catabolism to smaller peptides and amino acids.

The median terminal half-life of Remicade is 7.7 to 9.5 days. There is no evidence of systemic accumulation following repeated doses, but clearance is increased in the presence of anti-infliximab antibodies.

Age, weight, and gender have no effect on clearance or volume of distribution.

Contraindications

Remicade in doses greater than 5 mg/kg is contraindicated for use in people with moderate to severe heart failure.

Remicade is also contraindicated in people with:

• a history of severe hypersensitivity reactions to the drug
• a history of hypersensitivity to any component of the drug or to murine proteins

Storage

Unopened vials of Remicade should be stored in the refrigerator at temperatures of 36°F to 46°F (2°C to 8°C).

Unopened vials may also be stored at room temperature (maximum of 86°F/30°C) for up to 6 months (but not exceeding the original expiration date). If storing vials at room temperature, the new expiration date should be written on the carton. Do not return the vials to the refrigerator.

Remicade vials do not contain preservatives.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Side effects, antibodies, cost, and more

Remicade is a brand-name prescription medication. It’s FDA-approved to treat certain autoimmune diseases in adults and children. These are conditions in which your immune system mistakenly attacks your body’s own tissues or organs. Conditions that Remicade is used to treat are:

Remicade is a treatment option for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, the drug is usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Remicade drug class and form

Remicade contains the drug infliximab, which is a biologic (a drug made from parts of living organisms). Remicade belongs to a drug class called tumor necrosis factor-alpha (TNF-alpha) blockers. A class of drugs is a group of medications that work in a similar way.

Remicade comes as a vial of powder that’s mixed with a liquid solution. The drug is available in one strength: 100 mg.

A healthcare provider will give you Remicade as an infusion. This is an injection into your vein that’s given over a period of time. Remicade infusions are typically about 2 hours long. You’ll usually receive an infusion every few weeks, but the timing depends on the condition that’s being treated.

Effectiveness

For information on the effectiveness of Remicade, please see the “Remicade uses” section below.

Remicade is available only as a brand-name medication. It contains the active drug ingredient infliximab.

The Food and Drug Administration (FDA) has approved four biosimilar versions of Remicade: Avsola, Inflectra, Ixifi, and Renflexis.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

Remicade can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Remicade. These lists don’t include all possible side effects.

For more information on the possible side effects of Remicade, talk with your doctor or pharmacist. They can also give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Remicade, you can do so through MedWatch.

More common side effects

The more common side effects of Remicade can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Remicade aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• New or worsening heart failure. Symptoms can include:
  • edema (swelling, typically in your ankles and feet)
• Heart attack. Symptoms can include:
  • lightheadedness or fainting
• Abnormal heart rhythms. Symptoms can include:
• Stroke. Symptoms can include:
  • weakness on one side of the body
  • trouble speaking or understanding others
  • trouble seeing in one or both of the eyes
  • trouble standing or walking
• Liver problems. Symptoms can include:
  • jaundice (yellowing of your skin and the white of your eyes)
  • pain on the right side of your belly
• Blood disorders, such as a low level of white blood cells. Symptoms can include:
  • bruising or bleeding easily
  • fever that lasts longer than 48 hours
• Nervous system disorders, such as seizures or vision problems. Symptoms can include:
  • numbness or tingling of body parts
  • weakness in your arms or legs
  • vision loss or changes in how you see color
• New or worsening psoriasis (a condition in which itchy, red patches form on your skin). Symptoms include:
  • scaly, red patches on skin
  • raised bumps on skin that are filled with pus
• Infusion reactions (symptoms or side effects that typically occur within 2 hours of your infusion). Symptoms can include:
  • chills (feeling cold for no reason)
• Certain cancers,* such as lymphomas (cancers of the lymphatic system). Symptoms can include:

Other serious side effects, explained in more detail below in “Side effect details,” include:

* Remicade has boxed warnings for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Side effects in children

In clinical studies, children with Crohn’s disease or ulcerative colitis had certain side effects more often than adults.

Side effects that occurred more often in children were:

• anemia (low level of red blood cells)
• low level of white blood cells
• flushing (warmth and redness in the skin)
• bacterial and viral infections
• bone fractures
• allergic reactions of the throat and lungs

Your doctor will monitor your child for these side effects during and after Remicade treatment.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, you may have an allergic reaction after taking Remicade. In clinical studies of people who took Remicade to treat rheumatoid arthritis (RA), at least 0.2% had an allergic reaction. Remicade wasn’t compared with a different drug or a placebo (treatment with no active drug.

In a study of children with Crohn’s disease, 6% of those who took Remicade had an allergic reaction that affected their lungs. Remicade wasn’t compared with a different drug or a placebo.

And in a study of adults with plaque psoriasis, 1% of people who took Remicade had a possible allergic reaction that occurred within 2 weeks after the infusion. Again, Remicade wasn’t compared with a different drug or a placebo.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

It’s also possible to have an allergic reaction after taking Remicade for a while. Or you may have an allergic reaction if you receive a Remicade infusion after a break in treatment. In addition to the usual allergic reaction symptoms, you may have:

• fever
• headache
• sore throat
• muscle and joint pain

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Remicade. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Long-term side effects

Side effects can occur if Remicade is taken over a long period time of time. These long-term side effects are similar to those seen in clinical studies.

In one long-term study, 23.3% of people who took Remicade had long-term side effects. This was compared with 11% of people who took a different TNF inhibitor. However, long-term side effects may vary depending on what condition you’re using the drug to treat and what other medications you’re taking with Remicade.

Safety concerns with long-term Remicade use include:

• increased risk of infections, such as TB or hepatitis B
• new or worsening heart failure or other heart problems, such as heart attack
• blood disorders, such as a low level of white blood cells
• liver problems, which can lead to jaundice
• nervous system disorders, such as seizures
• lupus-like syndrome (an immune system reaction)
• increased risk of certain cancers, such as lymphomas (cancers in the lymphatic system)

Some people treated with Remicade develop antibodies to the drug. These antibodies are immune system proteins that mistakenly attack the drug. If this occurs, Remicade may no longer work for you.

If you’re concerned about possible long-term side effects of Remicade, talk with your doctor.

Headache

Headache was one of the most common side effects seen in Remicade clinical studies. For example, 18% of people with RA who received Remicade had headaches. This was compared with 14% of people who took a placebo. Rates of headache may vary depending on what condition you’re using Remicade to treat.

Headache may also be a symptom of infusion reactions. These are symptoms or side effects that occur during or shortly after an infusion. Infusion reactions were one of the most common reasons that people stopped taking Remicade.

A headache may also be part of a delayed allergic reaction. This occurs several hours to days after an infusion.

A severe headache could be a sign of something more serious, such as a stroke. Other signs of a stroke include trouble walking or speaking, dizziness, or confusion.

If you have a headache that’s very painful or doesn’t improve with medication, call your doctor right away. If you feel like you’re having a medical emergency, call 911.

Rash

In a clinical study of people with RA, 10% of those who took Remicade had rashes. In comparison, rash occurred in 5% of people who took a placebo. Rates of rash may vary depending on what condition you’re using Remicade to treat.

Rash is also a symptom of infusion reactions. These are side effects or symptoms that occur during or shortly after an infusion.

In addition, rash is a common symptom of lupus-like syndrome, an immune system reaction that can occur during Remicade treatment.

If you develop a rash while taking Remicade, talk with your doctor about possible remedies. If the rash is mild, they may recommend topical medication (treatment applied to the skin). If the rash is more serious, they may want you to stop taking Remicade and switch to a different drug.

Fatigue

In clinical studies, 9% of people with RA who took Remicade had fatigue (lack of energy). In comparison, 7% of people who took a placebo had fatigue. Rates of fatigue may vary depending on what condition you’re using Remicade to treat.

Fatigue can also be a symptom of more serious Remicade side effects, such as infections or liver problems.

In addition, fatigue is a common symptom of many autoimmune diseases (conditions in which your immune system attacks your body by mistake). Fatigue may be caused by:

• inflammation (swelling)
• stress
• lack of sleep
• pain
• other factors

If fatigue is harming your quality of life while you take Remicade, talk with your doctor. They can suggest ways to boost your energy levels.

Joint pain

In clinical studies, 8% of people with RA who took Remicade had joint pain.

Joint pain was also a side effect of delayed reactions, along with muscle pain, fever, and rash.

In addition, joint pain was reported in people whose tuberculosis (TB) or hepatitis B reactivated (came back) or who developed a new case of lupus-like syndrome (an immune system reaction).

Remicade is used to treat conditions that have symptoms such as joint pain. So it may be hard to determine whether Remicade or the disease is causing the joint pain.

If you have new or worsening joint pain, talk with your doctor. They’ll check to see if there are other conditions that may be causing the pain. Your doctor can also recommend pain medication to help ease your discomfort.

Lupus

Lupus-like syndrome (an immune system reaction) has been reported in clinical studies of Remicade. Symptoms include:

• shortness of breath
• chest pain or discomfort
• joint pain
• rashes on arms or cheeks, which tend to get worse in sunlight

Some people have also had fever, weight loss, and malaise (feeling weak, tired, and simply not well). Rare but serious symptoms of lupus-like syndrome can include lung inflammation (swelling), nerve problems, and blood clots. Symptoms can occur within months to years of starting Remicade use.

It’s thought that Remicade causes a lupus-like syndrome because of the development of autoantibodies following treatment. Autoantibodies are immune system proteins made in your body. They mistakenly attack your own tissues or organs.

If you have lupus-like syndrome, your doctor may recommend that you stop taking Remicade. Symptoms usually go away within weeks to months after ending Remicade treatment.

Cancer/lymphoma

New cases of cancers* were reported in people who took Remicade in clinical trials and in people taking the drug after it was made available to the public. Cancer cases were also reported in people who took other drugs in the tumor necrosis factor-alpha (TNF-alpha) blocker class. This is the drug class that Remicade is in.

However, it’s not clear whether Remicade causes cancer.

Types of cancer

About half of the cancers were lymphomas (cancers in the lymphatic system). Cells in the lymph system usually fight off infections, but they can become cancerous. Types of lymphatic system cancers include Hodgkin lymphoma and non-Hodgkin lymphoma.

Other types of cancers reported were skin cancer, cervical cancer, breast cancer, colorectal cancer, and the rare hepatosplenic T-cell lymphoma.

People with chronic obstructive pulmonary disease (COPD) also had new cases of lung cancer, or head or neck cancer. Many cases of cancer occurred in children, teenagers, and young adults. Most of the new cancer cases occurred in people who were taking additional drugs that weakened their immune system.

The following people may be at greater risk for developing cancer when taking Remicade:

• those with COPD
• women older than age 60 years who have RA
• those with Crohn’s disease or ulcerative colitis and who are taking a TNF-alpha blocker as well as azathioprine or methotrexate
• those who have a very active autoimmune disease (a condition in which your immune system attacks your body by mistake) and have been treated for a long time

Statistics

In clinical trials of various conditions,** new lymphoma cancers occurred at a rate of 1 case for every 1,000 people who took Remicade for a year. This rate is about four times higher than is seen in the general population.

In clinical trials of various conditions,** new cases of cancer (excluding lymphoma and skin cancer) occurred at a rate of about 5 cases for every 1,000 people who took Remicade for a year. This rate is similar to what’s expected in the general population.

Remicade risk

Again, we don’t know whether Remicade actually causes cancer. A review of multiple studies found that the evidence of cancer risk was conflicting. Analyses of studies and registries that collect information from larger populations also have conflicting results.

If you have concerns about cancer, talk with your doctor about your medical history and your risk for cancer. They’ll explain the benefits and risks of taking Remicade.

* Remicade has a boxed warning for cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

** Rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis

Serious infections

Remicade can increase the risk of serious infections.* These infections include tuberculosis (TB), hepatitis B, fungal infections throughout the body, and other bacterial and viral infections.

In clinical trials of Remicade, 36% of people who took Remicade received treatment for an infection. This was compared with 25% of people who took a placebo. It’s not known how many people had an infection but didn’t receive treatment for it.

Serious infections occurred at lower rates, however. For example, in clinical studies of RA, 5.3% of people who took Remicade had a serious infection. This was compared to 3.4% of people who took a placebo. Both groups also took methotrexate.

In one clinical study of children with ulcerative colitis, 12% of those who took Remicade had a serious infection. Remicade wasn’t compared with a different drug or a placebo.

Symptoms of serious infections

Symptoms of serious infections can include:

• cough
• fever
• tiredness
• lack of appetite
• rash
• flu-like symptoms (such as a runny nose, chills, and muscle aches)

Your doctor will monitor you closely for symptoms of infection during and after Remicade treatment. You may need to be treated for an infection before you start to take Remicade. This is for cases in which you have an infection but don’t have symptoms yet.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Weight gain

Weight gain wasn’t a side effect reported in the initial clinical studies of Remicade.

However, it has been seen in some other studies:

• A small survey was conducted in people with various conditions who took tumor necrosis factor-alpha (TNF-alpha) drugs. This is the drug class that includes Remicade. (A drug class is a group of medications that work in a similar way.) The survey found that 13.3% of the people gained weight. The average weight gain was about 12 pounds (5.5 kilograms).
• In another small study, 68% of people with Crohn’s disease gained weight after taking Remicade for a year. Remicade wasn’t compared with a different drug or a placebo.
• And in a different small study of people with psoriasis, those treated with Remicade gained about 6 pounds (2.9 kilograms) on average. In comparison, no weight gain was reported in people who took the psoriasis drugs ustekinumab or secukinumab.

Very sudden weight gain may also be a sign of new or worsening heart failure.

If you’re concerned about weight gain, talk with your doctor about possible causes. They can suggest ways you can manage your weight.

Depression (not a side effect)

Depression wasn’t reported as a side effect in Remicade clinical studies. However, many people who have an autoimmune disease (a condition in which your immune system attacks your body by mistake) do have depression because of their disease. This depression may be caused by:

• inflammation (swelling)
• pain
• stress
• lack of sleep
• other factors

In clinical studies of people with inflammation conditions, such as psoriasis or Crohn’s disease, Remicade was found to be significantly more effective for easing depressive symptoms than a placebo. It’s not clear why, but a reduction in inflammation may have played a role.

If you think you might have depression, talk with your doctor. They can recommend treatments to help ease your symptoms.

Hair loss (not a side effect)

Hair loss wasn’t a side effect reported in clinical trials of Remicade.

In one study, about 3% of people had hair loss while taking tumor necrosis factor-alpha (TNF-alpha) medications. These drugs are in the same class as Remicade. (A drug class is a group of medications that work in a similar way.) The TNF-alpha drugs weren’t compared with a different drug or a placebo.

In another study, people who took Remicade had new or worsening cases of psoriasis. Symptoms can include itchy rashes or plaques (red, inflamed patches) on the scalp. These can lead to hair loss in that area. Plaques can also form on the arms or legs, which can lead to hair loss there, too.

It’s not known why Remicade causes psoriasis in some people because the Food and Drug Administration (FDA) has approved the drug to actually treat psoriasis.

In some cases, people’s hair started growing again after they stopped taking Remicade.

If your doctor wants you to keep using Remicade, topical treatments may help lessen hair loss due to psoriasis. (Topical treatments are applied to the skin.) If you have any concerns about hair loss, talk with your doctor.

Effects on teeth (not a side effect)

In clinical studies, people who took Remicade didn’t have any side effects related to teeth.

However, people taking Remicade are at an increased risk of infections. These can include infections that may occur following dental procedures.

If you’re taking Remicade, talk with your doctor and dentist. They can advise you on how to keep your mouth healthy and help prevent infections related to dental procedures.

