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Side effects from humira injections: Important Safety Information | HUMIRA (adalimumab)

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Important Safety Information | HUMIRA (adalimumab)

Discuss Important Safety Information for HUMIRA with your doctor.

Before you and your doctor make a decision about treatment, you should discuss the Important Safety Information for HUMIRA. Talk about any concerns you may have. Working together, you and your doctor can find a treatment that is right for you.

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 tumor necrosis factor (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. 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.

 

Learn about the most common side effects of HUMIRA.

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.

It is possible to experience adverse events or side effects from HUMIRA. If you do experience any side effects, call your doctor right away. These are not all of the possible side effects associated with HUMIRA. Click here to see additional Important Safety Information.

Humira side effects and how to avoid them

Humira side effects | How long do side effects last? | Warnings | Interactions | How to avoid side effects

Humira (adalimumab)—an injection of a naturally occurring human antibody—induces remission and controls the symptoms of active autoimmune diseases. A healthcare provider may prescribe Humira for rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, uveitis, and hidradenitis suppurativa. In all these conditions, flare-ups occur when the immune system mistakenly attacks healthy tissues. 

Humira suppresses the body’s immune response by blocking a chemical produced by the body—tumor necrosis factor or TNF—that causes swelling. As with all medications, the decision to take Humira must balance the benefits and risks of the medication, so it is important to discuss with your doctor the side effects, drug interactions, and warnings associated with the drug. 

RELATED: Learn more about Humira | Get Humira discounts

Common side effects of Humira

Humira suppresses the immune system, so infections and malignancies are common as well as potentially serious side effects. Also, as a subcutaneous injection, Humira produces injection site reactions in about 1 in 5 patients. The most common side effects of Humira are:

  • Injection site reactions (redness, swelling, pain, itching, and skin rash)
  • Upper respiratory infections
  • Sinus congestion
  • Headache
  • Development of autoimmune antibodies
  • Rash
  • Nausea
  • Abdominal pain
  • Abnormal liver function
  • Urinary tract infection
  • Flu or cold symptoms
  • Back pain
  • Increased levels of fat in the bloodstream
  • Elevated serum cholesterol
  • High blood pressure

Does Humira cause hair loss or weight gain?

In very rare cases, Humira may cause some hair loss.  

Unexplained weight loss or weight gain, though, is not directly caused by Humira. However, its active ingredient increases the risk of lymphoma, leukemia, and other cancers, many of which are characterized by loss of appetite and involuntary weight loss. Talk to a doctor immediately if you notice weight loss, decreased appetite, or getting full on a small amount of food while taking Humira.

Serious side effects of Humira

Because Humira suppresses the immune system, patients are at an increased risk of severe and even life-threatening infections and cancers. As with all antibody injections, allergic reactions are also a risk. The most severe side effects of Humira are

  • Serious or life-threatening infections
  • Cancer (lymphoma, leukemia, non-melanoma skin cancer, and other malignancies)
  • Severe or life-threatening allergic reactions
  • Tuberculosis or hepatitis B virus reactivation
  • Exacerbation or onset of nervous system disorders such as multiple sclerosis or optic neuritis
  • Heart problems (atrial fibrillation, tachycardia, cardiac arrhythmia, chest pain, heart attack)
  • Worsening of congestive heart failure
  • Lupus-like syndrome
  • Lowered blood cell counts or anemia
  • Liver damage or failure
  • Gallstones
  • Cataracts
  • Arthritis
  • Muscle weakness
  • Confusion

You should stop taking Humira and seek immediate medical attention if you experience any of the following adverse reactions when taking Humira:

  • Fever, fatigue, loss of appetite, abdominal pain, or other signs of a hepatitis B infection.
  • Swollen glands, tiredness, fever, chills, night sweats, loss of appetite, involuntary weight loss, unexplained skin bumps, easy bruising or bleeding, or other common signs of cancer.
  • Hives, facial swelling, blistering, purple skin, trouble breathing, drop in blood pressure, dizziness, fainting, or other signs of a severe allergic reaction or anaphylaxis.
  • Fatigue, fever, joint pain, facial rash, sunlight-induced skin lesions, shortness of breath, and other signs of lupus-like syndrome.
  • Racing heartbeat, palpitations, chest pain, or other signs of heart irregularities.

