What are the potential side effects of Humira. How does Humira impact the immune system. Who should not take Humira. What precautions should be taken when using Humira. How does Humira affect cancer risk. What infections are associated with Humira use. How should patients prepare before starting Humira treatment.

Overview of Humira (Adalimumab) and Its Uses

Humira, also known by its generic name adalimumab, is a biologic medication used to treat various autoimmune conditions. It belongs to a class of drugs called tumor necrosis factor (TNF) blockers, which work by suppressing parts of the immune system. While Humira can be highly effective for many patients, it’s crucial to understand its potential side effects and safety considerations.

Important Safety Information: Infection Risks

One of the primary concerns with Humira is its impact on the immune system’s ability to fight infections. Patients considering Humira should be aware of the following:

• Humira should not be started if you have an active infection, unless your doctor specifically approves it.
• Serious infections, including tuberculosis (TB), have occurred in people taking Humira.
• Some infections caused by viruses, fungi, or bacteria have spread throughout the body, and in rare cases, resulted in death.

Do patients need to be tested for tuberculosis before starting Humira. Yes, doctors should test for TB before initiating Humira treatment and monitor patients closely for TB signs and symptoms during treatment, even if the initial TB test was negative. In some cases, doctors may prescribe TB medication as a preventive measure if they believe a patient is at risk.

Cancer Risks Associated with Humira

The use of TNF blockers like Humira has been associated with an increased risk of certain cancers. Here’s what patients should know:

• Both children and adults taking TNF blockers may have a higher chance of developing lymphoma or other cancers.
• Unusual cancers have been reported in children, teenagers, and young adults using TNF blockers.
• A rare and often fatal cancer called hepatosplenic T-cell lymphoma has been observed in some patients using TNF blockers.
• The risk of certain skin cancers (basal cell and squamous cell carcinoma) may increase with Humira use.

How should patients monitor for skin cancer while on Humira. Patients should regularly check their skin for any new bumps or open sores that don’t heal and report these to their doctor promptly. While these skin cancers are generally not life-threatening if treated early, vigilance is key.

Rare but Serious Side Effects

In addition to infection and cancer risks, Humira may cause other serious side effects:

• Nervous system problems, including multiple sclerosis and Guillain-Barré syndrome
• Heart failure
• Liver problems, particularly in patients with pre-existing hepatitis B
• Blood disorders

Pre-Treatment Considerations: What to Tell Your Doctor

Before starting Humira, it’s crucial to have an open and thorough discussion with your healthcare provider. Be sure to disclose:

1. Any current infections or history of recurring infections
2. Diabetes diagnosis
3. History of tuberculosis or close contact with someone who has TB
4. Travel or residence in areas with increased risk of certain fungal infections
5. History of hepatitis B
6. Upcoming major surgeries
7. Any past or present cancer diagnoses
8. Nervous system conditions
9. Heart problems, especially heart failure
10. Recent or scheduled vaccinations

Why is it important to discuss travel history with your doctor before starting Humira. Certain regions, such as the Ohio and Mississippi River valleys, have a higher prevalence of fungal infections like histoplasmosis, coccidioidomycosis, or blastomycosis. Humira may increase the risk or severity of these infections, so your doctor needs this information to assess your risk and potentially provide preventive treatment.

Vaccination Considerations for Humira Patients

Vaccinations are an important aspect of overall health, but special considerations apply to Humira patients:

• Patients on Humira can generally receive vaccines, with one crucial exception: live vaccines are not recommended.
• Children should be brought up to date on all vaccinations before starting Humira treatment.
• Discuss any recent or upcoming vaccinations with your healthcare provider to ensure proper timing and safety.

Can patients on Humira receive the flu shot. Yes, Humira patients can and should receive the annual flu vaccine, as it is not a live vaccine. However, it’s always best to consult with your doctor about the timing of vaccinations in relation to your Humira treatment schedule.

Monitoring and Managing Side Effects

While on Humira, patients should remain vigilant for potential side effects and maintain regular communication with their healthcare team. Key points to remember:

• Report any signs of infection promptly, such as fever, chills, or persistent cough.
• Be aware of symptoms that could indicate more serious complications, like unexplained weight loss, night sweats, or unusual skin changes.
• Attend all scheduled check-ups and follow your doctor’s recommendations for blood tests and other monitoring procedures.
• Inform all healthcare providers, including dentists, that you are taking Humira before undergoing any medical procedures or starting new medications.

How often should patients on Humira have follow-up appointments. The frequency of follow-up appointments can vary based on individual circumstances, but typically, patients should expect to see their doctor every 3 to 6 months for routine monitoring. However, more frequent visits may be necessary if side effects occur or if adjusting the treatment plan.

Special Populations and Humira Use

Certain groups of patients require additional considerations when using Humira:

Pregnant and Breastfeeding Women

Limited data is available on the use of Humira during pregnancy and breastfeeding. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the potential risks and benefits with their healthcare provider.

Elderly Patients

Older adults may be at higher risk for certain side effects, particularly infections. Careful monitoring and potentially adjusted dosing may be necessary for this population.

Pediatric Patients

Humira is approved for use in children for certain conditions. However, the long-term effects of TNF blockers in children are not fully known, and parents should carefully weigh the benefits against potential risks.

Are there any age restrictions for Humira use in children. The approved age for Humira use varies depending on the specific condition being treated. For example, it’s approved for children as young as 2 years old for juvenile idiopathic arthritis, but age restrictions may differ for other conditions. Always consult with a pediatric specialist for the most up-to-date guidelines.