Some people’s immune systems will develop antidrug antibodies to Remicade. Antibodies are immune system proteins that the body develops in response to foreign substances. Antibodies to Remicade will mistakenly attack the drug and clear it from your body more quickly.

Developing antibodies to Remicade can cause the drug to be less effective for you. It may also increase your risk of having a reaction to Remicade infusions. If you have a reaction, your doctor may recommend switching to a different medication.

In one study, researchers reviewed several clinical trials. They found that people who took Remicade had one of the highest rates of antidrug antibody formation. This was compared with people who took other biologic drugs for their conditions. (A biologic is made from parts of living organisms.)

If you’re taking higher doses of Remicade or taking Remicade with other drugs, you’re more likely to develop antibodies to Remicade.

If you have any questions about antibodies and Remicade, talk with your doctor.

As with all medications, the cost of Remicade can vary.

The actual price you’ll pay depends on your insurance coverage and your location.

Your insurance plan may require you to get prior authorization before approving coverage for Remicade. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Remicade.

If you’re not sure if you’ll need to get prior authorization for Remicade, contact your insurance company.

Financial assistance

If you need financial support to pay for Remicade, help is available. Janssen, the manufacturer of Remicade, offers a program called Janssen CarePath. For more information and to find out if you’re eligible for support, call 877-CarePath (877-227-3728) or visit the program website.

The Remicade dosage that your doctor prescribes will depend on several factors. These include:

• the condition you’re using Remicade to treat
• how much you weigh
• how well your body responds to Remicade treatment

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Remicade comes as a vial of powder, and each vial contains 100 mg of infliximab (the active drug in Remicade). Your healthcare provider will add a liquid to the vial to make a solution.

Then the healthcare provider will give you the Remicade solution as an infusion. This is an injection into your vein that’s given over a period of time.

Remicade infusions are typically about 2 hours long.

Dosage for FDA-approved indications

Your Remicade dosage will be based on your weight and the condition you’re taking Remicade for.

Remicade is given in two stages: an induction (beginning) stage and a maintenance stage.

In the induction stage, you’ll receive Remicade infusions at week 0, week 2, and week 6. After the induction stage, you’ll receive maintenance infusions every 6 or 8 weeks.

You may need higher doses or more frequent doses to help control your condition.

Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis

Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis have the same recommended dosing for adults. You’ll receive induction infusions of 5 mg/kg (5 mg/2.2 lb) at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 5 mg/kg every 8 weeks thereafter.

Here’s an example of how Remicade dosages are usually calculated: A 176-pound (80-kg) man taking Remicade for Crohn’s disease would receive a dose of about 400 mg in each infusion.

Rheumatoid arthritis

For rheumatoid arthritis (RA) in adults, the recommended dosing is induction infusions of 3 mg/kg (3 mg/2.2 lb) at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 3 mg/kg every 8 weeks thereafter.

Ankylosing spondylitis

For ankylosing spondylitis in adults, the recommended dosing is induction infusions of 5 mg/kg (5 mg/2.2 lb) at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 5 mg/kg every 6 weeks thereafter.

Pediatric dosage

The Food and Drug Administration (FDA) has approved Remicade to treat children with Crohn’s disease or ulcerative colitis.

The dosage for children is the same as for adults. The induction (beginning) stage of dosing is 5 mg/kg (5 mg/2.2 lb) at weeks 0, 2, and 6. That’s followed by maintenance dosing of 5 mg/kg every 8 weeks.

What if I miss a dose?

It’s important to attend all your infusion visits. This gives you the best chance of improving your condition. If you regularly miss infusion appointments, your condition may worsen.

If you can’t make an appointment or forget to go, call your doctor’s office right away. The staff can reschedule your infusion. They may adjust the timing of your next visit based on when you had your most recent infusion.

When you make an appointment, write it down on a calendar. Or put a reminder on your phone so you can stay on track with your infusions.

Will I need to use this drug long term?

Remicade is meant to be used as a long-term treatment. If you and your doctor determine that Remicade is safe and effective for you, you’ll likely take it long term.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Remicade, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for moderate to severe Crohn’s disease

According to treatment guidelines, other drugs that may be used to treat Crohn’s disease include:

• oral corticosteroids, such as prednisone
• azathioprine (Azasan, Imuran)
• 6-mercaptopurine (Purinethol, Purixan)
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
• vedolizumab (Entyvio)
• natalizumab (Tysabri)
• ustekinumab (Stelara)

Alternatives for ulcerative colitis

According to treatment guidelines, other drugs that may be used to treat ulcerative colitis include:

• oral corticosteroids, such as prednisone

• mesalamine (Apriso, Asacol HD, Canasa, SfRowasa)
• balsalazide (Colazal, Giazo)
• olsalazine (Dipentum)
• rectal hydrocortisone (Cortifoam)
• azathioprine (Azasan, Imuran)
• 6-mercaptopurine (Purinethol, Purixan)

Alternatives for rheumatoid arthritis

According to treatment guidelines, other drugs that may be used to treat rheumatoid arthritis include:

• oral corticosteroids, such as prednisone
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• sulfasalazine (Azulfidine)
• hydroxychloroquine (Plaquenil)
• leflunomide (Arava)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
• golimumab (Simponi)
• certolizumab pegol (Cimzia)
• etanercept (Enbrel, Erelzi)
• abatacept (Orencia)
• tocilizumab (Actemra)

Alternatives for ankylosing spondylitis

According to treatment guidelines, other drugs may be used to treat ankylosing spondylitis. Some of these drugs are:

Alternatives for psoriatic arthritis

According to treatment guidelines, other drugs that may be used to psoriatic arthritis are:

• NSAIDS, such as naproxen (Aleve, Naprosyn) and celecoxib (Celebrex)
• oral or injectable corticosteroids, such as prednisone, methylprednisolone (Depo-Medrol, Medrol), hydrocortisone (Solu-Cortef)
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• sulfasalazine (Azulfidine)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
• golimumab (Simponi)
• certolizumab pegol (Cimzia)
• etanercept (Enbrel, Erelzi)
• ustekinumab (Stelara)
• secukinumab (Cosentyx)
• abatacept (Orencia)

Alternatives for plaque psoriasis

According to treatment guidelines, other drugs that may be used to treat plaque psoriasis include:

• topical (treatment applied to the skin) corticosteroids
• topical vitamin D analogues, such as calcipotriene (Dovonex, Enstilar, Sorilux), calcitriol (Vectical)
• topical retinoids, such as tazarotene (Tazorac)
• topical coal tar
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• etanercept (Enbrel, Erelzi)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)

You may wonder how Remicade compares with other medications that are prescribed for similar uses. Here we look at how Remicade and Humira are alike and different.

Ingredients

Remicade contains the drug infliximab. Humira contains the drug adalimumab.

Uses

The Food and Drug Administration (FDA) has approved both Remicade and Humira to treat the following conditions:

Humira is also FDA-approved to treat:

Remicade and Humira are considered treatment options for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, the drugs are usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Drug forms and administration

Remicade comes as a vial of powder. Your healthcare provider will mix it with a liquid to make a solution. They will then give you the Remicade solution as an infusion. This is an injection into your vein that’s given over a period of time.

You’ll go to your doctor’s office or a clinic to have the infusions. Remicade infusions are typically around 2 hours long. The usual dosing schedule is once every 8 weeks after you complete the first stage of dosing.

Humira comes in three forms:

• a prefilled, single-dose syringe
• a prefilled, single-dose pen
• a single-dose vial for use only by a healthcare provider

Humira is given as an injection just under your skin (subcutaneous). A healthcare provider can give you the injections, or you can inject yourself at home. The usual dosing schedule is one injection every other week.

Side effects and risks

Remicade and Humira work in different ways but have some similar side effects. Examples of common and serious side effects for each drug are listed below.

People in both Remicade clinical studies and Humira clinical studies had side effects. But these may be symptoms of other side effects. For example, a fever may be a symptom of an infection. Side effects may overlap between the drugs.

More common side effects

Here are examples of more common side effects that can occur with Remicade, with Humira, or with both drugs (when taken individually).

• Can occur with Remicade:
• Can occur with Humira:
  • injection site reactions (redness, swelling, or pain where you had the injection)
  • rash
• Can occur with both Remicade and Humira:

Serious side effects

Here are examples of serious side effects that can occur with Remicade, with Humira, or with both drugs (when taken individually).

• Can occur with Remicade:
  • infusion reactions (side effects or symptoms that occur during or shortly after an infusion), such as rash
• Can occur with Humira:
  • few unique serious side effects
• Can occur with both Remicade and Humira:

* Remicade and Humira have boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information about Remicade’s boxed warnings, see “FDA warnings” at the beginning of this article.

Effectiveness

Remicade and Humira have different FDA-approved uses. But they’re both used to treat the following conditions:

• Crohn’s disease
• ulcerative colitis
• rheumatoid arthritis
• ankylosing spondylitis
• psoriatic arthritis
• plaque psoriasis

These drugs haven’t been directly compared in clinical studies, but studies have found both Remicade and Humira to be effective for treating the conditions mentioned above.

Costs

Remicade and Humira are both brand-name drugs. Biosimilars of both Remicade and Humira are FDA-approved.

• Remicade’s biosimilars are Inflectra, Ixifi, Avsola, and Renflexis.
• Humira’s biosimilars are Hadlima, Cyltezo, Hyrimoz, Abrilada, and Amjevita.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

The cost of Remicade and Humira depends on many factors, including the form used, the dosage, and the length of treatment. To learn more about cost for both drugs, visit GoodRx.

Like Humira (above), the drug Inflectra (infliximab-dyyb) has uses similar to those of Remicade. Here’s a comparison of how Remicade and Inflectra are alike and different.

Ingredients

Remicade contains the drug infliximab.

Inflectra contains infliximab-dyyb, a biosimilar of infliximab.

Biosimilars are biologic drugs made from living organisms. They are very similar to another medication (a reference drug) approved by the Food and Drug Administration (FDA).

Remicade is the reference drug for Inflectra. The “-dyyb” ending is added to the drug name to show that Remicade and Inflectra are two different products.

The FDA has reviewed how safe and effective biosimilars and their reference drugs are. The two medications act in very similar ways in the body. There aren’t any major differences in how they work. So the information for Remicade and its biosimilar Inflectra is alike.

Uses

Remicade and Inflectra are FDA-approved to treat people with the following conditions:

Remicade and Inflectra are considered treatment options for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, these drugs are usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Drug forms and administration

Remicade and Inflectra both come as a vial of powder. Your healthcare provider will mix it with a liquid to make a solution.

Both drugs are given as an infusion. This is an injection into your vein that’s given over a period of time.

You’ll go to your doctor’s office or a clinic to have the infusions. Remicade and Inflectra infusions are usually about 2 hours long. The usual dosing schedule is once every 8 weeks after you complete the first stage of dosing.

Side effects and risks

Because Inflectra is a biosimilar of infliximab (the active drug in Remicade), Inflectra and Remicade have the same side effects. Examples of common and serious side effects for each drug are listed below.

More common side effects

This list contains more common side effects that can occur with both Remicade and Inflectra (when taken individually):

Serious side effects

Here are examples of serious side effects that can occur with Remicade and Inflectra (when taken individually):

* Remicade and Inflectra have boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information about Remicade’s boxed warnings, see “FDA warnings” at the beginning of this article.

Effectiveness

Remicade and Inflectra have the same FDA-approved uses.

The FDA has reviewed how safe and effective Remicade biosimilars, such as Inflectra, are. Remicade and Inflectra act in very similar ways in the body. There aren’t any major differences in how they work.

A clinical study looked at people with Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, or plaque psoriasis. The people either switched from Remicade to Inflectra or kept taking Remicade. Inflectra helped control symptoms about as well Remicade.

A review article that included several clinical studies also found that switching from Remicade to biosimilars (such as Inflectra) provided similar symptom control.

However, current evidence of the long-term effectiveness of Remicade compared with its biosimilars is limited.

Costs

Remicade and Inflectra are both brand-name drugs. Remicade has four biosimilars: Avsola, Inflectra, Ixifi, and Renflexis. Inflectra is a biosimilar of Remicade.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

According to estimates on GoodRx.com, Remicade generally costs more than Inflectra per vial. The actual price you’ll pay for either drug depends on your dose, your location, and your insurance plan.

The Food and Drug Administration (FDA) approves prescription drugs such as Remicade to treat certain conditions. Remicade may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Approved uses for Remicade

Remicade is approved by the FDA to treat several autoimmune diseases (conditions in which your immune system attacks your body by mistake).

Remicade for Crohn’s disease

Crohn’s disease is a kind of inflammatory bowel disease (IBD) in which you have inflammation (swelling) in your digestive tract.

Remicade is FDA-approved to treat moderate to severe Crohn’s disease in adults as well as children ages 6 years and older. It’s approved for use when other commonly used medications haven’t eased Crohn’s disease symptoms well enough.

Remicade for ulcerative colitis

Ulcerative colitis is also a type of IBD, but you have inflammation in your colon (large intestine).

Remicade is FDA-approved to treat moderate to severe ulcerative colitis in adults as well as children ages 6 years and older. It’s approved for use when other conventional medications haven’t eased ulcerative colitis symptoms well enough.

Remicade for plaque psoriasis

Plaque psoriasis is a type of psoriasis in which red, itchy, red patches form on your skin.

Remicade is FDA-approved to treat chronic, severe plaque psoriasis in adults who:

• can take oral or injectable drugs that are systemic (work throughout the body)
• can’t take other conventional medications

Remicade for rheumatoid arthritis

With rheumatoid arthritis (RA), you have pain and inflammation in your joints and other body parts.

Remicade is FDA-approved to treat moderate to severe RA in adults. It’s used with the drug methotrexate.

Remicade for ankylosing spondylitis

Ankylosing spondylitis is a form of arthritis that mostly affects your spine.

Remicade is approved by the FDA to treat active ankylosing spondylitis in adults. “Active” means that you currently have symptoms.

Remicade for psoriatic arthritis

Psoriatic arthritis is a kind of joint swelling that can occur with the skin condition psoriasis.

Remicade is FDA-approved to treat active psoriatic arthritis in adults. “Active” means that you currently have symptoms.

Remicade effectiveness

Here are some examples of the effectiveness of Remicade in clinical studies:

• Crohn’s disease in adults. In a clinical study, adults with Crohn’s disease took Remicade. Between 39% and 46% of them were in disease remission (free from symptoms) after 30 weeks. In comparison, 25% of people who had one dose of Remicade followed by a placebo (treatment with no active drug) every 8 weeks had this result.
• Crohn’s disease in children. In a clinical study, children with Crohn’s disease took Remicade every 8 weeks or every 12 weeks. After 30 weeks of treatment, 60% of those who took Remicade every 8 weeks were free from symptoms. In comparison, 35% of children who took Remicade every 12 weeks had this response. Remicade wasn’t compared with a different drug or a placebo.
• Ulcerative colitis in adults. In clinical studies, people with ulcerative colitis took Remicade. Between 26% and 37% of them were free from symptoms after 30 weeks. In comparison, between 11% and 16% of people who took a placebo had this result.
• Ulcerative colitis in children. In a clinical study, children with ulcerative colitis took Remicade every 8 weeks or every 12 weeks. Of those who took Remicade every 8 weeks, 38% were free from symptoms after 54 weeks. Of those who took the drug every 12 weeks, 18% had this result. Remicade wasn’t compared with a different drug or a placebo.
• Rheumatoid arthritis. In a clinical study, people with rheumatoid arthritis took Remicade or a placebo. Both groups also took methotrexate. After 30 weeks, between 26% and 31% of the Remicade group saw a 50% improvement in symptoms. In comparison, 5% of people in the placebo group had this result.
• Ankylosing spondylitis. In a clinical study, people with ankylosing spondylitis took Remicade or a placebo. After 24 weeks, 44% of those who took Remicade saw their symptoms improve by at least 50%. In comparison, 9% of people who took a placebo had this result.
• Psoriatic arthritis. In a clinical study, people with psoriatic arthritis took Remicade or a placebo. After 6 months, 41% of those who took Remicade saw their symptoms improve by at least 50%. In comparison, 4% of people who took a placebo had this result.
• Plaque psoriasis. In clinical studies, people with plaque psoriasis took Remicade or placebo. After 10 weeks, 80% of those who took Remicade had no symptoms or minimal symptoms. In comparison, 4% of people who took a placebo had these results.