Humira injections may be discontinued if any of these conditions are experienced.

You should immediately talk to your doctor about the possibility of discontinuing Humira if you experience:

  • Fever, cough, swelling, chills, swollen glands, loss of appetite, abdominal pain, or other signs of infection.
  • Weakness, fatigue, pale skin, fast heartbeat, easy bruising or bleeding, or other signs of blood problems.
  • Yellow skin, yellowing eyes, right-side upper abdominal pain, abdominal swelling, disorientation, and other signs of acute liver problems.
  • Muscle weakness, vision changes, muscle stiffness, muscle spasms, tingling, numbness, or other signs of nervous system disorders.

Humira is administered only once every two weeks, so doctors and patients have time to reconsider Humira in the face of adverse effects.

How long do Humira side effects last?

Humira side effects will vary in onset and duration. Injection site or allergic reactions typically occur within minutes of the injection and last a few minutes to a few days. The first injection will always be performed by a healthcare professional in a clinical setting to monitor for possible allergic reactions. Other common side effects such as headache, sinus congestion, nausea, and flu or cold symptoms are also brief and can be treated with over-the-counter medications and rest.  

However, more serious side effects, such as liver problems, infections, and blood problems will take weeks or months to develop and may continue to worsen as long as Humira is taken. Severe infections, cancer, liver failure, heart problems, and auto-antibodies may have long-term or life-long consequences even after Humira is discontinued. Regular office visits and tests are necessary to monitor the longer-term effects of Humira.

Humira contraindications & warnings

Humira is not always the right medication for everyone. People with infections, latent infections, exposure to tuberculosis, a history of cancer, congestive heart failure, nerve disorders such as multiple sclerosis, liver disease, or allergies to the drug or any of its ingredients may not be suitable candidates for taking Humira.

Serious infections

Humira contains a black-box warning for serious infections. Humira will be discontinued if a serious infection, sepsis, or invasive fungal infection develops while taking the drug.  

Patients will need to be tested for tuberculosis before and during treatment with Humira. Any patient who tests positive for latent tuberculosis will require TB treatment before receiving Humira. The drug will be discontinued if a patient develops TB during treatment. 

Patients at risk for hepatitis B or histoplasmosis infections will also be tested before receiving Humira. Again, the drug will be discontinued if injections reactivate a latent hepatitis B infection.

Malignancies

Humira and other TNF blockers contain a black-box warning for malignancies, particularly lymphoma. Some patients on Humira and other TNF blockers have developed hepatosplenic T-cell lymphoma (HSTCL), an aggressive, rare, and often fatal type of lymphoma. Patients who have been treated for any cancer other than non-melanoma skin cancer may not be suitable candidates for treatment with Humira or similar TNF blockers. If a malignancy develops during treatment, Humira may be discontinued.   

Nervous system disorders

Patients with demyelinating disorders such as multiple sclerosis, Guillain-Barre syndrome, peripheral demyelinating disease, or optic neuritis may not be suitable candidates for Humira therapy. Demyelinating diseases are progressive nerve disorders that slowly strip away the protective sheath around nerve branches, decreasing their ability to pass nerve signals. Humira can cause flare-ups of any of these disorders, so Humira therapy will require constant monitoring in these patients.  

Congestive heart failure

Humira can worsen congestive heart failure, so patients with congestive heart failure will need to be monitored closely when taking Humira.  

Allergies

Patients with allergies to the drug, any of its ingredients, or rubber and latex may not be suitable candidates for Humira. The drug will be discontinued at any sign of a severe allergic reaction.

Pregnancy

Clinical data suggests that the relative risk of major birth defects is no higher in women treated with Humira versus those who are not. As a protein, Humira does pass through the placenta to the fetus. Few antibodies pass into the fetus during the first trimester, but the passage of antibodies steadily increases until it maximizes in the third trimester. Pregnant women may want to discuss with their doctors the risks and benefits of taking Humira during their pregnancy.

Breastfeeding

Humira is considered safe to take when breastfeeding infants. Humira does not appear to affect milk production or harm breastfeeding infants. Humira is present in breast milk but at one percent or less of its concentration in the bloodstream. It is also a protein, so it will be broken down in the infant’s digestive system. 