Drug Interactions and Humira

Humira can interact with various medications and substances, potentially affecting its efficacy or increasing the risk of side effects. Patients should be aware of the following:

• Avoid using Humira with other biologic medications, particularly other TNF blockers.
• Certain medications that affect the immune system, such as methotrexate or corticosteroids, may have interactions with Humira.
• Inform your doctor about all medications, supplements, and herbal products you are taking.

Can patients drink alcohol while taking Humira. While there is no direct interaction between Humira and alcohol, excessive alcohol consumption can weaken the immune system and potentially increase the risk of infections. Patients should discuss their alcohol use with their healthcare provider to determine what, if any, amount is safe for their individual situation.

Long-Term Outlook and Quality of Life on Humira

For many patients, Humira can significantly improve symptoms and quality of life. However, it’s important to maintain realistic expectations and understand that the medication may not work for everyone. Consider the following:

• It may take several weeks or months to see the full benefits of Humira treatment.
• Some patients may need to try different dosing schedules or combine Humira with other treatments for optimal results.
• Regular follow-ups and open communication with your healthcare team are essential for managing the long-term use of Humira.

How long can patients stay on Humira. There is no predetermined limit to how long a patient can use Humira. Many individuals remain on the medication for years if it continues to be effective and well-tolerated. However, the need for ongoing treatment should be regularly assessed by the prescribing physician, taking into account the patient’s response, potential side effects, and overall health status.

Lifestyle Considerations

While on Humira, patients may need to make certain lifestyle adjustments to minimize risks and optimize treatment outcomes:

• Practice good hygiene and avoid close contact with people who have active infections.
• Be cautious when traveling, especially to areas with higher infection risks.
• Maintain a healthy diet and exercise regimen to support overall immune function.
• Avoid smoking, as it can interfere with the effectiveness of Humira and increase infection risks.

Should patients on Humira avoid any specific foods. There are no specific food restrictions for patients taking Humira. However, maintaining a balanced, nutritious diet can help support the immune system. Some patients find that certain foods exacerbate their underlying condition, so it’s worth discussing any dietary concerns with a healthcare provider or registered dietitian.

Patient Support and Resources

Managing a chronic condition with a medication like Humira can be challenging. Fortunately, various support systems and resources are available:

• Patient assistance programs to help with medication costs
• Support groups for individuals with specific conditions treated by Humira
• Educational materials provided by healthcare providers and pharmaceutical companies
• Nurse hotlines for questions about administration and side effects

Where can patients find reliable information about Humira online. While it’s always best to consult with your healthcare provider for personalized advice, reputable sources for general information about Humira include the official Humira website, the FDA’s medication guide, and websites of respected medical organizations specializing in the conditions Humira treats, such as the Arthritis Foundation or the Crohn’s & Colitis Foundation.

Self-Injection Tips and Techniques

Many patients administer Humira through self-injection. To ensure safe and effective administration:

• Receive proper training from a healthcare professional before attempting self-injection.
• Follow the step-by-step instructions provided with your medication carefully.
• Rotate injection sites to prevent skin reactions and maintain tissue health.
• Properly dispose of used needles and syringes in a sharps container.

What should patients do if they miss a dose of Humira. If a dose is missed, take it as soon as you remember. However, if it’s almost time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Do not double up on doses to make up for a missed one. If unsure, contact your healthcare provider for guidance.

HUMIRA® (adalimumab) | A Biologic Treatment Option

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.  Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of

unusual

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections.

IMPORTANT SAFETY INFORMATION 

ABOUT HUMIRA^® (adalimumab)¹

What is the most important information I should know about HUMIRA?

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

• Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
• Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

• Have an infection, are being treated for infection, or have symptoms of an infection
• Get a lot of infections or infections that keep coming back
• Have diabetes
• Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
• Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas
• Have or have had hepatitis B
• Are scheduled for major surgery
• Have or have had cancer
• Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
• Have or had heart failure
• Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA
• Are allergic to rubber, latex, or any HUMIRA ingredients
• Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
• Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA^® (abatacept), KINERET^® (anakinra), REMICADE^® (infliximab), ENBREL^® (etanercept), CIMZIA^® (certolizumab pegol), or SIMPONI^® (golimumab). Tell your doctor if you have ever used RITUXAN^® (rituximab), IMURAN^® (azathioprine), or PURINETHOL^® (mercaptopurine, 6-MP).

What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

• Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
• Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
• Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
• Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
• Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
• Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

• Fever, sweats, or chills
• Muscle aches
• Cough
• Shortness of breath
• Blood in phlegm
• Weight loss
• Warm, red, or painful skin or sores on your body
• Diarrhea or stomach pain
• Burning when you urinate
• Urinating more often than normal
• Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Uses

HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone or with methotrexate.
  • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Ankylosing spondylitis (AS) in adults.
  • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
• To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
• To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

US-HUM-210186

Humira side effects: Common, mild, and serious

Humira (adalimumab) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat several different conditions, including:

• Crohn’s disease in adults, and in children ages 6 years and older
• ulcerative colitis in adults, and in children ages 5 years and older
• plaque psoriasis in adults
• psoriatic arthritis in adults
• rheumatoid arthritis in adults
• ankylosing spondylitis in adults
• juvenile idiopathic arthritis in children ages 2 years and older
• hidradenitis suppurativa in adults, and in children ages 12 years and older
• certain types of uveitis in adults, and in children ages 2 years and older

Here are some fast facts on Humira:

• Active ingredient: adalimumab, which is a biologic
• Drug class: tumor necrosis factor blocker
• Drug forms: single-dose pen, single-dose prefilled syringe, and single-dose vial of liquid solution; all are given by subcutaneous injection

Like other drugs, Humira can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Humira, including details about its uses, see this article.