In many of these cases, people took other medications with Remicade. Examples of these drugs are methotrexate and corticosteroids, such as prednisone. How well Remicade works for you will depend on many factors. These include the symptoms of your disease, other health conditions you have, other medications you take, and your dose and treatment schedule.

Uses that are not approved

The FDA hasn’t approved Remicade to treat conditions other than the ones mentioned above. But sometimes the drug may be used off-label for other inflammatory diseases, which involve inflammation (swelling). Some of these conditions include:

Remicade for children

Remicade is approved by the FDA to treat children ages 6 years and older with moderate to severe Crohn’s disease or moderate to severe ulcerative colitis.

For information on the effectiveness of Remicade in treating these conditions, see the “Remicade effectiveness” section above.

It’s not known whether Remicade is safe to take during pregnancy. In animal studies, there was no harm to the developing baby when the mother took the drug. However, animal studies don’t always predict what will occur in humans.

You should only take Remicade during pregnancy if the benefits are greater than the risks.

If you’re pregnant or planning to become pregnant, talk with your doctor about whether Remicade is safe for you.

If you do take Remicade when you’re pregnant, your baby may have an increased risk for infection after birth. They shouldn’t get live vaccines for at least 6 months after they’re born to avoid serious infections.* A live vaccine contains a weakened form of a germ or virus. See the “Remicade and live vaccines” section below to learn more.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

It’s not known if Remicade is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Remicade.

It’s not known whether Remicade passes into breast milk. However, breastfeeding while taking Remicade isn’t recommended because of how severe the side effects of the drug can be.

If you’re breastfeeding and considering taking Remicade, talk with your doctor. They may recommend that you stop breastfeeding or delay treatment until you’re no longer breastfeeding.

Remicade is often used with other drugs in certain situations.

Combination therapy with methotrexate and other drugs

Your doctor may prescribe medication for you to take with Remicade to better control your symptoms. These drugs often ease inflammation (swelling) by treating different parts of your immune system than Remicade does.

For example, the American College of Gastroenterology recommends combination therapy for people with moderate to severe Crohn’s disease. The guidelines suggest using Remicade with medications such as azathioprine (Azasan, Imuran) or methotrexate (Otrexup, Rasuvo, RediTrex, Trexall, Xatmep). They also recommend taking corticosteroids, such as prednisone, with Remicade or other similar drugs.

Examples of other medications that may be used with Remicade to treat symptoms of rheumatoid arthritis (RA) include:

Examples of other medications that may be used with Remicade to treat symptoms of plaque psoriasis include:

• topical (treatment applied to the skin) corticosteroids, such as betamethasone (Beta-Val)
• topical calcipotriene (Dovonex, Enstilar, Sorilux)
• coal tar

Many of the conditions that Remicade treats can also be treated with similar additional medications. Talk with your doctor about the safety and effectiveness of all over-the-counter or prescription drugs you’re considering for your treatment.

Infusion reaction medications

Some people may have mild or moderate reactions during or shortly after receiving Remicade. Examples of possible symptoms include:

It’s common to take medications shortly before Remicade treatment to help prevent these reactions. These premedications include:

Remicade and alcohol don’t interact with each other.

While you take Remicade, it’s important to follow a healthy lifestyle. This helps your immune system work as well as possible.

Drinking too much alcohol can weaken your immune system. When your immune system isn’t strong enough to fight germs, you may be at risk for serious infections.*

Remicade has been linked to serious liver problems, which can lead to jaundice (yellowing of your skin and the white of your eyes). Drinking too much alcohol can damage your liver as well. So taking Remicade while drinking too much alcohol can increase your risk for liver problems.

If you take Remicade, talk with your doctor about whether drinking alcohol is safe for you.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Remicade can interact with several other medications. It can also interact with certain supplements and foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Remicade and other medications

Below is a list of medications that can interact with Remicade. This list doesn’t contain all drugs that may interact with Remicade.

Before taking Remicade, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Remicade with methotrexate

It’s not known exactly whether Remicade and methotrexate interact with each other. However, Remicade is prescribed with methotrexate for many autoimmune diseases (conditions in which your immune system attacks your body by mistake). These include rheumatoid arthritis (RA) and psoriatic arthritis.

In fact, taking methotrexate with Remicade may lower the risk of developing antibodies to Remicade. (Antibodies are immune system proteins that attack substances, such as Remicade, and can make them less effective.) Methotrexate may also increase how much Remicade circulates through your body. In both cases, Remicade may be more effective.

It’s also possible that taking Remicade with another medication that weakens your immune system could increase your risk for infections and cancer.* Your doctor will monitor you closely for infections and cancer if you take Remicade, with or without methotrexate.

* Remicade has boxed warnings for serious infections and cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Remicade and certain medications that weaken the immune system

Taking Remicade with certain biologic medications (drugs made from living organisms) can further weaken your immune system. This increases your risk for serious infections.*

Examples of medications that can weaken the immune system and shouldn’t be taken with Remicade include:

If you’re taking any of these medications, talk with your doctor before you start taking Remicade. They may recommend other treatment options.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Remicade and live vaccines

You shouldn’t receive live vaccines while taking Remicade. The drug decreases your immune system’s ability to fight infections.* So you may be at risk for the infection that the vaccine typically helps prevent.

Examples of live vaccines to avoid while taking Remicade include:

Before starting Remicade, make sure you’re up to date on all vaccines. If you need a live vaccine, get it before you start your Remicade treatment.

Live vaccines and babies

If you took Remicade while pregnant, your baby shouldn’t get live vaccines until they’re at least 6 months old. Babies exposed to Remicade before birth and who get vaccines too soon can have a higher risk for infections, serious complications, or death.

Here are some live vaccines that your baby shouldn’t receive for at least 6 months after birth:

If you have questions about what vaccines your baby needs and when they should have them, talk with your child’s doctor.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Remicade and warfarin

Taking Remicade with warfarin (Coumadin, Jantoven) may affect how quickly your body metabolizes (breaks down) warfarin. This could change how effective warfarin is at helping prevent blood clots. When you start or stop taking Remicade, your doctor will monitor your body’s response to warfarin. You may need a different dose of warfarin.

Remicade and theophylline

Taking Remicade with theophylline (Theocron, Theo-24, others) may affect how your body metabolizes (breaks down) theophylline. This could change how safe and effective theophylline will be. When you start or stop taking Remicade, your doctor will monitor your body’s response to theophylline. You may need a different dose of theophylline.

Remicade and cyclosporine

Taking Remicade with cyclosporine (Restasis, Sandimmune, others) may affect how your body metabolizes (breaks down) cyclosporine. This could change how safe and effective cyclosporine will be. When you start or stop taking Remicade, your doctor will monitor your body’s response to cyclosporine. You may need a different dose of cyclosporine.

Remicade and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Remicade, according to the drug’s manufacturer.

However, you should still check with your doctor or pharmacist before using any of these products while taking Remicade.

Remicade and foods

There aren’t any foods that have been specifically reported by the manufacturer that interact with Remicade. If you have any questions about eating certain foods with Remicade, talk with your doctor.

Remicade is used to treat certain autoimmune diseases. These are conditions in which your immune system mistakenly attacks your body’s own tissues or organs.

Remicade blocks the action of tumor necrosis factor-alpha (TNF-alpha). It’s an immune system protein in your body that’s involved in inflammation (swelling).

Most people with autoimmune diseases have higher-than-normal levels of TNF-alpha and too much inflammation. By blocking the activity of TNF-alpha, Remicade helps limit your immune system’s attack on healthy organs and body parts.

How long does it take to work?

Remicade starts to affect your immune system right away. But you may not see your symptoms improve for several days to weeks.

Here are answers to some frequently asked questions about Remicade.

Will I have withdrawal symptoms if I stop taking Remicade?

No, you won’t have actual withdrawal symptoms. But you may have more symptoms of your condition or they may worsen if you stop taking Remicade.

In a small study, researchers tested the outcomes of stopping Remicade treatment. They found that 72.1% of people needed medication to treat their condition after they stopped taking Remicade.

This study included people with Crohn’s disease. They were in clinical remission (free from symptoms) at the time they stopped using Remicade. People stayed symptom free for an average of 1 year after they stopped taking Remicade.

If you have questions about what to expect when your doctor ends your Remicade treatment, talk with them.

Is Remicade a form of chemotherapy?

No, Remicade isn’t a form of chemotherapy. Remicade is a biologic, which means it’s made from living organisms. Specifically, Remicade is monoclonal antibody that’s made from immune system cells in a lab. Monoclonal antibodies only block the activity of certain proteins in the body.

Chemotherapy, on the other hand, is a chemical drug that destroys rapidly growing cells throughout the body. It’s typically used to treat cancer. Chemotherapy medications affect many types of cells and organs. This is different from the very specific actions of monoclonal antibodies, such as Remicade.

Can Remicade cause cancer?

It’s not clear whether Remicade causes cancer.

There have been reports of new or unusual cancers* with the use of Remicade and other drugs in the tumor necrosis factor-alpha (TNF-alpha) blockers class. (A class of drugs is a group of medications that work in a similar way.)

Some of the cancers included lymphoma (cancer of the lymphatic system), skin cancer, and cervical cancer. Many of the cases occurred in younger males, with the exception of cervical cancer.

However, in a review of multiple studies, the evidence for cancer risk was conflicting. Analyses of studies and registries that collect information from larger populations have also had conflicting results.

If you have concerns about cancer, talk with your doctor about your medical history and your risk for cancer. They’ll explain the benefits and risks of taking Remicade. For more information about Remicade and cancer, see the “Remicade side effects” section above.

* Remicade has a boxed warning for cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Could Remicade stop working for me?

Yes. Remicade may become less effective for you over time. This can occur if your body’s immune system starts to recognize Remicade as a foreign invader and makes antibodies to Remicade. Antibodies are immune system proteins that fight foreign substances, including medications such as Remicade.

If your body makes anti-Remicade antibodies, the drug will clear from your system faster and won’t be as effective.

Remicade may also stop working for a time because of stress, dietary choices, or other health conditions.

If you’re concerned about how effective Remicade is in treating your condition, talk with your doctor.

Can I get vaccines while being treated with Remicade?

Yes and no. You can get inactive (not live) vaccines while taking Remicade. Inactive vaccines are made from germs that have been killed. Many of the vaccines that doctors recommend are inactive.

However, Remicade can weaken your immune system’s ability to fight infections.* So you shouldn’t get live vaccines during treatment. Live vaccines are made from weakened forms of germs. Examples of live vaccines to avoid while taking Remicade include the measles, mumps, and rubella (MMR) vaccine and the yellow fever vaccine. For more information, see the “Remicade interactions” section above.

Before you start taking Remicade, check with your doctor to see if you’re up to date on your vaccines.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Serious infections. People who take Remicade have an increased risk for serious infections that may lead to a hospital stay or death. These include tuberculosis (TB), fungal infections throughout the body, and other bacterial and viral infections. Before you start taking Remicade, your doctor will test you for TB and monitor you for it during your treatment. If you develop a serious infection while using Remicade, your doctor will have you stop taking the drug.

Cancers. Certain cancers, including lymphoma (cancer of the lymphatic system) and skin cancer, have been reported in people who took Remicade or other medications called tumor necrosis factor (TNF) blockers. (Remicade is a TNF blocker.) Some of the cases that occurred in children and teens were fatal.

One specific kind of lymphoma was hepatosplenic T-cell lymphoma. Most of the people who developed it were teenage or young adult males who had ulcerative colitis or Crohn’s disease. Nearly all of them were also taking a TNF blocker with the drugs azathioprine or 6-mercaptopurine.

Your doctor will screen you regularly for cancer during and after Remicade treatment.

Other precautions

Before taking Remicade, talk with your doctor about your health history. Remicade may not be right for you if you have certain medical conditions. These include:

• Current infections. Remicade can weaken your immune system, making it less able to fight germs. This can lead to serious infections. Talk with your doctor about any current or past infections you’ve had. If you have a history of certain infections, you may need to delay starting Remicade until the infection has been treated.
• Cancers. Cancers have been reported in people treated with Remicade. Tell your doctor if you’ve had cancer in the past. They can discuss the risks and benefits of Remicade treatment.
• Hepatitis B. Remicade can reactivate the hepatitis B virus if you were infected with the virus in the past. Your doctor will test you for hepatitis B before you start taking Remicade. If you test positive for hepatitis B, your doctor will monitor you closely for signs and symptoms of the virus during your Remicade treatment. You may require more treatment for hepatitis B.
• Liver damage. Severe liver damage has been reported in people who received Remicade. In certain cases, liver damage led to liver failure, liver transplant, and death. Talk with your doctor about any history of liver damage or liver disease you have. They’ll monitor you closely for signs and symptoms of worsening liver function during your Remicade treatment.
• Heart failure. People have had new or worsening heart failure while receiving Remicade. Certain doses of Remicade aren’t safe for people with moderate or severe heart failure. Tell your doctor if you have heart failure or a history of heart disease. They’ll discuss the risks and benefits of Remicade treatment.
• Blood disorders. Blood disorders, including low levels of white blood cells, have been reported with Remicade treatment. Some cases have led to death. Tell your doctor if you have a history of blood disorders. They’ll monitor you closely for signs and symptoms of worsening blood disorders while you receive Remicade.
• Serious infusion reactions. People have had serious cardiovascular (heart and blood vessel) or brain problems during or within hours of receiving a Remicade infusion. Examples of these problems include heart attack, stroke, low or high blood pressure, and abnormal heart rhythm (heartbeat that’s too fast, too slow, or irregular). Tell your doctor if you have a history of serious infusion reactions or cardiovascular or brain problems. They’ll monitor you closely during and after your infusions.
• Nervous system reactions. Some people have had new or worsening central nervous system disorders while taking Remicade. These include seizures and multiple sclerosis. Tell your doctor if you have a nervous system disorder or had one in the past. They’ll monitor you closely for new or worsening symptoms during your Remicade treatment.
• Allergic reaction. If you’ve had a severe allergic reaction to Remicade or any of its ingredients, you shouldn’t take Remicade. Ask your doctor what other treatments are better choices for you.
• Pregnancy. It’s not known whether Remicade is safe to take during pregnancy. For more information, please see the “Remicade and pregnancy” section above.
• Breastfeeding. Breastfeeding while taking Remicade isn’t recommended. For more information, please see the “Remicade and breastfeeding” section above.

Note: For more information about the potential negative effects of Remicade, see the “Remicade side effects” section above.

The following information is provided for clinicians and other healthcare professionals.

Indications

Remicade (infliximab) is FDA-approved to treat the following:

Administration

Remicade is administered by intravenous infusion.

Mechanism of action

Remicade is a monoclonal antibody that binds to tumor necrosis factor-alpha ligand and prevents it from binding to receptors. This results in decreased downstream immune system activation, including induction, migration, and activity of cytokines and immune system proteins and cells.

Pharmacokinetics and metabolism

Distribution is primarily in the vasculature. Metabolism is expected to occur via catabolism to smaller peptides and amino acids.