Abuse and dependence

Humira does not produce physical dependence or withdrawal symptoms. There are no known cases of Humira or other TNF blocker abuse.

Humira interactions

Some biologic immune-suppressing drugs should never be used with Humira because, in combination with Humira, these drugs dangerously suppress the immune system. Humira will not be prescribed in combination with the following immunosuppressants:

  • Orencia (abatacept)
  • Kineret (anakinra)
  • Remicade (infliximab)
  • Enbrel (etanercept)
  • Cimzia (certolizumab pegol)
  • Simponi (golimumab)

Humira may enhance the effects of other immune-suppressing or immune-modulating drugs, increasing the risk of infection and cancer. A doctor will exercise caution when prescribing Humira with:

  • Imuran (azathioprine)
  • Purinethol (6-mercaptopurine)
  • Cladribine
  • Rituxan (rituximab)
  • Xgeva (denosumab)
  • Ocrevus (ocrelizumab)
  • Actemra (tocilizumab)
  • Gilenya (fingolimod)
  • Mayzent (siponimod)
  • Daliresp (roflumilast)

Humira increases the toxicity and amplifies the side effects of certain medications, including the following:

  • Arava (leflunomide)
  • Ilaris (canakinumab)
  • Tysabri (natalizumab)
  • Entyvio (vedolizumab)
  • Prograf (tacrolimus)
  • Elidel (pimecrolimus)
  • Arcalyst (rilonacept) 

Humira reduces the therapeutic effects of some drugs such as warfarin, vaccines, and echinacea. Although there is no danger, the healthcare team may need to modify these other prescriptions or their dosing.

The manufacturer of Humira does not indicate that alcohol should be avoided. It is possible, then, that drinking alcohol in moderation while taking Humira is safe. This may not be true, however, for patients with liver problems. Humira can cause liver problems and—in very rare cases—liver failure, so consult with a doctor about drinking alcohol while taking Humira.

How to avoid Humira side effects

Most drugs cause side effects, so there is no guaranteed way to avoid side effects when taking medications. However, you can reduce the risk and severity of side effects with a few tips.

1.  Tell your doctor about all your medical conditions and medications

Because of the risk of serious side effects, you should tell your doctor about: 

  • Active or previous infections (particularly hepatitis B or tuberculosis)
  • A history of cancer, nervous system disorders (such as multiple sclerosis or Guillain-Barre syndrome), or heart failure
  • If you are pregnant or breastfeeding
  • Any medications or dietary supplements you may be taking, including over-the-counter medications
  • Recent or forthcoming vaccinations
  • Numbness, tingling, vision problems, or muscle weakness
  • Rubber or latex allergies

When taking Humira, inform your doctor immediately if you fall ill or get pregnant. Do not start taking any drug or dietary supplement until talking to your doctor first.

2.  Keep all follow-up medical appointments

Patients on Humira will be monitored to prevent serious side effects. This will require regular blood tests and office visits to catch problems before they develop into serious medical problems.

3.  Avoid infections

Humira makes patients more vulnerable to infections. To keep yourself safe, practice social distancing, wear a mask in public, avoid people with infections, wash your hands regularly, shower regularly, and carry and regularly use hand sanitizer. 

4.  Avoid live vaccines

You can receive vaccinations while taking Humira as long as they are not live vaccines. When given to immune-compromised patients, live vaccines not only carry a risk of causing an infection, the infection might spread throughout the entire body. Talk to a healthcare provider before taking a vaccine while taking Humira. The best practice is to get fully up-to-date on vaccines before starting Humira or any other immune-suppressing medication. When Humira is discontinued, wait at least two months before getting a live vaccine.

5.  Keep a list of all your medications

To reduce the risk of side effects and potentially hazardous drug-drug interactions, it is always a good idea to keep a list of all your medications updated at all times. Include any over-the-counter medications, vitamins, and herbal supplements that you take regularly. Always show that list when seeing your doctor or when filling a prescription. 