Humira can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Humira in clinical trials:

• headache
• injection site reactions*
• rash*
• upper respiratory infections, such as the common cold

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Humira use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Humira’s medication guide.

Mild side effects that have been reported with Humira include:

• headache
• injection site reactions*
• rash*
• upper respiratory infections, such as the common cold

* For more information about this side effect, see “Side effect specifics” below.

These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Humira and want to tell the FDA about it, visit MedWatch.

Humira may cause serious side effects, although they aren’t common. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Humira’s medication guide.

If you develop serious side effects while taking Humira, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported, and their symptoms, can include:

• Nervous system problems, such as multiple sclerosis and Guillain-Barré syndrome. Symptoms can include:
  • dizziness
  • tingling or numbness
  • weakness that affects your arms or legs
  • vision problems
• Blood cell problems, such as aplastic anemia. Symptoms can include:
  • bruising or bleeding more easily than usual
  • fever that doesn’t go away
  • pallor (skin that looks paler than usual)
• Heart failure. Symptoms can include:
  • swelling in your ankles or feet
  • sudden weight gain
  • shortness of breath
• New or worsening psoriasis. Symptoms can include:
  • red, scaly patches on your skin
  • raised bumps on your skin
• Lupus-like syndrome, also known as drug-induced lupus. Symptoms can include:
  • chest discomfort or pain that doesn’t go away
  • joint pain
  • a rash on your arms or cheeks that gets worse if exposed to sunlight
  • shortness of breath
• Liver problems. *
• Reactivation of hepatitis B virus.*
• Risk of serious infections.*†
• Risk of cancer.*†
• Allergic reaction.*

* For more information about this side effect, see “Side effect specifics” below.
† Humira has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.

Side effects after first dose of Humira

It’s possible to have side effects after your first dose of Humira, such as injection site reactions. These reactions may include itching, pain, or swelling in the area of your Humira injection. It’s also possible to experience other side effects, including serious side effects, after your first dose.

Depending on the condition you’re taking Humira to treat, you may take the drug every week or every other week. It’s possible to experience side effects after these other doses, as well.

If you have questions about what to expect after your first dose of Humira, talk with your doctor or pharmacist.

It’s possible for Humira treatment to cause long-term side effects.

For example, the drug has caused growth of new cancers. It has also caused existing tumors (masses of cancerous tissue) to grow. In fact, Humira has a boxed warning about risk of cancer. For more information, see the “Side effect specifics” section below.

If you’re concerned about long-term side effects from taking Humira, talk with your doctor or pharmacist.

Humira may cause several side effects. Here are some frequently asked questions and answers about the drug’s side effects.

When comparing Humira’s benefits and risks, is it worth it to try the drug?

You and your doctor will decide whether it’s worth it for you to try Humira. Your doctor will only prescribe Humira to treat your condition if the possible benefits of the medication outweigh the risks of side effects.

Talk with your doctor about benefits and risks of potential treatments for your condition.

Can using Humira cause weight gain or weight loss?

Neither weight gain nor weight loss were reported as side effects in people taking Humira in clinical trials.

But unintended weight loss may be a symptom of other side effects of Humira, such as an infection. And sudden weight gain may be a symptom of heart failure, which is a rare but serious side effect of taking Humira.

If you’re concerned about your weight while taking Humira, talk with your doctor. They can discuss ways to help maintain a weight that’s healthy for you. If you notice unintended, sudden changes in your weight, call your doctor. This may be a symptom of more serious side effects of Humira.

Is anxiety a side effect of Humira?

No, anxiety isn’t a side effect of Humira. This wasn’t reported as a side effect in clinical trials of the drug. But Humira is used to treat some chronic (long-term) conditions, and having a chronic condition has been linked to anxiety.

If you have questions about anxiety or side effects of Humira, talk with your doctor or pharmacist.

Does Humira cause depression?

Depression isn’t a known side effect of Humira. It wasn’t reported as a side effect in clinical trials of Humira. Depression could be related to having a chronic condition, such as those that Humira is used to treat.

If you have questions about side effects of Humira, or about depression, talk with your doctor or pharmacist.

Is hair loss one of Humira’s side effects?

It’s not likely. Hair loss wasn’t a side effect seen duringclinical trials of Humira.

There have been reports of hair loss in people taking Humira since the drug was approved. But it’s unclear how often this has occurred or whether Humira was the cause.

If you have questions or concerns about hair loss while using Humira, talk with your doctor. They can suggest ways to treat this side effect. They may have you stop taking Humira and try another medication for your condition.

Learn more about some of the side effects that Humira may cause.

Skin-related side effects

It’s possible to have skin-related side effects from taking Humira. These may include a rash or injection site reactions. Both of these side effects were more common side effects in clinical trials, and were mild in most cases. Rarely, a rash can be a sign of rare but more serious side effects of Humira, such as an allergic reaction.

Injection site reactions happen at or near the site where your Humira dose was injected. Symptoms can include itching, pain, or swelling.