The median terminal half-life of Remicade is 7.7 to 9.5 days. There is no evidence of systemic accumulation following repeated doses, but clearance is increased in the presence of anti-infliximab antibodies.

Age, weight, and gender have no effect on clearance or volume of distribution.

Contraindications

Remicade in doses greater than 5 mg/kg is contraindicated for use in people with moderate to severe heart failure.

Remicade is also contraindicated in people with:

• a history of severe hypersensitivity reactions to the drug
• a history of hypersensitivity to any component of the drug or to murine proteins

Storage

Unopened vials of Remicade should be stored in the refrigerator at temperatures of 36°F to 46°F (2°C to 8°C).

Unopened vials may also be stored at room temperature (maximum of 86°F/30°C) for up to 6 months (but not exceeding the original expiration date). If storing vials at room temperature, the new expiration date should be written on the carton. Do not return the vials to the refrigerator.

Remicade vials do not contain preservatives.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Side effects, antibodies, cost, and more

Remicade is a brand-name prescription medication. It’s FDA-approved to treat certain autoimmune diseases in adults and children. These are conditions in which your immune system mistakenly attacks your body’s own tissues or organs. Conditions that Remicade is used to treat are:

Remicade is a treatment option for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, the drug is usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Remicade drug class and form

Remicade contains the drug infliximab, which is a biologic (a drug made from parts of living organisms). Remicade belongs to a drug class called tumor necrosis factor-alpha (TNF-alpha) blockers. A class of drugs is a group of medications that work in a similar way.

Remicade comes as a vial of powder that’s mixed with a liquid solution. The drug is available in one strength: 100 mg.

A healthcare provider will give you Remicade as an infusion. This is an injection into your vein that’s given over a period of time. Remicade infusions are typically about 2 hours long. You’ll usually receive an infusion every few weeks, but the timing depends on the condition that’s being treated.

Effectiveness

For information on the effectiveness of Remicade, please see the “Remicade uses” section below.

Remicade is available only as a brand-name medication. It contains the active drug ingredient infliximab.

The Food and Drug Administration (FDA) has approved four biosimilar versions of Remicade: Avsola, Inflectra, Ixifi, and Renflexis.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

Remicade can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Remicade. These lists don’t include all possible side effects.

For more information on the possible side effects of Remicade, talk with your doctor or pharmacist. They can also give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Remicade, you can do so through MedWatch.

More common side effects

The more common side effects of Remicade can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Remicade aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• New or worsening heart failure. Symptoms can include:
  • edema (swelling, typically in your ankles and feet)
• Heart attack. Symptoms can include:
  • lightheadedness or fainting
• Abnormal heart rhythms. Symptoms can include:
• Stroke. Symptoms can include:
  • weakness on one side of the body
  • trouble speaking or understanding others
  • trouble seeing in one or both of the eyes
  • trouble standing or walking
• Liver problems. Symptoms can include:
  • jaundice (yellowing of your skin and the white of your eyes)
  • pain on the right side of your belly
• Blood disorders, such as a low level of white blood cells. Symptoms can include:
  • bruising or bleeding easily
  • fever that lasts longer than 48 hours
• Nervous system disorders, such as seizures or vision problems. Symptoms can include:
  • numbness or tingling of body parts
  • weakness in your arms or legs
  • vision loss or changes in how you see color
• New or worsening psoriasis (a condition in which itchy, red patches form on your skin). Symptoms include:
  • scaly, red patches on skin
  • raised bumps on skin that are filled with pus
• Infusion reactions (symptoms or side effects that typically occur within 2 hours of your infusion). Symptoms can include:
  • chills (feeling cold for no reason)
• Certain cancers,* such as lymphomas (cancers of the lymphatic system). Symptoms can include:

Other serious side effects, explained in more detail below in “Side effect details,” include:

* Remicade has boxed warnings for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Side effects in children

In clinical studies, children with Crohn’s disease or ulcerative colitis had certain side effects more often than adults.

Side effects that occurred more often in children were:

• anemia (low level of red blood cells)
• low level of white blood cells
• flushing (warmth and redness in the skin)
• bacterial and viral infections
• bone fractures
• allergic reactions of the throat and lungs

Your doctor will monitor your child for these side effects during and after Remicade treatment.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, you may have an allergic reaction after taking Remicade. In clinical studies of people who took Remicade to treat rheumatoid arthritis (RA), at least 0.2% had an allergic reaction. Remicade wasn’t compared with a different drug or a placebo (treatment with no active drug.

In a study of children with Crohn’s disease, 6% of those who took Remicade had an allergic reaction that affected their lungs. Remicade wasn’t compared with a different drug or a placebo.

And in a study of adults with plaque psoriasis, 1% of people who took Remicade had a possible allergic reaction that occurred within 2 weeks after the infusion. Again, Remicade wasn’t compared with a different drug or a placebo.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

It’s also possible to have an allergic reaction after taking Remicade for a while. Or you may have an allergic reaction if you receive a Remicade infusion after a break in treatment. In addition to the usual allergic reaction symptoms, you may have:

• fever
• headache
• sore throat
• muscle and joint pain

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Remicade. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Long-term side effects

Side effects can occur if Remicade is taken over a long period time of time. These long-term side effects are similar to those seen in clinical studies.

In one long-term study, 23.3% of people who took Remicade had long-term side effects. This was compared with 11% of people who took a different TNF inhibitor. However, long-term side effects may vary depending on what condition you’re using the drug to treat and what other medications you’re taking with Remicade.

Safety concerns with long-term Remicade use include:

• increased risk of infections, such as TB or hepatitis B
• new or worsening heart failure or other heart problems, such as heart attack
• blood disorders, such as a low level of white blood cells
• liver problems, which can lead to jaundice
• nervous system disorders, such as seizures
• lupus-like syndrome (an immune system reaction)
• increased risk of certain cancers, such as lymphomas (cancers in the lymphatic system)

Some people treated with Remicade develop antibodies to the drug. These antibodies are immune system proteins that mistakenly attack the drug. If this occurs, Remicade may no longer work for you.

If you’re concerned about possible long-term side effects of Remicade, talk with your doctor.

Headache

Headache was one of the most common side effects seen in Remicade clinical studies. For example, 18% of people with RA who received Remicade had headaches. This was compared with 14% of people who took a placebo. Rates of headache may vary depending on what condition you’re using Remicade to treat.

Headache may also be a symptom of infusion reactions. These are symptoms or side effects that occur during or shortly after an infusion. Infusion reactions were one of the most common reasons that people stopped taking Remicade.

A headache may also be part of a delayed allergic reaction. This occurs several hours to days after an infusion.

A severe headache could be a sign of something more serious, such as a stroke. Other signs of a stroke include trouble walking or speaking, dizziness, or confusion.

If you have a headache that’s very painful or doesn’t improve with medication, call your doctor right away. If you feel like you’re having a medical emergency, call 911.

Rash

In a clinical study of people with RA, 10% of those who took Remicade had rashes. In comparison, rash occurred in 5% of people who took a placebo. Rates of rash may vary depending on what condition you’re using Remicade to treat.

Rash is also a symptom of infusion reactions. These are side effects or symptoms that occur during or shortly after an infusion.

In addition, rash is a common symptom of lupus-like syndrome, an immune system reaction that can occur during Remicade treatment.

If you develop a rash while taking Remicade, talk with your doctor about possible remedies. If the rash is mild, they may recommend topical medication (treatment applied to the skin). If the rash is more serious, they may want you to stop taking Remicade and switch to a different drug.

Fatigue

In clinical studies, 9% of people with RA who took Remicade had fatigue (lack of energy). In comparison, 7% of people who took a placebo had fatigue. Rates of fatigue may vary depending on what condition you’re using Remicade to treat.

Fatigue can also be a symptom of more serious Remicade side effects, such as infections or liver problems.

In addition, fatigue is a common symptom of many autoimmune diseases (conditions in which your immune system attacks your body by mistake). Fatigue may be caused by:

• inflammation (swelling)
• stress
• lack of sleep
• pain
• other factors

If fatigue is harming your quality of life while you take Remicade, talk with your doctor. They can suggest ways to boost your energy levels.

Joint pain

In clinical studies, 8% of people with RA who took Remicade had joint pain.

Joint pain was also a side effect of delayed reactions, along with muscle pain, fever, and rash.

In addition, joint pain was reported in people whose tuberculosis (TB) or hepatitis B reactivated (came back) or who developed a new case of lupus-like syndrome (an immune system reaction).

Remicade is used to treat conditions that have symptoms such as joint pain. So it may be hard to determine whether Remicade or the disease is causing the joint pain.

If you have new or worsening joint pain, talk with your doctor. They’ll check to see if there are other conditions that may be causing the pain. Your doctor can also recommend pain medication to help ease your discomfort.

Lupus

Lupus-like syndrome (an immune system reaction) has been reported in clinical studies of Remicade. Symptoms include:

• shortness of breath
• chest pain or discomfort
• joint pain
• rashes on arms or cheeks, which tend to get worse in sunlight

Some people have also had fever, weight loss, and malaise (feeling weak, tired, and simply not well). Rare but serious symptoms of lupus-like syndrome can include lung inflammation (swelling), nerve problems, and blood clots. Symptoms can occur within months to years of starting Remicade use.

It’s thought that Remicade causes a lupus-like syndrome because of the development of autoantibodies following treatment. Autoantibodies are immune system proteins made in your body. They mistakenly attack your own tissues or organs.

If you have lupus-like syndrome, your doctor may recommend that you stop taking Remicade. Symptoms usually go away within weeks to months after ending Remicade treatment.

Cancer/lymphoma

New cases of cancers* were reported in people who took Remicade in clinical trials and in people taking the drug after it was made available to the public. Cancer cases were also reported in people who took other drugs in the tumor necrosis factor-alpha (TNF-alpha) blocker class. This is the drug class that Remicade is in.

However, it’s not clear whether Remicade causes cancer.

Types of cancer

About half of the cancers were lymphomas (cancers in the lymphatic system). Cells in the lymph system usually fight off infections, but they can become cancerous. Types of lymphatic system cancers include Hodgkin lymphoma and non-Hodgkin lymphoma.

Other types of cancers reported were skin cancer, cervical cancer, breast cancer, colorectal cancer, and the rare hepatosplenic T-cell lymphoma.

People with chronic obstructive pulmonary disease (COPD) also had new cases of lung cancer, or head or neck cancer. Many cases of cancer occurred in children, teenagers, and young adults. Most of the new cancer cases occurred in people who were taking additional drugs that weakened their immune system.

The following people may be at greater risk for developing cancer when taking Remicade:

• those with COPD
• women older than age 60 years who have RA
• those with Crohn’s disease or ulcerative colitis and who are taking a TNF-alpha blocker as well as azathioprine or methotrexate
• those who have a very active autoimmune disease (a condition in which your immune system attacks your body by mistake) and have been treated for a long time

Statistics

In clinical trials of various conditions,** new lymphoma cancers occurred at a rate of 1 case for every 1,000 people who took Remicade for a year. This rate is about four times higher than is seen in the general population.

In clinical trials of various conditions,** new cases of cancer (excluding lymphoma and skin cancer) occurred at a rate of about 5 cases for every 1,000 people who took Remicade for a year. This rate is similar to what’s expected in the general population.

Remicade risk

Again, we don’t know whether Remicade actually causes cancer. A review of multiple studies found that the evidence of cancer risk was conflicting. Analyses of studies and registries that collect information from larger populations also have conflicting results.

If you have concerns about cancer, talk with your doctor about your medical history and your risk for cancer. They’ll explain the benefits and risks of taking Remicade.

* Remicade has a boxed warning for cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

** Rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis

Serious infections

Remicade can increase the risk of serious infections.* These infections include tuberculosis (TB), hepatitis B, fungal infections throughout the body, and other bacterial and viral infections.

In clinical trials of Remicade, 36% of people who took Remicade received treatment for an infection. This was compared with 25% of people who took a placebo. It’s not known how many people had an infection but didn’t receive treatment for it.

Serious infections occurred at lower rates, however. For example, in clinical studies of RA, 5.3% of people who took Remicade had a serious infection. This was compared to 3.4% of people who took a placebo. Both groups also took methotrexate.

In one clinical study of children with ulcerative colitis, 12% of those who took Remicade had a serious infection. Remicade wasn’t compared with a different drug or a placebo.

Symptoms of serious infections

Symptoms of serious infections can include:

• cough
• fever
• tiredness
• lack of appetite
• rash
• flu-like symptoms (such as a runny nose, chills, and muscle aches)

Your doctor will monitor you closely for symptoms of infection during and after Remicade treatment. You may need to be treated for an infection before you start to take Remicade. This is for cases in which you have an infection but don’t have symptoms yet.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Weight gain

Weight gain wasn’t a side effect reported in the initial clinical studies of Remicade.

However, it has been seen in some other studies:

• A small survey was conducted in people with various conditions who took tumor necrosis factor-alpha (TNF-alpha) drugs. This is the drug class that includes Remicade. (A drug class is a group of medications that work in a similar way.) The survey found that 13.3% of the people gained weight. The average weight gain was about 12 pounds (5.5 kilograms).
• In another small study, 68% of people with Crohn’s disease gained weight after taking Remicade for a year. Remicade wasn’t compared with a different drug or a placebo.
• And in a different small study of people with psoriasis, those treated with Remicade gained about 6 pounds (2.9 kilograms) on average. In comparison, no weight gain was reported in people who took the psoriasis drugs ustekinumab or secukinumab.

Very sudden weight gain may also be a sign of new or worsening heart failure.

If you’re concerned about weight gain, talk with your doctor about possible causes. They can suggest ways you can manage your weight.

Depression (not a side effect)

Depression wasn’t reported as a side effect in Remicade clinical studies. However, many people who have an autoimmune disease (a condition in which your immune system attacks your body by mistake) do have depression because of their disease. This depression may be caused by:

• inflammation (swelling)
• pain
• stress
• lack of sleep
• other factors

In clinical studies of people with inflammation conditions, such as psoriasis or Crohn’s disease, Remicade was found to be significantly more effective for easing depressive symptoms than a placebo. It’s not clear why, but a reduction in inflammation may have played a role.

If you think you might have depression, talk with your doctor. They can recommend treatments to help ease your symptoms.

Hair loss (not a side effect)

Hair loss wasn’t a side effect reported in clinical trials of Remicade.

In one study, about 3% of people had hair loss while taking tumor necrosis factor-alpha (TNF-alpha) medications. These drugs are in the same class as Remicade. (A drug class is a group of medications that work in a similar way.) The TNF-alpha drugs weren’t compared with a different drug or a placebo.

In another study, people who took Remicade had new or worsening cases of psoriasis. Symptoms can include itchy rashes or plaques (red, inflamed patches) on the scalp. These can lead to hair loss in that area. Plaques can also form on the arms or legs, which can lead to hair loss there, too.

It’s not known why Remicade causes psoriasis in some people because the Food and Drug Administration (FDA) has approved the drug to actually treat psoriasis.

In some cases, people’s hair started growing again after they stopped taking Remicade.

If your doctor wants you to keep using Remicade, topical treatments may help lessen hair loss due to psoriasis. (Topical treatments are applied to the skin.) If you have any concerns about hair loss, talk with your doctor.

Effects on teeth (not a side effect)

In clinical studies, people who took Remicade didn’t have any side effects related to teeth.

However, people taking Remicade are at an increased risk of infections. These can include infections that may occur following dental procedures.

If you’re taking Remicade, talk with your doctor and dentist. They can advise you on how to keep your mouth healthy and help prevent infections related to dental procedures.