6.  Regularly switch the injection site

Humira’s most common side effects are injection site reactions. The easiest way to control injection site reactions is to change up the injection site with each injection. Humira is injected subcutaneously once every two weeks in the abdomen or thigh, so consider rotating the injection between each thigh and the abdomen. Avoid giving the injection into skin that is tender, irritated, red, swollen, bruised, or itchy. 

You might also reduce injection site reactions by removing the pre-filled syringe or pen injector from the refrigerator before the injection. Humira can be in a room temperature environment for up to 30 minutes prior to injection.  Make sure, however, it is not exposed to sunlight. Do not try to warm the medication in any other way.

7.  Ask your doctor about citrate-free Humira

Citric acid is a buffer that helps to keep injectable medications—particularly proteins such as Humira—stable over several months of storage. Citrate buffers, however, often cause significant pain for a few minutes after the injection. If Humira injection pain is too much to bear, ask your doctor about citrate-free Humira as an alternative. 

Related resources to Humira side effects:

Humira Pen subcutaneous: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

See also Warning section.

Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you develop signs of infection while using this drug, such as: sore throat that doesn’t go away, cough that doesn’t go away, fever, chills, night sweats, trouble breathing, painful or frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).

Tell your doctor right away if you have any serious side effects, including: fast/irregular/pounding heartbeat, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), blood in the stools, mental/mood changes, severe headache, easy bruising or bleeding, leg pain or swelling, numbness or tingling of the arms/hands/legs/feet, unsteadiness, unexplained muscle weakness, difficulty with speaking/chewing/swallowing/facial movements, vision changes, joint pain, butterfly-shaped rash on the nose and cheeks.

Adalimumab may rarely cause serious (possibly fatal) liver disease in people exposed to hepatitis B virus. Your doctor may order blood tests and watch for symptoms during treatment and for several months after your last treatment. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

Get medical help right away if you have any very serious side effects, including: seizures, chest pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Humira Warnings – Serious Infections, Cancers & Reactions

A black box warning in Humira’s label highlights the risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens. It also features cancers, notably lymphoma and hepatosplenic T-cell lymphoma.

Other warnings listed in Humira’s label include severe allergic reactions, hepatitis b reactivation, neurological reactions, blood reactions, worsening congestive heart failure and lupus-like syndrome.

Common Side Effects

One of the most common side effects of Humira is a reaction at the injection site. The U.S. Food and Drug Administration received reports of more than 10,000 cases of injection-site reactions related to the medication in 2014. Injection-site reactions include redness, rash, swelling, itching or bruising. Symptoms typically go away within a few days. However, patients should call a doctor immediately if they have pain, redness or swelling around the injection site that doesn’t go away within a few days or gets worse.

Sinusitis and upper respiratory infections are among the most commonly reported side effects of Humira.

During clinical trials involving nearly 1,400 people, 17 percent of patients treated with Humira reported upper respiratory infection compared with 13 percent of people who received a placebo. Another 11 percent of Humira-treated patients reported sinusitis while only 9 percent of people given the placebo reported the condition.

Headache and rash were each reported by 12 percent of Humira-treated patients. Eight percent and 6 percent of placebo-treated patients reported headache and rash, respectively.

Side Effects Humira (705 patients) Placebo (690 patients)
Upper Respiratory Infection 17% 13%
Sinusitis 11% 9%
Headache 12% 8%
Rash 12% 6%

Other reported side effects were flu syndrome, nausea, abdominal pain, abnormal laboratory tests, high amounts of cholesterol in the blood, high levels of fat particles in the blood, blood in urine, increased alkaline phosphatase, accidental injury, back pain, urinary tract infection and hypertension.

Serious Infections

Serious and even fatal infections are a recognized risk of Humira. These serious infections may be caused by viruses, fungi or bacteria. They can spread throughout the body and may lead to hospitalization and death.

Fact

The risk of serious infection may be even greater in patients who use Humira at the same time as other biologics.

The risk of serious infection may be even greater in patients who use Humira at the same time as other biologics, including Orencia (abatacept), Kineret (anakinra), Remcade (infliximab), Enbrel (etanercept), Cimzia (certolizumab pegol) or Simponi (golimuma). Some patients who were treated with rituximab (Rituxan) followed by TNF blockers also showed a higher rate of serious infections.