Humira can also cause new or worsening psoriasis.* This is a skin condition that causes symptoms such as red scaly patches of skin, and raised bumps that contain pus. This side effect was not seen in clinical trials, but has been reported since the drug was approved.

* Humira is approved to treat plaque psoriasis in adults.

What you can do

If you experience a rash while taking Humira, call your doctor. They can help determine if it’s a sign of a more serious side effect and how to treat it. They may also suggest ways to help treat this side effect. If the rash is mild, it may also go away on its own, as you continue to take Humira.

To help avoid injection site reactions, try to rotate where you inject your Humira doses. Don’t give injections in places where your skin is hard, red or discolored, or bruised.

Injection site reactions usually go away on their own after a few days. But, if you experience a reaction that doesn’t go away or bothers you, talk with your doctor. They can suggest ways to relieve your symptoms. They may also suggest trying a drug other than Humira for your condition.

You should also talk with your doctor if you develop new or worse psoriasis symptoms. Your doctor may have you stop taking Humira if this happens.

Liver problems

In very rare cases, Humira may cause liver problems, including liver damage and sudden liver failure. But liver problems have rarely been reported in people using the drug since it was approved.

Symptoms of liver problems can include:

• abdominal (belly) pain, especially on your right side
• jaundice (yellowing of your skin or the whites of your eyes)
• loss of appetite
• vomiting
• fatigue (lack of energy)

What you can do

Call your doctor right away if you notice any symptoms of liver problems. Sometimes liver problems may require treatment at a hospital. If you do develop liver problems, your doctor may have you stop taking Humira and try a different medication for your condition.

Hepatitis B reactivation

If you’ve previously had an infection called hepatitis B, Humira can make the virus that causes it active again. This can cause symptoms such as:

• muscle aches
• jaundice (yellowing of your skin or the whites of your eyes)
• reduced appetite or no appetite
• fatigue (lack of energy)
• upset stomach
• dark-colored urine or clay-colored stool

In rare cases, hepatitis B reactivation in people taking drugs such as Humira can be fatal.

Before you begin taking Humira, you’ll take a hepatitis B virus (HBV) test. Your doctor may continue to test you for HBV while you take Humira, and for several months after your last dose if you stop taking the drug.

What you can do

If you develop symptoms of hepatitis B reactivation, talk with your doctor right away. They can determine the best way to treat your symptoms, which may involve having you stop taking Humira.

Serious infections

Humira has a boxed warning for risk of serious infections. A boxed warning is a serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Taking Humira can increase your risk for serious bacterial, fungal, and viral infections, including tuberculosis (TB). This is because the drug affects your immune system, and can lower your body’s ability to fight infections. These infections may require treatment in the hospital and, rarely, can be fatal.

What you can do

Before you start taking Humira, your doctor will test you for TB. If you test positive for TB, it will need treatment before you can safely take Humira.

While taking Humira, your doctor will closely monitor you for symptoms of any infections. They’ll likely have you stop taking Humira if you develop a serious infection.

Cancer

Humira has a boxed warning for risk of cancer. A boxed warning is a serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.

Taking Humira may increase your risk for certain types of skin cancer, although this is rare.

Cancers have occurred in people taking Humira, including adolescents and children. These cancers include lymphomas (cancers of the white blood cells).

In particular, a lymphoma called hepatosplenic T-cell lymphoma has been rarely reported, mostly in young adult and adolescent males* with either Crohn’s disease or ulcerative colitis.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

What you can do

While taking Humira, your doctor will monitor you for new cancers, including lymphoma.

If your skin develops a bump or an open sore that doesn’t heal, call your doctor. This may be a sign of skin cancer caused by Humira. You should also call your doctor if you develop lymphoma symptoms or possible symptoms of other cancers, such as:

• unexplained weight loss
• fatigue (lack of energy)
• night sweats
• itching
• fever
• chills

Allergic reaction

As with most drugs, Humira can cause an allergic reaction in some people. Symptoms can be mild or serious and can include:

• rash
• itching
• flushing
• swelling under your skin, typically in your lips, eyelids, feet, or hands
• swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Humira. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Below are details on warnings and precautions to keep in mind before you take Humira.

Boxed warnings

This drug has boxed warnings about risk of serious infections and cancer. These are serious warnings from the Food and Drug Administration (FDA). For more information, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Humira. This drug may not be right for you if you have certain medical conditions or other factors that affect your health. Conditions and factors to consider include:

Active infection. You shouldn’t start taking Humira if you have any kind of infection, unless your doctor approves. Your doctor may want to treat your infection before you take Humira. Make sure to tell your doctor about all conditions you have, including any infections, before starting Humira treatment.

Heart failure. Humira belongs to a group of drugs called tumor necrosis factor (TNF) blockers. This type of drug has been reported to cause heart failure or make existing heart failure worse. So if you have heart failure, your doctor will want to closely monitor you while you’re taking Humira.

Liver damage. If you have a history of liver damage or liver disease, make sure to discuss this with your doctor before starting Humira. It’s possible for TNF blockers such as Humira to cause severe liver damage. For this reason, your doctor may monitor your liver function while you’re taking Humira.

Nervous system problems, such as multiple sclerosis (MS). Humira can make symptoms of nervous system problems and demyelinating diseases worse. Examples of these types of conditions include MS and seizures. If you have a nervous system problem, be sure to talk with your doctor about whether Humira is the best choice for you.