Some people’s immune systems will develop antidrug antibodies to Remicade. Antibodies are immune system proteins that the body develops in response to foreign substances. Antibodies to Remicade will mistakenly attack the drug and clear it from your body more quickly.

Developing antibodies to Remicade can cause the drug to be less effective for you. It may also increase your risk of having a reaction to Remicade infusions. If you have a reaction, your doctor may recommend switching to a different medication.

In one study, researchers reviewed several clinical trials. They found that people who took Remicade had one of the highest rates of antidrug antibody formation. This was compared with people who took other biologic drugs for their conditions. (A biologic is made from parts of living organisms.)

If you’re taking higher doses of Remicade or taking Remicade with other drugs, you’re more likely to develop antibodies to Remicade.

If you have any questions about antibodies and Remicade, talk with your doctor.

As with all medications, the cost of Remicade can vary.

The actual price you’ll pay depends on your insurance coverage and your location.

Your insurance plan may require you to get prior authorization before approving coverage for Remicade. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Remicade.

If you’re not sure if you’ll need to get prior authorization for Remicade, contact your insurance company.

Financial assistance

If you need financial support to pay for Remicade, help is available. Janssen, the manufacturer of Remicade, offers a program called Janssen CarePath. For more information and to find out if you’re eligible for support, call 877-CarePath (877-227-3728) or visit the program website.

The Remicade dosage that your doctor prescribes will depend on several factors. These include:

• the condition you’re using Remicade to treat
• how much you weigh
• how well your body responds to Remicade treatment

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Remicade comes as a vial of powder, and each vial contains 100 mg of infliximab (the active drug in Remicade). Your healthcare provider will add a liquid to the vial to make a solution.

Then the healthcare provider will give you the Remicade solution as an infusion. This is an injection into your vein that’s given over a period of time.

Remicade infusions are typically about 2 hours long.

Dosage for FDA-approved indications

Your Remicade dosage will be based on your weight and the condition you’re taking Remicade for.

Remicade is given in two stages: an induction (beginning) stage and a maintenance stage.

In the induction stage, you’ll receive Remicade infusions at week 0, week 2, and week 6. After the induction stage, you’ll receive maintenance infusions every 6 or 8 weeks.

You may need higher doses or more frequent doses to help control your condition.

Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis

Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis have the same recommended dosing for adults. You’ll receive induction infusions of 5 mg/kg (5 mg/2.2 lb) at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 5 mg/kg every 8 weeks thereafter.

Here’s an example of how Remicade dosages are usually calculated: A 176-pound (80-kg) man taking Remicade for Crohn’s disease would receive a dose of about 400 mg in each infusion.

Rheumatoid arthritis

For rheumatoid arthritis (RA) in adults, the recommended dosing is induction infusions of 3 mg/kg (3 mg/2.2 lb) at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 3 mg/kg every 8 weeks thereafter.

Ankylosing spondylitis

For ankylosing spondylitis in adults, the recommended dosing is induction infusions of 5 mg/kg (5 mg/2.2 lb) at weeks 0, 2, and 6. Then you’ll have maintenance infusions of 5 mg/kg every 6 weeks thereafter.

Pediatric dosage

The Food and Drug Administration (FDA) has approved Remicade to treat children with Crohn’s disease or ulcerative colitis.

The dosage for children is the same as for adults. The induction (beginning) stage of dosing is 5 mg/kg (5 mg/2.2 lb) at weeks 0, 2, and 6. That’s followed by maintenance dosing of 5 mg/kg every 8 weeks.

What if I miss a dose?

It’s important to attend all your infusion visits. This gives you the best chance of improving your condition. If you regularly miss infusion appointments, your condition may worsen.

If you can’t make an appointment or forget to go, call your doctor’s office right away. The staff can reschedule your infusion. They may adjust the timing of your next visit based on when you had your most recent infusion.

When you make an appointment, write it down on a calendar. Or put a reminder on your phone so you can stay on track with your infusions.

Will I need to use this drug long term?

Remicade is meant to be used as a long-term treatment. If you and your doctor determine that Remicade is safe and effective for you, you’ll likely take it long term.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Remicade, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for moderate to severe Crohn’s disease

According to treatment guidelines, other drugs that may be used to treat Crohn’s disease include:

• oral corticosteroids, such as prednisone
• azathioprine (Azasan, Imuran)
• 6-mercaptopurine (Purinethol, Purixan)
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
• vedolizumab (Entyvio)
• natalizumab (Tysabri)
• ustekinumab (Stelara)

Alternatives for ulcerative colitis

According to treatment guidelines, other drugs that may be used to treat ulcerative colitis include:

• oral corticosteroids, such as prednisone

• mesalamine (Apriso, Asacol HD, Canasa, SfRowasa)
• balsalazide (Colazal, Giazo)
• olsalazine (Dipentum)
• rectal hydrocortisone (Cortifoam)
• azathioprine (Azasan, Imuran)
• 6-mercaptopurine (Purinethol, Purixan)

Alternatives for rheumatoid arthritis

According to treatment guidelines, other drugs that may be used to treat rheumatoid arthritis include:

• oral corticosteroids, such as prednisone
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• sulfasalazine (Azulfidine)
• hydroxychloroquine (Plaquenil)
• leflunomide (Arava)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
• golimumab (Simponi)
• certolizumab pegol (Cimzia)
• etanercept (Enbrel, Erelzi)
• abatacept (Orencia)
• tocilizumab (Actemra)

Alternatives for ankylosing spondylitis

According to treatment guidelines, other drugs may be used to treat ankylosing spondylitis. Some of these drugs are:

Alternatives for psoriatic arthritis

According to treatment guidelines, other drugs that may be used to psoriatic arthritis are:

• NSAIDS, such as naproxen (Aleve, Naprosyn) and celecoxib (Celebrex)
• oral or injectable corticosteroids, such as prednisone, methylprednisolone (Depo-Medrol, Medrol), hydrocortisone (Solu-Cortef)
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• sulfasalazine (Azulfidine)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)
• golimumab (Simponi)
• certolizumab pegol (Cimzia)
• etanercept (Enbrel, Erelzi)
• ustekinumab (Stelara)
• secukinumab (Cosentyx)
• abatacept (Orencia)

Alternatives for plaque psoriasis

According to treatment guidelines, other drugs that may be used to treat plaque psoriasis include:

• topical (treatment applied to the skin) corticosteroids
• topical vitamin D analogues, such as calcipotriene (Dovonex, Enstilar, Sorilux), calcitriol (Vectical)
• topical retinoids, such as tazarotene (Tazorac)
• topical coal tar
• methotrexate (Trexall, Rasuvo, Otrexup, others)
• etanercept (Enbrel, Erelzi)
• adalimumab (Humira, Amjevita, Cyltezo, Hyrimoz)

You may wonder how Remicade compares with other medications that are prescribed for similar uses. Here we look at how Remicade and Humira are alike and different.

Ingredients

Remicade contains the drug infliximab. Humira contains the drug adalimumab.

Uses

The Food and Drug Administration (FDA) has approved both Remicade and Humira to treat the following conditions:

Humira is also FDA-approved to treat:

Remicade and Humira are considered treatment options for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, the drugs are usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Drug forms and administration

Remicade comes as a vial of powder. Your healthcare provider will mix it with a liquid to make a solution. They will then give you the Remicade solution as an infusion. This is an injection into your vein that’s given over a period of time.

You’ll go to your doctor’s office or a clinic to have the infusions. Remicade infusions are typically around 2 hours long. The usual dosing schedule is once every 8 weeks after you complete the first stage of dosing.

Humira comes in three forms:

• a prefilled, single-dose syringe
• a prefilled, single-dose pen
• a single-dose vial for use only by a healthcare provider

Humira is given as an injection just under your skin (subcutaneous). A healthcare provider can give you the injections, or you can inject yourself at home. The usual dosing schedule is one injection every other week.

Side effects and risks

Remicade and Humira work in different ways but have some similar side effects. Examples of common and serious side effects for each drug are listed below.

People in both Remicade clinical studies and Humira clinical studies had side effects. But these may be symptoms of other side effects. For example, a fever may be a symptom of an infection. Side effects may overlap between the drugs.

More common side effects

Here are examples of more common side effects that can occur with Remicade, with Humira, or with both drugs (when taken individually).

• Can occur with Remicade:
• Can occur with Humira:
  • injection site reactions (redness, swelling, or pain where you had the injection)
  • rash
• Can occur with both Remicade and Humira:

Serious side effects

Here are examples of serious side effects that can occur with Remicade, with Humira, or with both drugs (when taken individually).

• Can occur with Remicade:
  • infusion reactions (side effects or symptoms that occur during or shortly after an infusion), such as rash
• Can occur with Humira:
  • few unique serious side effects
• Can occur with both Remicade and Humira:

* Remicade and Humira have boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information about Remicade’s boxed warnings, see “FDA warnings” at the beginning of this article.

Effectiveness

Remicade and Humira have different FDA-approved uses. But they’re both used to treat the following conditions:

• Crohn’s disease
• ulcerative colitis
• rheumatoid arthritis
• ankylosing spondylitis
• psoriatic arthritis
• plaque psoriasis

These drugs haven’t been directly compared in clinical studies, but studies have found both Remicade and Humira to be effective for treating the conditions mentioned above.

Costs

Remicade and Humira are both brand-name drugs. Biosimilars of both Remicade and Humira are FDA-approved.

• Remicade’s biosimilars are Inflectra, Ixifi, Avsola, and Renflexis.
• Humira’s biosimilars are Hadlima, Cyltezo, Hyrimoz, Abrilada, and Amjevita.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

The cost of Remicade and Humira depends on many factors, including the form used, the dosage, and the length of treatment. To learn more about cost for both drugs, visit GoodRx.

Like Humira (above), the drug Inflectra (infliximab-dyyb) has uses similar to those of Remicade. Here’s a comparison of how Remicade and Inflectra are alike and different.

Ingredients

Remicade contains the drug infliximab.

Inflectra contains infliximab-dyyb, a biosimilar of infliximab.

Biosimilars are biologic drugs made from living organisms. They are very similar to another medication (a reference drug) approved by the Food and Drug Administration (FDA).

Remicade is the reference drug for Inflectra. The “-dyyb” ending is added to the drug name to show that Remicade and Inflectra are two different products.

The FDA has reviewed how safe and effective biosimilars and their reference drugs are. The two medications act in very similar ways in the body. There aren’t any major differences in how they work. So the information for Remicade and its biosimilar Inflectra is alike.

Uses

Remicade and Inflectra are FDA-approved to treat people with the following conditions:

Remicade and Inflectra are considered treatment options for people whose disease is moderate to severe. For Crohn’s disease, ulcerative colitis, and plaque psoriasis, these drugs are usually prescribed for people who tried other medications that didn’t ease their symptoms. For more information on how Remicade is used, see the “Remicade uses” section below.

Drug forms and administration

Remicade and Inflectra both come as a vial of powder. Your healthcare provider will mix it with a liquid to make a solution.

Both drugs are given as an infusion. This is an injection into your vein that’s given over a period of time.

You’ll go to your doctor’s office or a clinic to have the infusions. Remicade and Inflectra infusions are usually about 2 hours long. The usual dosing schedule is once every 8 weeks after you complete the first stage of dosing.

Side effects and risks

Because Inflectra is a biosimilar of infliximab (the active drug in Remicade), Inflectra and Remicade have the same side effects. Examples of common and serious side effects for each drug are listed below.

More common side effects

This list contains more common side effects that can occur with both Remicade and Inflectra (when taken individually):

Serious side effects

Here are examples of serious side effects that can occur with Remicade and Inflectra (when taken individually):

* Remicade and Inflectra have boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information about Remicade’s boxed warnings, see “FDA warnings” at the beginning of this article.

Effectiveness

Remicade and Inflectra have the same FDA-approved uses.

The FDA has reviewed how safe and effective Remicade biosimilars, such as Inflectra, are. Remicade and Inflectra act in very similar ways in the body. There aren’t any major differences in how they work.

A clinical study looked at people with Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, or plaque psoriasis. The people either switched from Remicade to Inflectra or kept taking Remicade. Inflectra helped control symptoms about as well Remicade.

A review article that included several clinical studies also found that switching from Remicade to biosimilars (such as Inflectra) provided similar symptom control.

However, current evidence of the long-term effectiveness of Remicade compared with its biosimilars is limited.

Costs

Remicade and Inflectra are both brand-name drugs. Remicade has four biosimilars: Avsola, Inflectra, Ixifi, and Renflexis. Inflectra is a biosimilar of Remicade.

A biosimilar is a medication that’s similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

According to estimates on GoodRx.com, Remicade generally costs more than Inflectra per vial. The actual price you’ll pay for either drug depends on your dose, your location, and your insurance plan.

The Food and Drug Administration (FDA) approves prescription drugs such as Remicade to treat certain conditions. Remicade may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Approved uses for Remicade

Remicade is approved by the FDA to treat several autoimmune diseases (conditions in which your immune system attacks your body by mistake).

Remicade for Crohn’s disease

Crohn’s disease is a kind of inflammatory bowel disease (IBD) in which you have inflammation (swelling) in your digestive tract.

Remicade is FDA-approved to treat moderate to severe Crohn’s disease in adults as well as children ages 6 years and older. It’s approved for use when other commonly used medications haven’t eased Crohn’s disease symptoms well enough.

Remicade for ulcerative colitis

Ulcerative colitis is also a type of IBD, but you have inflammation in your colon (large intestine).

Remicade is FDA-approved to treat moderate to severe ulcerative colitis in adults as well as children ages 6 years and older. It’s approved for use when other conventional medications haven’t eased ulcerative colitis symptoms well enough.

Remicade for plaque psoriasis

Plaque psoriasis is a type of psoriasis in which red, itchy, red patches form on your skin.

Remicade is FDA-approved to treat chronic, severe plaque psoriasis in adults who:

• can take oral or injectable drugs that are systemic (work throughout the body)
• can’t take other conventional medications

Remicade for rheumatoid arthritis

With rheumatoid arthritis (RA), you have pain and inflammation in your joints and other body parts.

Remicade is FDA-approved to treat moderate to severe RA in adults. It’s used with the drug methotrexate.

Remicade for ankylosing spondylitis

Ankylosing spondylitis is a form of arthritis that mostly affects your spine.

Remicade is approved by the FDA to treat active ankylosing spondylitis in adults. “Active” means that you currently have symptoms.

Remicade for psoriatic arthritis

Psoriatic arthritis is a kind of joint swelling that can occur with the skin condition psoriasis.

Remicade is FDA-approved to treat active psoriatic arthritis in adults. “Active” means that you currently have symptoms.

Remicade effectiveness

Here are some examples of the effectiveness of Remicade in clinical studies:

• Crohn’s disease in adults. In a clinical study, adults with Crohn’s disease took Remicade. Between 39% and 46% of them were in disease remission (free from symptoms) after 30 weeks. In comparison, 25% of people who had one dose of Remicade followed by a placebo (treatment with no active drug) every 8 weeks had this result.
• Crohn’s disease in children. In a clinical study, children with Crohn’s disease took Remicade every 8 weeks or every 12 weeks. After 30 weeks of treatment, 60% of those who took Remicade every 8 weeks were free from symptoms. In comparison, 35% of children who took Remicade every 12 weeks had this response. Remicade wasn’t compared with a different drug or a placebo.
• Ulcerative colitis in adults. In clinical studies, people with ulcerative colitis took Remicade. Between 26% and 37% of them were free from symptoms after 30 weeks. In comparison, between 11% and 16% of people who took a placebo had this result.
• Ulcerative colitis in children. In a clinical study, children with ulcerative colitis took Remicade every 8 weeks or every 12 weeks. Of those who took Remicade every 8 weeks, 38% were free from symptoms after 54 weeks. Of those who took the drug every 12 weeks, 18% had this result. Remicade wasn’t compared with a different drug or a placebo.
• Rheumatoid arthritis. In a clinical study, people with rheumatoid arthritis took Remicade or a placebo. Both groups also took methotrexate. After 30 weeks, between 26% and 31% of the Remicade group saw a 50% improvement in symptoms. In comparison, 5% of people in the placebo group had this result.
• Ankylosing spondylitis. In a clinical study, people with ankylosing spondylitis took Remicade or a placebo. After 24 weeks, 44% of those who took Remicade saw their symptoms improve by at least 50%. In comparison, 9% of people who took a placebo had this result.
• Psoriatic arthritis. In a clinical study, people with psoriatic arthritis took Remicade or a placebo. After 6 months, 41% of those who took Remicade saw their symptoms improve by at least 50%. In comparison, 4% of people who took a placebo had this result.
• Plaque psoriasis. In clinical studies, people with plaque psoriasis took Remicade or placebo. After 10 weeks, 80% of those who took Remicade had no symptoms or minimal symptoms. In comparison, 4% of people who took a placebo had these results.