In addition to a tuberculosis (TB) warning, today’s Humira label carries a boxed warning for invasive fungal infections, such as histoplasmosis, as well as Legionella and Listeria infections. But that was not always the case. For years, Humira’s black boxed warning only included the risk of TB.

Tuberculosis (TB)

Humira’s black box warning clearly advises patients be tested for TB before starting Humira. Patients who test positive for TB should start treatment for the disease prior to starting Humira. Doctors should monitor all patients closely for signs and symptoms of TB during treatment with Humira, even if the initial latent TB test is negative.

Transmission electron microscopic (TEM) image of M.tuberculosis bacteria

“Cases of reactivation of tuberculosis and new onset tuberculosis infections have been reported in patients receiving Humira, including patients who have previously received treatment for latent or active tuberculosis,” according to the FDA.

Symptoms related to TB include a cough, fever, weight loss or loss of body fat and muscle. People considering Humira should let the prescribing doctor know if they have TB or have been in close contact with someone with TB. Also let the doctor know if the patient was born in, lives in or traveled to a place where there is more risk for getting TB.

Fact

In 2015, a Central Florida man filed a lawsuit, claiming he became paralyzed after using Humira.

According to the lawsuit, the man was given a shot of Humira and shortly thereafter began feeling numb from the waist down. He was then diagnosed with TB, according to the suit.

Invasive Fungal Infections

In September 2008, the FDA announced it would require makers of TNF blockers, like Humira, to highlight information about the risk of invasive fungal infections in a black box warning as well as in the warnings section of the drug’s prescribing information.

The agency notified health care professionals that it had received reports of people developing pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other infections while taking TNF blockers, such as Humira, and doctors were not consistently identifying the infections.

“In some patients, the diagnosis of histoplasmosis was initially unrecognized and antifungal treatment was delayed. Some of these patients died from histoplasmosis. There were also deaths in patients with coccidioidomycosis and blastomycosis.”

Legionella and Listeria Bacteria

In September 2011, the FDA announced it had added information about infection with Legionella and Listeria bacteria to the black box warning for all TNF blockers, including Humira.

The agency explained it had identified cases of Legionella pneumonia in people treated with TNF blockers. The FDA searched its Adverse Event Reporting System and identified reports of 80 patients who developed Legionella pneumonia between 1999 and 2010 after taking Humira or other TNF blockers. At least 14 people died.

Close-up illustration of Legionella Pneumophila bacteria

In addition, the FDA searched English-language medical literature and identified case reports of 23 patients who developed Legionella pneumonia after being treated with TNF blockers. Four patients experienced severe pneumonia requiring mechanical ventilation; five patients received treatment in a hospital intensive-care unit and three patients died.

The FDA has also received reports of people taking TNF blockers and developing serious infections due to Listeria monocytogenes. The agency searched English-language medical literature and identified 26 published cases of Listeria infection in patients treated with TNF blockers. Infections included meningitis, bacteremia, endophthalmitis and sepsis. There were seven reported fatalities.

“In addition, FDA identified fatal Listeria infections in a review of data regarding laboratory-confirmed infections that occurred in pre-marketing phase 2 and phase 3 clinical trials and from post-marketing surveillance,” the agency said.

Legionella and Listeria Risk

Many of the patients who developed Legionella pneumonia or Listeria infections had received immunosuppressive drugs, such as methotrexate and corticosteroids, at the same time as a TNF blocker.

Cancer

Children and adults taking Humira may have an increased risk of getting cancer. Specifically, patients taking TNF blockers have developed lymphoma, skin cancer (including basal cell and squamous cell) and leukemia. Some children, teenagers and young adults have developed hepatosplenic T-cell lymphoma, a rare, often fatal cancer of white blood cells.

Lymphomas, Leukemia and Melanoma

In June 2008, the FDA announced it was investigating 30 reports of cancer in children and young adults who were treated with TNF blockers for Juvenile Idiopathic Arthritis, Crohn’s disease or other diseases.

Fact

Use of TNF blockers is associated with an increased risk of lymphoma and other cancers in children and adolescents.

Reports of cancer were submitted to the FDA’s Adverse Event Reporting System over 10 years, beginning in 1998 — after the first TNF blocker hit the market — through April 29, 2008. The cases involved children and young adults who took TNF blockers with methotrexate, azathioprine or 6-mercaptopurine.