Hepatitis B. If you’ve had hepatitis B in the past, Humira can cause the virus to become active if you stop taking the drug. Be sure your doctor is aware if you’ve ever had hepatitis B. Before you begin taking Humira, you’ll be tested for hepatitis B. You may continue to have these tests while you take Humira, and for several months after your last dose if you stop taking the drug.

Cancer. Humira can cause cancer, or can cause existing cancerous tumors to get worse. In fact, Humira has a boxed warning for this side effect (see “Side effect specifics” above for details). If you have cancer, talk with your doctor before you begin taking Humira.

Recent vaccination. If you’ve recently received a live vaccine, talk with your doctor about when it’s safe for you to begin taking Humira. (Live vaccines contain a small amount of a weakened live virus or bacteria. ) You shouldn’t receive live vaccines while taking Humira. Your doctor may want to make sure you’re up to date on your vaccinations before having you take Humira.

Latex allergy or allergic reaction. You shouldn’t take Humira if you’ve ever had an allergic reaction to any of its ingredients, including latex. Some Humira products come with a needle cover that could contain natural rubber latex. If you have a latex allergy, talk with your doctor about other treatments or other forms of Humira that may be better choices for you.

Alcohol use with Humira

There aren’t known interactions between alcohol and taking Humira. But drinking alcohol may worsen some of the conditions Humira is used to treat. These include plaque psoriasis and Crohn’s disease.

If you have questions about drinking alcohol while taking Humira, talk with your doctor.

Pregnancy and breastfeeding while taking Humira

You and your doctor should decide whether Humira is the right choice for you to take while you’re pregnant or breastfeeding.

It isn’t known for sure whether Humira is safe to take while pregnant or breastfeeding. In people who have taken the drug while breastfeeding, no side effects have been reported.

If you have questions about taking Humira while pregnant or breastfeeding, talk with your doctor.

Side effects from Humira aren’t common. And, they’re usually mild when they do occur. Most mild side effects of the drug go away with time and don’t require medical attention. But in rare cases, Humira can cause serious side effects. You should talk with your doctor if you experience symptoms of any side effects during treatment.

If you’d like to learn more about Humira, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

• More information about Humira. For details about other aspects of Humira, refer to this article.
• Dosage details. For information about Humira’s dosage, see this article.
• Drug comparison. To learn how Humira compares with other drugs, read the comparison articles on these medications: Cosentyx, Cimzia, Enbrel, and Stelara.
• Details on your condition. For details on your condition, our inflammatory bowel disease hub and rheumatoid arthritis hub may be helpful. You can also see our lists of:
  • psoriasis articles
  • ulcerative colitis articles
  • rheumatology articles
  • Crohn’s articles
  • psoriatic arthritis articles
  • dermatology articles
  • eye health articles

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 another 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.

Memorial Sloan Kettering Cancer Center

Adult Medication

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Provided by Lexicomp ^® , this document contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Amjevita; Humira; Humira Pediatric Crohns Start; Humira Pen; Humira Pen-CD/UC/HS Starter; Humira Pen-Pediatric UC Start; Humira Pen-Ps/UV/Adol HS Start; Humira Pen-Psor/Uveit Starter

Trade names: Canada

Abrilada; Amgevita; Amgevita SureClick; Hadlima; Hadlima Push Touch; Hulio; Humira; Hyrimoz; Idacio; Simlandi; Yuflyma

Warning

• Very bad and sometimes deadly infections have occurred in patients taking this drug. Most patients with these infections were taking other drugs to lower the activity of the immune system, such as methotrexate or steroid drugs. If you have any infection, are currently taking or have recently taken antibiotics, or if you have had many infections in the past, talk to your doctor.
• Tuberculosis has developed in patients who started taking this drug. These patients have been in contact with TB patients in the past but have not developed the infection. Before you start taking this medicine, you will need to have a test to see if you have had TB in the past.
• Cases of lymphoma and other malignancies have been reported in children and adolescents taking this or a similar drug. These neoplasms have also been found in adults. In some cases, this has led to death. If you have any questions, please consult your doctor.
• A rare cancer called T-cell lymphoma of the liver and spleen (HSTCL) has been seen with this drug and other drugs of this kind. These cases ended in death. Nearly all cases have been reported in people who have taken drugs of this kind such as this along with certain other drugs (azathioprine or 6-mercaptopurine). In most cases, they occurred during treatment for Crohn’s disease or ulcerative colitis. Also, in most cases, they occurred in teenage boys or young men. Consult your doctor.

What is this drug used for?

• Used to treat certain types of arthritis.
• Used to treat Crohn’s disease.
• This drug is used to treat ankylosing spondylitis.
• It is used to treat plaque psoriasis.
• It is used to treat ulcerative colitis.
• It is used to treat a skin disorder called hidradenitis suppurativa.
• Used to treat uveitis.
• This drug may also be used for other indications. Consult your doctor.

What should I tell my doctor BEFORE taking this drug?

• If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.
• If you are taking any of the following drugs: abatacept or anakinra.
• If you are taking another drug like this one. If in doubt, consult your doctor or pharmacist.

This list of drugs and conditions that may interact with this drug is not exhaustive.