In many of these cases, people took other medications with Remicade. Examples of these drugs are methotrexate and corticosteroids, such as prednisone. How well Remicade works for you will depend on many factors. These include the symptoms of your disease, other health conditions you have, other medications you take, and your dose and treatment schedule.

Uses that are not approved

The FDA hasn’t approved Remicade to treat conditions other than the ones mentioned above. But sometimes the drug may be used off-label for other inflammatory diseases, which involve inflammation (swelling). Some of these conditions include:

Remicade for children

Remicade is approved by the FDA to treat children ages 6 years and older with moderate to severe Crohn’s disease or moderate to severe ulcerative colitis.

For information on the effectiveness of Remicade in treating these conditions, see the “Remicade effectiveness” section above.

It’s not known whether Remicade is safe to take during pregnancy. In animal studies, there was no harm to the developing baby when the mother took the drug. However, animal studies don’t always predict what will occur in humans.

You should only take Remicade during pregnancy if the benefits are greater than the risks.

If you’re pregnant or planning to become pregnant, talk with your doctor about whether Remicade is safe for you.

If you do take Remicade when you’re pregnant, your baby may have an increased risk for infection after birth. They shouldn’t get live vaccines for at least 6 months after they’re born to avoid serious infections.* A live vaccine contains a weakened form of a germ or virus. See the “Remicade and live vaccines” section below to learn more.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

It’s not known if Remicade is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Remicade.

It’s not known whether Remicade passes into breast milk. However, breastfeeding while taking Remicade isn’t recommended because of how severe the side effects of the drug can be.

If you’re breastfeeding and considering taking Remicade, talk with your doctor. They may recommend that you stop breastfeeding or delay treatment until you’re no longer breastfeeding.

Remicade is often used with other drugs in certain situations.

Combination therapy with methotrexate and other drugs

Your doctor may prescribe medication for you to take with Remicade to better control your symptoms. These drugs often ease inflammation (swelling) by treating different parts of your immune system than Remicade does.

For example, the American College of Gastroenterology recommends combination therapy for people with moderate to severe Crohn’s disease. The guidelines suggest using Remicade with medications such as azathioprine (Azasan, Imuran) or methotrexate (Otrexup, Rasuvo, RediTrex, Trexall, Xatmep). They also recommend taking corticosteroids, such as prednisone, with Remicade or other similar drugs.

Examples of other medications that may be used with Remicade to treat symptoms of rheumatoid arthritis (RA) include:

Examples of other medications that may be used with Remicade to treat symptoms of plaque psoriasis include:

• topical (treatment applied to the skin) corticosteroids, such as betamethasone (Beta-Val)
• topical calcipotriene (Dovonex, Enstilar, Sorilux)
• coal tar

Many of the conditions that Remicade treats can also be treated with similar additional medications. Talk with your doctor about the safety and effectiveness of all over-the-counter or prescription drugs you’re considering for your treatment.

Infusion reaction medications

Some people may have mild or moderate reactions during or shortly after receiving Remicade. Examples of possible symptoms include:

It’s common to take medications shortly before Remicade treatment to help prevent these reactions. These premedications include:

Remicade and alcohol don’t interact with each other.

While you take Remicade, it’s important to follow a healthy lifestyle. This helps your immune system work as well as possible.

Drinking too much alcohol can weaken your immune system. When your immune system isn’t strong enough to fight germs, you may be at risk for serious infections.*

Remicade has been linked to serious liver problems, which can lead to jaundice (yellowing of your skin and the white of your eyes). Drinking too much alcohol can damage your liver as well. So taking Remicade while drinking too much alcohol can increase your risk for liver problems.

If you take Remicade, talk with your doctor about whether drinking alcohol is safe for you.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Remicade can interact with several other medications. It can also interact with certain supplements and foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Remicade and other medications

Below is a list of medications that can interact with Remicade. This list doesn’t contain all drugs that may interact with Remicade.

Before taking Remicade, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Remicade with methotrexate

It’s not known exactly whether Remicade and methotrexate interact with each other. However, Remicade is prescribed with methotrexate for many autoimmune diseases (conditions in which your immune system attacks your body by mistake). These include rheumatoid arthritis (RA) and psoriatic arthritis.

In fact, taking methotrexate with Remicade may lower the risk of developing antibodies to Remicade. (Antibodies are immune system proteins that attack substances, such as Remicade, and can make them less effective.) Methotrexate may also increase how much Remicade circulates through your body. In both cases, Remicade may be more effective.

It’s also possible that taking Remicade with another medication that weakens your immune system could increase your risk for infections and cancer.* Your doctor will monitor you closely for infections and cancer if you take Remicade, with or without methotrexate.

* Remicade has boxed warnings for serious infections and cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Remicade and certain medications that weaken the immune system

Taking Remicade with certain biologic medications (drugs made from living organisms) can further weaken your immune system. This increases your risk for serious infections.*

Examples of medications that can weaken the immune system and shouldn’t be taken with Remicade include:

If you’re taking any of these medications, talk with your doctor before you start taking Remicade. They may recommend other treatment options.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Remicade and live vaccines

You shouldn’t receive live vaccines while taking Remicade. The drug decreases your immune system’s ability to fight infections.* So you may be at risk for the infection that the vaccine typically helps prevent.

Examples of live vaccines to avoid while taking Remicade include:

Before starting Remicade, make sure you’re up to date on all vaccines. If you need a live vaccine, get it before you start your Remicade treatment.

Live vaccines and babies

If you took Remicade while pregnant, your baby shouldn’t get live vaccines until they’re at least 6 months old. Babies exposed to Remicade before birth and who get vaccines too soon can have a higher risk for infections, serious complications, or death.

Here are some live vaccines that your baby shouldn’t receive for at least 6 months after birth:

If you have questions about what vaccines your baby needs and when they should have them, talk with your child’s doctor.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Remicade and warfarin

Taking Remicade with warfarin (Coumadin, Jantoven) may affect how quickly your body metabolizes (breaks down) warfarin. This could change how effective warfarin is at helping prevent blood clots. When you start or stop taking Remicade, your doctor will monitor your body’s response to warfarin. You may need a different dose of warfarin.

Remicade and theophylline

Taking Remicade with theophylline (Theocron, Theo-24, others) may affect how your body metabolizes (breaks down) theophylline. This could change how safe and effective theophylline will be. When you start or stop taking Remicade, your doctor will monitor your body’s response to theophylline. You may need a different dose of theophylline.

Remicade and cyclosporine

Taking Remicade with cyclosporine (Restasis, Sandimmune, others) may affect how your body metabolizes (breaks down) cyclosporine. This could change how safe and effective cyclosporine will be. When you start or stop taking Remicade, your doctor will monitor your body’s response to cyclosporine. You may need a different dose of cyclosporine.

Remicade and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Remicade, according to the drug’s manufacturer.

However, you should still check with your doctor or pharmacist before using any of these products while taking Remicade.

Remicade and foods

There aren’t any foods that have been specifically reported by the manufacturer that interact with Remicade. If you have any questions about eating certain foods with Remicade, talk with your doctor.

Remicade is used to treat certain autoimmune diseases. These are conditions in which your immune system mistakenly attacks your body’s own tissues or organs.

Remicade blocks the action of tumor necrosis factor-alpha (TNF-alpha). It’s an immune system protein in your body that’s involved in inflammation (swelling).

Most people with autoimmune diseases have higher-than-normal levels of TNF-alpha and too much inflammation. By blocking the activity of TNF-alpha, Remicade helps limit your immune system’s attack on healthy organs and body parts.

How long does it take to work?

Remicade starts to affect your immune system right away. But you may not see your symptoms improve for several days to weeks.

Here are answers to some frequently asked questions about Remicade.

Will I have withdrawal symptoms if I stop taking Remicade?

No, you won’t have actual withdrawal symptoms. But you may have more symptoms of your condition or they may worsen if you stop taking Remicade.

In a small study, researchers tested the outcomes of stopping Remicade treatment. They found that 72.1% of people needed medication to treat their condition after they stopped taking Remicade.

This study included people with Crohn’s disease. They were in clinical remission (free from symptoms) at the time they stopped using Remicade. People stayed symptom free for an average of 1 year after they stopped taking Remicade.

If you have questions about what to expect when your doctor ends your Remicade treatment, talk with them.

Is Remicade a form of chemotherapy?

No, Remicade isn’t a form of chemotherapy. Remicade is a biologic, which means it’s made from living organisms. Specifically, Remicade is monoclonal antibody that’s made from immune system cells in a lab. Monoclonal antibodies only block the activity of certain proteins in the body.

Chemotherapy, on the other hand, is a chemical drug that destroys rapidly growing cells throughout the body. It’s typically used to treat cancer. Chemotherapy medications affect many types of cells and organs. This is different from the very specific actions of monoclonal antibodies, such as Remicade.

Can Remicade cause cancer?

It’s not clear whether Remicade causes cancer.

There have been reports of new or unusual cancers* with the use of Remicade and other drugs in the tumor necrosis factor-alpha (TNF-alpha) blockers class. (A class of drugs is a group of medications that work in a similar way.)

Some of the cancers included lymphoma (cancer of the lymphatic system), skin cancer, and cervical cancer. Many of the cases occurred in younger males, with the exception of cervical cancer.

However, in a review of multiple studies, the evidence for cancer risk was conflicting. Analyses of studies and registries that collect information from larger populations have also had conflicting results.

If you have concerns about cancer, talk with your doctor about your medical history and your risk for cancer. They’ll explain the benefits and risks of taking Remicade. For more information about Remicade and cancer, see the “Remicade side effects” section above.

* Remicade has a boxed warning for cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Could Remicade stop working for me?

Yes. Remicade may become less effective for you over time. This can occur if your body’s immune system starts to recognize Remicade as a foreign invader and makes antibodies to Remicade. Antibodies are immune system proteins that fight foreign substances, including medications such as Remicade.

If your body makes anti-Remicade antibodies, the drug will clear from your system faster and won’t be as effective.

Remicade may also stop working for a time because of stress, dietary choices, or other health conditions.

If you’re concerned about how effective Remicade is in treating your condition, talk with your doctor.

Can I get vaccines while being treated with Remicade?

Yes and no. You can get inactive (not live) vaccines while taking Remicade. Inactive vaccines are made from germs that have been killed. Many of the vaccines that doctors recommend are inactive.

However, Remicade can weaken your immune system’s ability to fight infections.* So you shouldn’t get live vaccines during treatment. Live vaccines are made from weakened forms of germs. Examples of live vaccines to avoid while taking Remicade include the measles, mumps, and rubella (MMR) vaccine and the yellow fever vaccine. For more information, see the “Remicade interactions” section above.

Before you start taking Remicade, check with your doctor to see if you’re up to date on your vaccines.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Serious infections. People who take Remicade have an increased risk for serious infections that may lead to a hospital stay or death. These include tuberculosis (TB), fungal infections throughout the body, and other bacterial and viral infections. Before you start taking Remicade, your doctor will test you for TB and monitor you for it during your treatment. If you develop a serious infection while using Remicade, your doctor will have you stop taking the drug.

Cancers. Certain cancers, including lymphoma (cancer of the lymphatic system) and skin cancer, have been reported in people who took Remicade or other medications called tumor necrosis factor (TNF) blockers. (Remicade is a TNF blocker.) Some of the cases that occurred in children and teens were fatal.

One specific kind of lymphoma was hepatosplenic T-cell lymphoma. Most of the people who developed it were teenage or young adult males who had ulcerative colitis or Crohn’s disease. Nearly all of them were also taking a TNF blocker with the drugs azathioprine or 6-mercaptopurine.

Your doctor will screen you regularly for cancer during and after Remicade treatment.

Other precautions

Before taking Remicade, talk with your doctor about your health history. Remicade may not be right for you if you have certain medical conditions. These include:

• Current infections. Remicade can weaken your immune system, making it less able to fight germs. This can lead to serious infections. Talk with your doctor about any current or past infections you’ve had. If you have a history of certain infections, you may need to delay starting Remicade until the infection has been treated.
• Cancers. Cancers have been reported in people treated with Remicade. Tell your doctor if you’ve had cancer in the past. They can discuss the risks and benefits of Remicade treatment.
• Hepatitis B. Remicade can reactivate the hepatitis B virus if you were infected with the virus in the past. Your doctor will test you for hepatitis B before you start taking Remicade. If you test positive for hepatitis B, your doctor will monitor you closely for signs and symptoms of the virus during your Remicade treatment. You may require more treatment for hepatitis B.
• Liver damage. Severe liver damage has been reported in people who received Remicade. In certain cases, liver damage led to liver failure, liver transplant, and death. Talk with your doctor about any history of liver damage or liver disease you have. They’ll monitor you closely for signs and symptoms of worsening liver function during your Remicade treatment.
• Heart failure. People have had new or worsening heart failure while receiving Remicade. Certain doses of Remicade aren’t safe for people with moderate or severe heart failure. Tell your doctor if you have heart failure or a history of heart disease. They’ll discuss the risks and benefits of Remicade treatment.
• Blood disorders. Blood disorders, including low levels of white blood cells, have been reported with Remicade treatment. Some cases have led to death. Tell your doctor if you have a history of blood disorders. They’ll monitor you closely for signs and symptoms of worsening blood disorders while you receive Remicade.
• Serious infusion reactions. People have had serious cardiovascular (heart and blood vessel) or brain problems during or within hours of receiving a Remicade infusion. Examples of these problems include heart attack, stroke, low or high blood pressure, and abnormal heart rhythm (heartbeat that’s too fast, too slow, or irregular). Tell your doctor if you have a history of serious infusion reactions or cardiovascular or brain problems. They’ll monitor you closely during and after your infusions.
• Nervous system reactions. Some people have had new or worsening central nervous system disorders while taking Remicade. These include seizures and multiple sclerosis. Tell your doctor if you have a nervous system disorder or had one in the past. They’ll monitor you closely for new or worsening symptoms during your Remicade treatment.
• Allergic reaction. If you’ve had a severe allergic reaction to Remicade or any of its ingredients, you shouldn’t take Remicade. Ask your doctor what other treatments are better choices for you.
• Pregnancy. It’s not known whether Remicade is safe to take during pregnancy. For more information, please see the “Remicade and pregnancy” section above.
• Breastfeeding. Breastfeeding while taking Remicade isn’t recommended. For more information, please see the “Remicade and breastfeeding” section above.

Note: For more information about the potential negative effects of Remicade, see the “Remicade side effects” section above.

The following information is provided for clinicians and other healthcare professionals.

Indications

Remicade (infliximab) is FDA-approved to treat the following:

Administration

Remicade is administered by intravenous infusion.