Tell your doctor and pharmacist about all medicines you take (prescription and over-the-counter, natural products and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

• Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• You may be at increased risk of developing an infection. Wash your hands frequently. Try not to contact with carriers of the infection, incl. with people who have a cold or the flu.
• If you have had hepatitis B in the past or are a carrier of the virus, consult your doctor. Drugs of this type can activate the virus. This can lead to very serious, sometimes deadly liver problems.
• Hepatitis B tests should be done as directed by your doctor. Consult your doctor.
• There is an increased chance of bleeding. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Before starting treatment with this drug, make sure you know all the vaccines you have received so far.
• Consult your doctor before any vaccination. Taking some vaccines with this drug may increase your chance of getting an infection or make the vaccine less effective.
• While using this drug, weakened bacteria such as BCG should not be administered to treat bladder cancer. Consult with your doctor.
• Perform blood tests as directed by your doctor. Consult with your doctor.
• The use of this drug was accompanied by an increase in cholesterol levels. If you have any questions, please consult your doctor.
• If you are allergic to latex, please consult your doctor. Some products contain latex.
• If you have sunburn or other skin problems, check with your doctor.
• Get a skin examination. Tell your doctor if you have any skin changes, such as a new wart, skin ulcer, or reddish swelling that bleeds or won’t heal, or a change in the color or size of a mole.
• The intake of such drugs was occasionally accompanied by the appearance of disorders of the nervous system in patients. Sometimes these disturbances did not disappear. Call your doctor right away if you have a burning, numbness or tingling sensation that is not normal, blurred vision, dizziness, cramps or weakness in your arms or legs.
• There have been cases of dangerous disorders in the level of blood cells, such as aplastic anemia and a variant of low white blood cells. Tell your doctor right away if you feel very tired or weak, have a fever, chills, shortness of breath, unexplained bruising and bleeding, or purple “spots” on your skin.
• If you are 65 years of age or older, use this drug with caution. You may experience more side effects.
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.
• Tell your child’s doctor if you have taken this drug during pregnancy. You should discuss the safety and timing of certain vaccines with your doctor.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Contact your doctor or seek medical attention right away if you have any of the following signs or symptoms that may be associated with serious side effects:

• Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• Signs of infection, such as fever, chills, very bad pain in the throat, ear, or sinuses, cough, more sputum or change in color, pain when urinating, mouth sores, or a sore that doesn’t heal.
• Signs of a urinary tract infection, including blood in the urine, burning or painful urination, frequent or immediate urge to urinate, fever, pain in the lower abdomen or pelvis.
• Symptoms of lupus, such as a rash on the cheeks or other parts of the body, quick sunburn, muscle or joint pain, chest pain or shortness of breath, and swelling in the arms and legs.
• Signs of high blood pressure, such as a very severe headache, or dizziness, or loss of consciousness, or blurred vision.
• Swelling or growth of the skin.
• Pale skin.
• Red, rough patches or vesicles filled with pus.
• Call your doctor right away if you experience symptoms such as swollen lymph nodes, night sweats, shortness of breath, and unexplained weight loss.
• The use of drugs like this has been associated with liver problems. In some cases, this has led to death. Call your doctor right away if you develop signs of liver problems such as dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, yellowing of the skin or eyes.
• There have been cases of heart failure and worsening of pre-existing heart failure with this drug. Consult your physician if you have heart disease. If you experience shortness of breath, a sudden increase in body weight, irregular heartbeat, swelling of the arms and legs, or if these symptoms worsen, consult a doctor immediately.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Contact your doctor or seek medical attention if these or any other side effects bother you or do not go away:

• Headache.
• Signs of a cold.
• Pain in the intestines.
• Nausea.
• Back pain.
• Pain, redness, inflammation, or reaction at the injection site.

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

All forms:

• It is given as an injection into the subcutaneous fat of the upper thigh or abdomen.

Automatic medical syringes, pre-filled pens and pre-filled syringes:

• If you inject yourself, your doctor or nurse will teach you how to inject.
• Wash your hands before and after use.
• Some drugs should not be shaken. However, some preparations must be shaken gently to see the liquid in the viewing window. You must know exactly whether shaking this drug is allowed.
• Do not use if solution is cloudy, leaking, or contains particles.
• Depending on the brand name of this drug, it may be clear or slightly colored. Before using, find out what your brand name product should look like. Do not use the solution if it has changed color. If in doubt, consult your pharmacist.
• Do not inject into skin within 2 inches (5 cm) of the navel.
• Do not apply to areas with soreness, bruising, redness, or hardening of the skin.
• Change the injection site with each injection.
• To make it easier to transfer the injection, remove the drug from the refrigerator and keep at room temperature for 30 minutes before use. Do not remove the lid or cap. Do not heat the drug.
• Throw away after use. Do not use the device more than once.
• Dispose of needles in the used sharps/needles container. Needles and other items cannot be reused. When the container is full, dispose of it according to local regulations. If you have any questions, ask your doctor or pharmacist.

What if I miss a dose of a drug?

Automatic medical syringes, pre-filled pens and pre-filled syringes:

• Take the missed dose as soon as you can and then return to your regular schedule.
• If you miss a dose and are not sure what to do, contact your doctor.

Vials:

• See your doctor for further instructions.

How do I store and/or discard this drug?

Automatic medical syringes, pre-filled pens and pre-filled syringes:

• Store in refrigerator. Don’t freeze.
• Do not use the drug if it has been frozen.
• Store in original packaging to protect from light.
• If necessary, storage at room temperature for some time is allowed. Be sure to find out how long this drug can be stored at room temperature. Write down the date you took the medicine out of the refrigerator. If the drug was stored at room temperature and was not used before the expiration of the named time, it should be discarded.
• Keep out of the heat.

Vials:

• If you need to store this drug at home, check with your doctor, nurse, or pharmacist for storage conditions.

All forms:

• Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

• If your health does not improve or even worsens, see your doctor.
• Do not give your medicine to anyone and do not take other people’s medicines.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• A separate instruction for patients is attached to the drug. Please read this information carefully. Reread it each time you refill your supply. If you have any questions about this drug, ask your doctor, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient. It should not be considered medical advice or a substitute for medical advice, diagnosis or treatment provided by a physician based on a medical examination and assessment of the patient’s specific and unique circumstances. Patients should consult with their physician for full information about their health, medical issues, and treatment options, including any risks or benefits regarding the use of medications. This information is not a guarantee that a treatment or drug is safe, effective, or approved for a particular patient. UpToDate, Inc. and its subsidiaries disclaim any warranties or liabilities related to this information or its use. The use of this information is subject to the Terms of Use found at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last revision date

2023-03-17

Copyright

© UpToDate, Inc. and its affiliates and/or licensors, 2023. All rights reserved.

Date last updated

Monday, December 12, 2022

Adalimumab: Pediatric Medication | Memorial Sloan Kettering Cancer Center

Pediatric Medicine

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This document provided by Lexicomp ^® contains all the information you need to know about the drug, including indications, directions for use, side effects, and when you should contact your healthcare provider.

Trade names: USA

Amjevita; Humira; Humira Pediatric Crohns Start; Humira Pen; Humira Pen-CD/UC/HS Starter; Humira Pen-Pediatric UC Start; Humira Pen-Ps/UV/Adol HS Start; Humira Pen-Psor/Uveit Starter

Brand names: Canada

Abrilada; Amgevita; Amgevita SureClick; Hadlima; Hadlima Push Touch; Hulio; Humira; Hyrimoz; Idacio; Simlandi; Yuflyma

Warning

• Very bad and sometimes deadly infections have occurred in patients taking this drug. Most patients with these infections were taking other drugs to lower the activity of the immune system, such as methotrexate or steroid drugs. If your child has any infection, current or recent antibiotic use, or multiple infections, talk to your child’s doctor.
• Tuberculosis (TB) has been observed in patients who started taking this drug. These patients have had contact with TB in the past but have never developed an infection. Before starting this drug, your doctor will give your child a test to see if they have had a history of exposure to TB.
• Cases of lymphoma and other malignancies have been reported in children and adolescents taking this or a similar drug. These neoplasms have also been found in adults. In some cases, this has led to death. If you have any questions, please consult your doctor.
• A rare cancer called T-cell lymphoma of the liver and spleen (HSTCL) has been seen with this drug and other drugs of this kind. These cases ended in death. Nearly all cases have been reported in people who have taken drugs of this kind such as this along with certain other drugs (azathioprine or 6-mercaptopurine). In most cases, they occurred during treatment for Crohn’s disease or ulcerative colitis. Also, in most cases, they occurred in teenage boys or young men. Consult your doctor.

What is this drug used for?

• Used to treat certain types of arthritis.
• Used to treat Crohn’s disease.
• It is used to treat ulcerative colitis.
• It is used to treat a skin disorder called hidradenitis suppurativa.
• Used to treat uveitis.
• This drug can be given to children for other indications. Consult your doctor.

What do I need to tell the doctor BEFORE my child takes this drug?

• If your child has an allergy to this drug, any of its ingredients, other drugs, foods, or substances. Tell the doctor about the allergy and how it manifested itself in the child.
• If your child is taking any of these drugs: abatacept or anakinra.
• If your child is taking a similar drug. If in doubt, ask your child’s doctor or pharmacist for advice.

This list of drugs and conditions that may interact with this drug is not exhaustive.

Talk to your doctor or pharmacist about all medicines your child is taking (prescription and over-the-counter, natural, and vitamins) and any health problems. You need to make sure that this drug is safe to use for your child’s illnesses and in combination with other drugs he or she is already taking. Do not start, stop taking, or change the dosage of any drug your child is taking without the doctor’s approval.

What do I need to know or do while my child is taking this drug?

• Tell all health care providers who care for your child that your child is taking this drug. These are your child’s doctors, nurses, pharmacists and dentists.
• Before starting treatment with this drug, make sure you know all the vaccines your child has received up to now.
• Talk to your doctor before your child gets any vaccines. Taking some vaccines with this drug may make you more likely to get a serious infection or make the vaccine less effective.
• Your child may be at increased risk of developing infections. Make sure your child is washing their hands often. Avoid crowded places and contact with people with infections, colds or the flu.
• If your child has had hepatitis B or is a carrier of the virus, talk to your child’s doctor. Drugs of this type can activate the virus. This can lead to very serious, sometimes deadly liver problems.
• Hepatitis B tests should be done as directed by your doctor. Consult your doctor.
• Your child may become more prone to bleeding. Make sure your child is careful to avoid injury. Make sure your child uses a soft toothbrush.
• Make sure your child is not being treated for weakened bacteria while taking this drug, such as using BCG for bladder cancer. Consult your doctor.
• Perform blood tests as directed by your doctor. Consult with your doctor.
• The use of this drug was accompanied by an increase in cholesterol levels. If you have any questions, please consult your doctor.
• If your child is allergic to latex, talk to your doctor. Some products contain latex.
• If your child has sunburn or other skin problems, talk to your doctor.
• Examine the child’s skin. Tell your doctor if your child has any skin changes, such as a new wart, a skin ulcer, or a reddish swelling that bleeds or won’t heal, or a change in the color or size of a mole.