Mechanism of action

Remicade is a monoclonal antibody that binds to tumor necrosis factor-alpha ligand and prevents it from binding to receptors. This results in decreased downstream immune system activation, including induction, migration, and activity of cytokines and immune system proteins and cells.

Pharmacokinetics and metabolism

Distribution is primarily in the vasculature. Metabolism is expected to occur via catabolism to smaller peptides and amino acids.

The median terminal half-life of Remicade is 7.7 to 9.5 days. There is no evidence of systemic accumulation following repeated doses, but clearance is increased in the presence of anti-infliximab antibodies.

Age, weight, and gender have no effect on clearance or volume of distribution.

Contraindications

Remicade in doses greater than 5 mg/kg is contraindicated for use in people with moderate to severe heart failure.

Remicade is also contraindicated in people with:

• a history of severe hypersensitivity reactions to the drug
• a history of hypersensitivity to any component of the drug or to murine proteins

Storage

Unopened vials of Remicade should be stored in the refrigerator at temperatures of 36°F to 46°F (2°C to 8°C).

Unopened vials may also be stored at room temperature (maximum of 86°F/30°C) for up to 6 months (but not exceeding the original expiration date). If storing vials at room temperature, the new expiration date should be written on the carton. Do not return the vials to the refrigerator.

Remicade vials do not contain preservatives.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Drug – Remicade 100mg – 1vial Injection (Infliximab) Price List or Cost of Medication

Drug information on Remicade (Infliximab) from Janssen Pharmaceutical

Drug Name : Infliximab

Infliximab(Remicade) generic Remicade is a monoclonal antibody, prescribed for autoimmune disorders, joint pain, Crohn’s disease, inflammatory bowel disease, ankylosing spondylitis, psoriasis. It blocks the action of TNF-alpha, a substance in the body that causes inflammation.

More Info about Infliximab

Other Trade Names for Infliximab

India : 

International : 

Remicade

Medindia currently has information on 3080 generic drugs and 110,061 brands that have their prices listed. New drugs with their prices are listed as and when they get approved by the drug controller. Please do write to us ([email protected]) if a drug is missing from our comprehensive drug price list.

Medical Condition(s) for which Remicade may be prescribed

Gastrointestinal:
Stomach pain, nausea, loss of appetite and blood in stool.

•  Heart:
Chest pain and shortness of breath.

•  Miscellaneous:

Headache, runny nose, vaginal itching, flushing, rash, joint pain and seizures.

It is administered intravenously in a dose of 5 mg/kg on day 1, second week, sixth week, and then after every 6 weeks.

It comes as a solution for injection to be administered by a healthcare provider into the vein.

Allergic to any components of the product, patients with moderate to severe heart failure should not receive more than 5 mg/kg.

• Avoid vaccination while taking this medication.

•Caution should be exercised in patients with history of hepatitis B.

•It may develop an active infection while using this medication.

It may affect blood clots, avoid unusual bruising or bleeding.

Store vials (powder for injection) in refrigerator (36° to 46°F). Do not freeze.

Inflectra may not be less expensive than Remicade in US / Research / Biosimilars / Home – GaBi Online

According to research carried out in the US, the cost of the infliximab biosimilar Inflectra (infliximab-dyyb) was only moderately less expensive than the originator biological Remicade (infliximab) in treating rheumatoid arthritis (RA) and exceeded US$14,000 annually under Medicare^# Part D*. In addition, out-of-pocket costs for patients taking Inflectra may be more than US$1,700 higher than for patients taking Remicade.

Prescribing biosimilar versions of biologicals is intended to reduce costs, but due to the complexity of Medicare’s cost-sharing structure it is difficult to determine whether this goal has been accomplished in many patient populations. For example, brand-name drugs and biologicals, but not biosimilars, are discounted during the coverage gap period that is triggered when a beneficiary’s total drug costs exceed a designated threshold. This will change in 2019, when biosimilars will receive the same 50% discount as biologicals, but patients’ out-of-pocket payments will still depend on whether they are treated the same or differently compared to biologicals in terms of pricing and plan cost-sharing requirements.

Author Yazdany and colleagues investigated the Medicare coverage and cost-sharing for Inflectra and Remicade from June 2017 to calculate out-of-pocket cost requirements and mean total cost for the two drugs. They found that, of 2,547 plans nationwide, only 10% covered the biosimilar, while 96% covered the originator biological. Inflectra had moderately lower costs over an 8-week prescription period, as well as on an annual basis (US$2,185 vs US$2,667 and US$14,202 vs US$17,335, respectively). However, all Part D plans required co-insurance cost-sharing similar to what was required with the originator infliximab. This led to projected out-of-pocket costs (without gap discounts) annually actually being higher, for Inflectra (US$5,118 per year) compared to Remicade (US$3,432 per year).

The authors concluded that although Inflectra was 18% less expensive than Remicade, it would cost patients US$1,700 more out of pocket. They also noted that, even with biosimilar gap discounts starting in 2019, Inflectra may still not significantly reduce out-of-pocket obligations for Part D beneficiaries due to its high price and co-insurance cost-sharing similar to Remicade. They pointed to the need for additional policies to address affordability and access to specialty drugs.

^#Medicare is a national social insurance program, administered by the US federal government since 1966. It provides health insurance for Americans aged 65 and older who have worked and paid into the system. It also provides health insurance to younger people with disabilities.

*Medicare Part D, also called the Medicare prescription drug benefit, is an optional US federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs through prescription drug insurance premiums.

Conflict of interest
The authors of the research paper [1] did not provide any conflict of interest statement.

Related articles
Real-life results for Inflectra compared to Remicade

Inflectra shows comparable results in IBD patients

Reference
1. Yazdany J, Dudley RA, Lin GA, et al. Out-of-pocket costs for infliximab and its biosimilar for rheumatoid arthritis under Medicare Part D. JAMA. 2018;320(9):931-3.

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Prescription Costs for Crohn’s Cause Sticker Shock

When I quit my full-time job to focus on my freelancing career earlier this year, I gave up a steady salary. Worse, though, I also gave up all the benefits that went along with it, including a terrific PPO health insurance plan that covered my Remicade infusions entirely with no out-of-pocket cost.

When I transitioned to coverage under my husband’s high-deductible health plan (HDHP), I knew there would be some changes to my coverage. But I was unaware of how drastic the difference would be financially, especially for the cost of my only two prescriptions: my anti-rejection medication tacrolimus for my liver transplant and Remicade (infliximab) for Crohn’s.

I was first hit with sticker shock when I had to refill my prescription for tacrolimus. Under my PPO, after meeting a $50 annual deductible for prescriptions, I only had a $10 copay. With the HDHP, the cost would be more than $450 a month until my husband and I met our total plan annual deductible of $3,500. My Remicade infusion was scheduled for a few weeks later and I could possibly meet our deductible with that alone. So I decided to pay the cash price of $151 instead of claiming my prescription on insurance to save money in the meantime.

Based on past insurance claims, I knew my provider charged around $4,700 per Remicade infusion. Because the price included both the medication and the infusion service, I was unsure how my new insurance would cover the claim. I was confused by the information I found online, so I called customer service to avoid getting blindsided by having to pay anything at my appointment.

I wasn’t very confident with the insurance rep’s quote of a $70 office visit copay for the infusion, so I contacted my doctor’s billing office. The billing representative wanted to confirm her answer with her manager and told me she would have the manager call me back. The billing manager never called before my appointment, and the infusion nurses didn’t have instructions to collect payment from me. They told me not to worry until I received a bill. A couple of weeks later, I did.

Based on the $2,900+ bill, I finally understood that insurance wouldn’t cover any of the cost for the infusion until we met the deductible. Because we had already paid a portion of the deductible for the year, the infusion pushed us so far over the $3,500 amount that I only had a 10 percent copay for some of the charges.

Our health savings account (HSA) only had about $600 in it, and I immediately deposited $3,000 into it to pay for the bill. A couple of days after I made the deposit, I received a call from my doctor’s billing office. I was expecting the representative to ask for full payment, but instead she asked if I was enrolled in the Janssen CarePath program to help pay for the Remicade.

CarePath provides resources and financial assistance for patients who are prescribed one of the many Janssen medications, including Remicade and Stelera (ustekinumab), and who meet certain criteria. First of all, the patient’s healthcare provider must participate in the program. As a registered provider, doctors are assigned a care coordinator who can assist with reviewing patients’ healthcare coverage, billing and reimbursement, and coordination with specialty pharmacies and infusion centers.

Patients can then enroll in the program if they have commercial or private health insurance. Individuals receiving Medicare, Medicaid, or some other form of government-funded health programs, and those who lack any coverage are ineligible for assistance, but CarePath provides information to help them find other resources for help.

Reimbursement varies by medication, so I can only speak about my experience with Remicade. Under the program, patients pay $5 for the cost of the medication and CarePath pays the remainder with an annual maximum benefit of $20,000. Only the prescription costs are covered, so the patient is responsible for all other infusion-related costs. For me, more than 92 percent of my bill was for Remicade; thus, the savings I received was tremendous.

As an added benefit, the CarePath payment applied toward my insurance deductible. Technically, CarePath covered almost our entire deductible for 2019, saving us close to $3,000 of healthcare expenses. Savings vary depending on individual plan copays, deductibles and coinsurance payments. However, any savings is worth the 15 minutes or so it takes to enroll in the program.

I just had my second Remicade infusion under the program and am still waiting for the bill from my provider. Although I am not sure how much I will owe this time, now that I’ve met my deductible and have CarePath, I’m not worried about breaking the bank.

***

Note: IBD News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health providers with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of IBD News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to IBD.

Emmeline is a 47-year-old Crohn’s warrior and primary sclerosing cholangitis survivor. Her column encourages patients and caregivers to advocate for better healthcare and educates readers about her rare autoimmune diseases. She also freelances as a communication specialist, offering writing, editing, and graphic design services. Emmeline (an Auburn fan) and her husband Patrick (an Alabama fan) enjoy watching SEC football and spending time with loved ones in Austin, Texas. Thanks to a liver transplant in 2017, Emmeline is training for her third-degree black belt in the Korean martial art Mu Sool Won.

Inflectra, a Remicade Biosimilar, Now Available Through Medicare and Medicaid

Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), is now covered by Medicare and Medicaid. Approved by the Food and Drug Administration in April 2016, Inflectra is the first biosimilar indicated for the treatment of rheumatic and inflammatory diseases to come to market in the United States. The Centers for Medicare and Medicaid Services added it to its pricing list beginning January 1, 2017.

“That means the drug is readily available,” explains Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, in Fargo.

A biosimilar is a highly similar, but not quite identical, copy of an already approved biologic drug, called the reference product or the originator drug. To be approved, a biosimilar must have no clinically meaningful difference from the reference product in terms of safety, efficacy or mode of administration – but biosimilars are expected to cost less. Two other biosimilars – Amjevita, a biosimilar to Humira, and Erelzi, a biosimilar to Enbrel – have also been FDA-approved, but neither is available because of pending patent litigation.

Inflectra became available to patients on November 21 in what is considered an “at-risk” launch – drug-maker Pfizer decided to release it despite unsettled patent issues with Remicade drug-maker Johnson & Johnson. Inflectra, an intravenous infusion like Remicade, is approved for the same conditions as its originator drug: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

Jonathan Kay, MD, professor of medicine at University of Massachusetts Medical School in Worcester and an expert on biosimilars, says he sees biosimilars as a welcome option for his patients and discusses the newly-available medication with them during follow-up visits.

“Patients can be reassured these aren’t knockoffs; rather they are carefully crafted replicas that have undergone rigorously testing,” Dr. Kay says. “My patients aren’t nervous about being treated with a biosimilar because I explain to them the data that show them to be highly similar. Patients are excited about the availability of a drug that will allow them the same treatment but at a lower cost.”

While some people may be reluctant to switch drugs if their disease is stable on their current medication, it’s expected that the lower cost may lure others to switch to or to start out with a biosimilar. Pfizer says Inflectra is being sold at 15 percent lower cost than Remicade – not including insurance and other discounts. But since biologics can cost thousands of dollars per dose, and other factors, such as insurance plans, come into play, some experts don’t think that’s enough of a difference.

“Fifteen percent will not be meaningful for most patients since actual savings to patients will depend on how their insurance is structured, fixed co-pay amounts, cost-sharing, etc.,” says Miller. “I don’t think the 15 percent will be enough to drive many rheumatologists to specifically prescribe Inflectra.”

The pricing of a drug is complicated and depends on a number of factors, including how insurance companies classify medications. Patients should check with their own insurance providers to understand the specific implications for them based on what their Pharmacy Benefit Managers (PBM) – the third-party companies that handle prescription drug programs for health plans – are doing. For example, the largest PBM, Express Scripts, began offering Inflectra in December, giving it the same formulary status as Remicade.

Still, some doctors say getting Inflectra on the market and onto insurers’ drug lists are important steps for biosimilars. Dr. Kay notes that in some countries, such as South Korea, competition from biosimilars has driven down prices of the originator drugs, which ultimately leads to more choices for patients.

Biosimilars were made possible by the Affordable Care Act (ACA), which created a special pathway for their approval. If the ACA (Obamacare) is repealed, Dr. Kay says it remains to be seen what will happen to the biosimilar pathway. He says he hopes lawmakers will pass other legislation to preserve this important route to keeping effective therapies reasonably priced.

Author: Jennifer Davis for the Arthritis Foundation

Related Resources:

Remicade instructions for use: indications, contraindications, side effects – description Remicade lyophilisate for prigot. solution for inf. 100 mg: fl. 1 PC. (37257)

From the nervous system: often – headache, dizziness, fatigue; rarely – depression, psychosis, anxiety, amnesia, apathy, nervousness, drowsiness.

From the digestive system: often – nausea, diarrhea, abdominal pain, dyspepsia; rarely – constipation, gastroesophageal reflux, cheilitis, diverticulitis, liver dysfunction, cholecystitis.

From the hematopoietic system: rarely – anemia, leukopenia, lymphadenopathy, lymphocytosis, lymphopenia, neutropenia, thrombocytopenia.

From the cardiovascular system: often – hot flashes, chest pain; rarely – arterial hypertension, arterial hypotension, fainting, thrombophlebitis, bradycardia, palpitations, vasospasm, cyanosis, impaired peripheral circulation, arrhythmia, edema.

Respiratory system: often – shortness of breath, viral infection (flu, herpes), fever, upper respiratory tract infections, bronchitis, pneumonia; rarely – bronchospasm, pleurisy, pulmonary edema.

From the side of the organ of vision: rarely – conjunctivitis, keratoconjunctivitis, endophthalmitis.

From the urinary system: rarely – urinary tract infections, pyelonephritis.

From the side of the blood coagulation system: rarely – ecchymosis / hematoma, petechiae, epistaxis.

Dermatological reactions: often – rash, skin rash, itching, urticaria, sweating, dry skin; rarely – fungal dermatitis (onychomycosis, eczema), seborrhea, erysipelas, warts, furunculosis, periorbital edema, hyperkeratosis, skin pigmentation disorders, alopecia, bullous rash.

Allergic reactions: urticaria, itching, swelling of the face, lips, hands, myalgia and / or arthralgia with fever, formation of autoantibodies, lupus syndrome.

Others: often – fever; rarely – abscesses, cellulitis, sepsis, bacterial and fungal infections, myalgia, arthralgia, vaginitis, infusion syndrome, reaction at the injection site.