If your daughter is pregnant or breastfeeding:

• Consult physician if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her baby will need to be discussed.
• If your daughter has used this drug during pregnancy, tell your daughter’s doctor. You will need to discuss the safety and timing of certain vaccines with your doctor.

What side effects should I report to my child’s doctor right away?

WARNING/CAUTION: Although rare, some people may have very serious and sometimes deadly side effects of this drug. Call your child’s doctor right away or get medical help if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

• Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• Signs of infection, such as fever, chills, very bad pain in the throat, ear, or sinuses, cough, more sputum or change in color, pain when urinating, mouth sores, or a sore that doesn’t heal.
• Signs of a urinary tract infection, including blood in the urine, burning or painful urination, frequent or immediate urge to urinate, fever, pain in the lower abdomen or pelvis.
• Symptoms of lupus, such as a rash on the cheeks or other parts of the body, quick sunburn, muscle or joint pain, chest pain or shortness of breath, and swelling in the arms and legs.
• Signs of high blood pressure, such as a very severe headache, or dizziness, or loss of consciousness, or blurred vision.
• Swelling or growth of the skin.
• Pale skin.
• Red, rough patches or vesicles filled with pus.
• Call your doctor right away if your child has symptoms such as swollen lymph nodes, night sweats, shortness of breath, and unexplained weight loss.
• The intake of such drugs was occasionally accompanied by the appearance of disorders of the nervous system in patients. Sometimes these disturbances did not disappear. Call your doctor right away if your child has a burning, numbness or tingling sensation that is not normal, blurred vision, dizziness, cramps or weakness in the arms or legs.
• The use of drugs like this has been associated with liver problems. In some cases, this has led to death. Call your doctor right away if your child shows signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea or abdominal pain, light-colored stools, vomiting, yellowing of the skin or eyes.
• There have been cases of heart failure and worsening of pre-existing heart failure with this drug. See a doctor if your child has heart disease. Call your doctor right away if your child develops shortness of breath, weight gain, irregular heartbeat, swelling of the arms and legs, or if these symptoms worsen.
• There have been cases of dangerous disorders in the level of blood cells, such as aplastic anemia and a variant of low white blood cells. Tell your doctor right away if your child feels very tired or weak, has a fever, chills, shortness of breath, unexplained bruising and bleeding, or purple “spots” on the skin.

What are some other side effects of this drug?

Any drug can cause side effects. However, for many people, side effects are either minor or non-existent. Contact your child’s doctor or seek medical attention if any of these or other side effects bother your child or if they persist:

• Headache.
• Signs of a cold.
• Pain in the intestines.
• Nausea.
• Back pain.
• Pain, redness, inflammation, or reaction at the injection site.

This list of possible side effects is not exhaustive. If you have any questions about side effects, ask your child’s doctor. Talk to your child’s doctor about side effects.

You can report the development of side effects to the national health authority.

What is the best way to give this drug?

Give this drug to your child as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

All forms:

• It is given as an injection into the subcutaneous fat of the upper thigh or abdomen.

Automatic medical syringes, pre-filled pens and pre-filled syringes:

• If you will give your child injections yourself, your child’s doctor or nurse will teach you how to give injections.
• Wash your hands before and after use.
• Some drugs should not be shaken. However, some preparations must be shaken gently to see the liquid in the viewing window. You must know exactly whether shaking this drug is allowed.
• Do not use if solution is cloudy, leaking, or contains particles.
• Depending on the brand name of this drug, it may be clear or slightly colored. Before using, find out what your brand name product should look like. Do not use the solution if it has changed color. If in doubt, consult your pharmacist.
• Do not inject into skin within 2 inches (5 cm) of the navel.
• Do not apply to areas with soreness, bruising, redness, or hardening of the skin.
• Change the injection site with each injection.
• To make it easier to transfer the injection, remove the drug from the refrigerator and keep at room temperature for 30 minutes before use. Do not remove the lid or cap. Do not heat the drug.
• Throw away after use. Do not use the device more than once.
• Dispose of needles in the used sharps/needles container. Needles and other items cannot be reused. When the container is full, dispose of it according to local regulations. If you have any questions, ask your doctor or pharmacist.

What if my child misses a dose of medication?

Automatic medical syringes, pre-filled pens and pre-filled syringes:

• Give the child the missed dose as soon as you remember and give the next dose at the usual time.
• If you are not sure what to do if your child misses a dose, contact your doctor.

Vials:

• Contact your child’s doctor to find out the next steps.

How do I store and/or discard this drug?

Automatic medical syringes, pre-filled pens and pre-filled syringes:

• Store in refrigerator. Don’t freeze.
• Do not use the drug if it has been frozen.
• Store in original packaging to protect from light.
• If necessary, storage at room temperature for some time is allowed. Be sure to find out how long this drug can be stored at room temperature. Write down the date you took the medicine out of the refrigerator. If the drug was stored at room temperature and was not used before the expiration of the named time, it should be discarded.
• Keep out of the heat.

Vials:

• If you need to store this drug at home, check with your child’s doctor, nurse, or pharmacist about how to store it.

All forms:

• Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

• If your child’s symptoms or health problems do not improve, or worsen, contact your child’s doctor.
• Do not share your child’s medicine with others and do not give anyone else’s medicine to your child.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options.