Remicade :: Instruction :: Price :: Description of the drug

Remicade
1 bottle of Remicade contains:
Infliximab – 100 mg;
Additional substances.
Remicade is a drug with an immunosuppressive effect. Remicade contains the active component infliximab, which is a hybrid mouse-human monoclonal antibodies with high affinity that bind soluble and transmembrane forms of TNFa (tumor necrosis factor a). Infliximab rapidly forms stable complexes with human TNFa, thus decreasing its biological activity. Remicade has a specific effect on TNFa, without affecting lymphotoxin a.
In patients with rheumatoid arthritis, there is an increase in the level of TNFa in the joints, while the level of TNFa increases with an exacerbation of the disease. When using the drug Remicade in patients with rheumatoid arthritis, there was a decrease in infiltration in the area of ​​inflamed joints, a decrease in the expression of molecules that promote cell adhesion of chemoatraction and tissue degradation. In addition, with the use of infliximab in patients, there was a decrease in the level of C-reactive protein and interleukin 6 (IL-6) in plasma and an increase in the level of hemoglobin.

In patients with psoriasis, Remicade led to a decrease in epidermal inflammation and normalization of keratinocyte differentiation in psoriatic plaques. In psoriatic arthritis, short-term use of the drug Remicade led to a decrease in the level of T cells and blood vessels in the psoriatic skin and synovium.
Histological evaluation of colon specimens obtained before the initiation of therapy and 4 weeks after the initiation of infliximab therapy showed a significant decrease in TNFa levels.In addition, in patients with Crohn’s disease, there was a decrease in the level of C-reactive protein, normalization of the level of lymphocytes, neutrophils and monocytes during therapy with Remicade.
The use of Remicade in such patients also led to a decrease in the number of cells capable of expressing interferons and TNFa, a decrease in the severity of infiltration of inflammatory cells and the presence of inflammatory markers in the affected areas. Endoscopic examination showed healing of the intestinal mucosa in patients who received infliximab therapy.

With intravenous administration of the drug Remicade, plasma concentrations were proportional to the dose. Infliximab is distributed primarily in the vascular bed. The elimination pathway for infliximab has not been established.
There were no clinically significant differences in pharmacokinetics in patients of different groups, including groups divided by age and sex, renal and liver function.
The average half-life of infliximab with the introduction of 3.5 and 10 mg / kg body weight was 8-9.5 days. In this case, the active component of the drug Remicade in most patients was determined in plasma 8 weeks after a single administration.
With three administrations, there is some accumulation of infliximab, which has no clinical significance.
In children with Crohn’s disease, the pharmacokinetics of Remicade was similar to that in adults.

Remicade is recommended to be prescribed in combination with methotrexate or as monotherapy (for patients for whom methotrexate therapy is contraindicated).
Remicade is used to reduce symptoms and increase physical functionality in patients with rheumatoid arthritis.In particular, Remicade is prescribed to adults with active rheumatoid arthritis, in whom basic antirheumatic drugs are ineffective, as well as adults with severe, progressive or active rheumatoid arthritis who have not previously received methotrexate and other basic antirheumatic drugs (in these patients, Remicade leads to a slowdown in progression diseases).

Remicade is prescribed for adult patients suffering from a severe active form of Crohn’s disease, who do not respond to therapy with corticosteroids and / or immunosuppressants, or these drugs are contraindicated.In addition, Remicade is prescribed for adult patients with active Crohn’s disease, which is accompanied by the formation of fistulas (provided that the first-line drugs recommended in such cases are ineffective).
Remicade is used to treat children over 6 years of age with active severe Crohn’s disease who do not respond to standard therapy (corticosteroids, diet, immunosuppressants) or are contraindicated in this therapy. In such cases, Remicade should be prescribed only in combination with standard immunosuppressive therapy.

The drug Remicade is prescribed for adults with an active form of ulcerative colitis (with moderate and severe course of the disease), with intolerance or ineffectiveness of standard treatment regimens.
Remicade is prescribed for patients with active and progressive form of ankylosing spondylitis and psoriatic arthritis in whom standard therapy is not effective enough.
Remicade can be used for the treatment of plaque psoriasis (moderate to severe and severe) in the absence of a response to standard therapy or in the impossibility of prescribing such (if there are contraindications).

Remicade should be prescribed by a physician experienced in the treatment of the relevant conditions.
Lyophilisate Remicade is intended for the preparation of a solution for infusion (intravenous drip). The infusion should be carried out in a hospital under the supervision of medical personnel (monitoring of the patient’s condition should be continued for at least 2 hours after the end of the infusion). In the institution where the treatment with Remicade is carried out, there must be resuscitation and ambulance drugs.Patients should be informed about possible side effects, as well as the scheme of action if they develop.

Dosage of Remicade:
Duration of use and dose of Remicade is determined by the doctor.
Patients with rheumatoid arthritis who have not previously used Remicade are usually prescribed infliximab at a dose of 3 mg / kg body weight in the form of a 2-hour infusion. The infusion of infliximab at the same dose is repeated at 2 and 6 weeks of therapy, after which Remicade is administered at the same dose every 8 weeks.With good tolerance of the first infusion, in the future, you can reduce the time of administration of the drug Remicade to 60 minutes (with the same dose).
The therapeutic effect usually develops 12 weeks after the start of treatment; in the absence of positive dynamics, the dose should be revised. It is allowed to gradually increase the dose of infliximab to 7.5 mg / kg body weight 1 time in 8 weeks or reduce the intervals between injections to 1 time in 4 weeks while maintaining a single dose of 3 mg / kg body weight. After the desired effect is achieved, the therapy regimen and infliximab dose are not changed.

For active severe Crohn’s disease (including the formation of fistulas), ulcerative colitis, ankylosing spondylitis, psoriasis and psoriatic arthritis, a single infliximab dose of 5 mg / kg of body weight (in the form of a 2-hour infusion) is prescribed. Re-infusion is carried out after 2 weeks, keeping a single dose. If there is a positive reaction to therapy, Remicade is administered in the same single dose at 6 weeks of treatment, after which Remicade is administered every 8 weeks. If a positive response to the drug disappears during therapy, it makes sense to consider increasing the dose of infliximab.
In patients with Crohn’s disease, ulcerative colitis and ankylosing spondylitis in the absence of a response to treatment after 2-3 infusions, Remicade is discontinued.
In patients with psoriasis who do not respond to treatment after 4 infusions, Remicade is discontinued.
In case of interruption of maintenance therapy for Crohn’s disease and rheumatoid arthritis, it is effective to administer an appropriate single dose after a break of not more than 16 weeks. If maintenance therapy is interrupted and Remicade is administered with an interval of 16-20 weeks after the last infusion, the risk of side effects increases and the effectiveness of infliximab decreases.
Reuse of the drug Remicade after discontinuation of maintenance therapy for various indications has not been adequately studied.

For children over 6 years of age with Crohn’s disease, Remicade is prescribed according to the same scheme as for adults with a single dose of 5 mg / kg of body weight (after the first injection, the infusion is carried out at 2 and 6 weeks, after which they switch to the introduction once every 8 weeks) …
In children under 6 years of age, the use of Remicade has not been studied.

Route of administration of the drug Remicade:
The drug should be administered intravenously slowly by drip (the minimum time of the first infusion is 2 hours, starting from the fourth infusion, if patients with rheumatoid arthritis are well tolerated, the administration time can be reduced to 1 hour).To reduce the risk of side effects, the infusion time may be increased.
Preparation and administration of the solution should take place under aseptic conditions; during infusion, a system with a pyrogen-free filter with a low protein binding capacity should be used.
To prepare an infusion solution, the required dose should be calculated, taking into account that 1 bottle contains 100 mg of infliximab, as well as the volume of the dissolved drug. The contents of each vial are dissolved in 10 ml of water for injection using a syringe with a needle of 0.8 mm or less.Before injecting the solvent, remove the cap and wipe the cap with an antiseptic.

The needle of the syringe is inserted into the vial through the center of the rubber stopper and water is injected along the wall of the vial. Gently scrolling the bottle, the powder is dissolved, left for 5 minutes, drawn into a syringe and dissolved in an infusion solution of 0.9% sodium chloride to 250 ml. To obtain the exact volume, a volume equal to the volume of the resulting Remicade solution (in water for injection) is taken from the vial with the infusion solution with a syringe, after which the Remicade solution is slowly injected into the vial with the infusion preparation and carefully dissolved.
Do not shake the bottle when dissolving the powder, otherwise foam will form. It is forbidden to use the drug Remicade in case of formation of visible insoluble particles in the solution or a significant change in color (the Remicade solution must be transparent and colorless or slightly yellow in color).
Remicade does not contain preservatives, it is forbidden to store the ready-made solution. The Remicade infusion should be administered within 3 hours after its preparation, the rest of the infusion is disposed of.
It is forbidden to administer the drug Remicade through the same system with other drugs.

When using the drug Remicade, patients experienced the development of side effects associated with infusion, including shortness of breath, shortness of breath, headache and urticaria, which could require discontinuation of the drug.

In addition, the use of infliximab may develop such an undesirable effect:
On the blood system: leukopenia, lymphocytosis, lymphadenopathy, anemia, lymphopenia, thrombocytopenia, thrombocytopenic thrombohemolytic purpura, agranulocytosis, neutropenia.It is also possible to develop hemolytic anemia, idiopathic thrombocytopenic purpura and pancytopenia.
On the nervous system: depression, anxiety, confusion, apathy, memory impairment, nervousness, disturbances in sleep and wakefulness. In addition, the development of headache, exacerbation of multiple sclerosis, dizziness and meningitis is possible.

Sensory organs: endophthalmitis, keratoconjunctivitis, conjunctivitis, periorbital edema.
On the heart and blood vessels: hot flashes, bradycardia, syncope, cyanosis, palpitations, cardiac arrhythmias, deterioration in patients with heart failure, arterial hypertension, hematoma / ecchymosis, fever.In addition, it is possible to develop arterial hypotension, vascular spasm, thrombophlebitis, petechiae, peripheral circulatory disorders, tachycardia and vascular insufficiency, as well as ischemia and myocardial infarction, pericardial effusion and heart failure.
Respiratory system: lower and upper respiratory tract infections, shortness of breath, sinusitis, pleural effusion, interstitial lung disease.

On the digestive tract: epigastric pain, stool disorders, vomiting, nausea, dyspeptic symptoms, gastroesophageal reflux, diverticulitis, intestinal stenosis and perforation, pancreatitis, gastrointestinal bleeding.
On the liver and biliary tract: liver dysfunctions, hepatitis, cholecystitis, increased activity of liver enzymes, autoimmune hepatitis, jaundice, hepatocellular disorders.
On the musculoskeletal system: pain in the back, muscles and joints.
On the urinary system: pyelonephritis, urinary tract infections.
On the skin: urticaria, onychomycosis, fungal skin lesions, rosacea, hyperkeratosis, warts, furunculosis, pigmentation disorders, alopecia.

Allergic reactions: symptoms similar to serum sickness, lupus-like syndrome, allergic rhinitis, cough, angioedema, anaphylactic shock.In addition, it is possible to develop vasculitis, sarcoid reaction and serum sickness, as well as Lyell’s syndrome, Stevens-Johnson syndrome and psoriasis.
Development of infections and invasions during therapy with infliximab: influenza, herpes, bacterial infections, tuberculosis, candidal lesions of the mucous membranes and skin, opportunistic infections (including pneumocystosis, aspergillosis, cryptococcosis, histoplasmosis, coccidioidomycosis and blastomycosis, and cystomycosis, as well as ), parasitic infections, reactivation of hepatitis B.
Development of benign and malignant, as well as non-specific tumors: lymphoma, hepatolienal T-cell lymphoma, non-Hodgkin’s lymphoma, leukemia, Hodgkin’s disease.

Other side effects: vaginitis, excessive sweating, chest pain, pyrexia, pain and swelling at the injection site, the appearance of antibodies, changes in the complement factor.
If side effects develop, it is necessary to examine the attending physician and assess the severity of side effects (based on these data, the doctor decides whether to continue therapy with Remicade).

Remicade is not prescribed to patients with a history of intolerance to infliximab or additional components of the lyophilisate, as well as other mouse proteins.
Remicade is not prescribed for patients suffering from severe forms of infectious diseases, including sepsis, tuberculosis (before starting treatment, tuberculosis, including latent tuberculosis must be excluded), opportunistic infections and abscesses.
The drug Remicade is contraindicated in severe or moderately severe heart failure.
In pediatrics, it is allowed to use the drug Remicade for the treatment of children over 6 years old with Crohn’s disease.
Remicade should be used with caution in patients with a history of severe chronic or recurrent infections, as well as in patients who live or travel in regions where fungal infections are endemic.

You should not vaccinate with live vaccines during the period of therapy with Remicade.
Infliximab should be used with caution in patients with a history of demyelinating disorders, as well as in patients with a family history of autoimmune diseases.
Remicade is prescribed with caution to patients with chronic obstructive pulmonary disease (due to a higher risk of developing tumors), mild heart failure, hepatitis B carriage and risk factors for hematopoietic disorders.
There is no data on the effect of Remicade on surgical interventions, caution should be exercised when performing surgical interventions in patients receiving infliximab.
There are no data on the use of Remicade in patients with impaired renal and hepatic function; caution should be exercised when prescribing infliximab to patients in these groups.
It is recommended to exclude driving a car and driving potentially unsafe equipment during the period of treatment with Remicade.

Studies of the drug Remicade in pregnant women have not been conducted. Theoretically, infliximab can affect the development of immune responses in the fetus, therefore, Remicade should not be used during pregnancy.
During the period of therapy with Remicade, as well as within 6 months after the last injection of infliximab, pregnancy should not be planned (to prevent pregnancy, contraceptive methods should be used more reliably).
In newborns whose mothers received Remicade (including within 12 months before conception), vaccination with live vaccines under the age of 6 months should be carried out very carefully.
There is no data on the penetration of the active ingredient of the drug Remicade into breast milk. During lactation, the use of infliximab is not recommended, if therapy cannot be avoided, the issue of interrupting breastfeeding should be resolved.
In patients with rheumatoid arthritis, Crohn’s disease and psoriatic arthritis, with the combined use of the drug Remicade with immunomodulators, there is a decrease in the formation of antibodies to infliximab.This effect is not necessary, for example, with the use of corticosteroids, there is no change in the pharmacokinetics of infliximab.
The combined use of the drug Remicade with abatacept and anakinra is prohibited.
Remicade should not be used concurrently with live vaccine immunization.
It is forbidden to mix Remicade solution with other drugs (excluding solutions intended for the preparation of Remicade solution).
There was no development of acute toxicity with the use of high doses of Remicade (in particular, after a single administration of the drug at a dose of 20 mg / kg of body weight, the patients did not develop intoxication).
With the development of an overdose, the patient’s condition should be monitored and symptomatic therapy should be carried out according to indications.
Lyophilized powder for the preparation of parenteral solution Remicade in 20 ml vials, in a cardboard box 1 vial.
Remicade should be stored out of the reach of children in rooms where the temperature is maintained between 2 and 8 degrees Celsius. It is forbidden to freeze the powder.
The finished solution is stable for 24 hours, however, from a microbiological point of view, the finished Remicade preparation should not be stored for more than 3 hours.
The unused portion of the solution should be disposed of.
Shelf life of Remicade powder in sealed vials is 3 years.

The manual was compiled by a team of authors and editors of the Piluli website. The list of authors of the reference book of medicines is presented on the page of the site editorial office: Site editorial board.

References to used sources of information.

The description of the drug “ Remicade ” on this page is a simplified and supplemented version of the official instructions for use.Before purchasing or using the drug, you should consult with your doctor and familiarize yourself with the annotation approved by the manufacturer.
Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide on the appointment of the drug, as well as determine the doses and methods of its use.

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REMICADE instructions for use, price, analogs, indications, compatibility, reviews

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