About half the cancers were lymphomas, including both Hodgkin’s and non-Hodgkin’s lymphoma; other cancers reported included leukemia, melanoma and solid organ cancers.

In a follow-up announcement in August 2009, the FDA said it had completed its analysis and concluded that there is an increased risk of lymphoma and other cancers associated with the use of TNF blockers in children and adolescents. The agency added the new safety information to the boxed warning for Humira and the other TNF blockers.

In addition, the FDA added new warnings about leukemia and new-onset psoriasis in patients treated with TNF blockers.

Hepatosplenic T-cell Lymphoma

The FDA put out two alerts in 2011 regarding TNF blockers and the development of cancer. First, in April, the FDA said it continued to receive reports of hepatosplenic T-cell lymphoma (HSTCL).

The reports were primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with TNF blockers as well as azathioprine and/or mercaptopurine. One patient was being treated for psoriasis and two patients were being treated for rheumatoid arthritis.

The FDA reviewed data from the Adverse Event Reporting System database, literature and the HSTCL Cancer Survivors’ Network and identified two cases of HSTCL with Humira and five cases with the combination of Humira and Remicade.

The cases were reported between the time TNF blocker marketing started and December 31, 2010. Of the five cases identified with the combination of Remicade and Humira use, four involved concomitant use of mercaptopurine or azathioprine.

FDA Announces ‘Enhanced Safety Surveillance’ for Humira

In a second 2011 safety communication, the FDA announced that it is requiring manufacturers of TNF blockers to “perform enhanced safety surveillance” for TNF blockers.

Enhanced surveillance allows the FDA to more completely capture and analyze malignancies in pediatric patients

As part of the enhanced safety surveillance, manufacturers must conduct in-depth follow-up of reports of cancer cases and submit all reports of cancer in pediatric and young adult patients to the FDA within 15 days of becoming aware of the report. The manufacturers must also provide annual summaries and assessments.

“This type of safety surveillance is important for our improved understanding of malignancies in pediatric and young adult patients treated with TNF blockers because it will allow [the] FDA to more completely capture and analyze all reported malignancies based on more complete and consistent reports,” the FDA said.

The agency says it will periodically re-evaluate the enhanced surveillance requirement through 2021.

Severe Allergic Reactions

People have experienced anaphylaxis (severe, life-threatening allergic reaction) and angioneurotic edema (swelling) following Humira administration.

Fact

Six percent of children with JIA and five percent of children with Crohn’s reported allergic reactions with Humira use during studies.

In clinical trials of Humira in adults, patients suffered allergic reactions, including allergic rash, anaphylaxis and urticarial (skin rash).

In a study of Humira in children with Juvenile Idiopathic Arthritis, 6 percent of patients suffered allergic reactions — including allergic rash — within the first 48 weeks of treatment. About 5 percent of patients in a study of Humira in children with Crohn’s disease suffered allergic reactions.

Signs of a serious allergic reaction include hives, trouble breathing, and swelling of the face, eyes, lips or mouth. Patients should call their doctor or get medical help immediately if they experience symptoms of an allergic reaction.

Hepatitis B Reactivation

People who carry hepatitis B virus (HBV) in their blood should be extra cautious when deciding whether to use Humira because the virus can become active during treatment.

“In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal,” according to Humira’s label. “The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation.”

Patients should undergo blood tests before, during and for several months after treatment with Humira.


It’s important to let the prescribing doctor know if the patient suffers from any of the following symptoms of a possible hepatitis B infection:

  • Muscle aches
  • Clay-colored bowel movements
  • Feeling very tired
  • Fever
  • Dark urine
  • Chills
  • Skin or eyes look yellow
  • Stomach discomfort
  • Little or no appetite
  • Skin rash
  • Vomiting

Neurological Reactions

Humira’s label warns consumers that the medicine has been associated with central and peripheral nervous system demyelinating disease. This includes multiple sclerosis (MS), optic neuritis and Guillain-Barré syndrome.

Some people experienced symptoms of these disorders for the first time following Humira use; others suffered from worsening of symptoms they already had.

“Exercise caution in considering the use of HUMIRA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders,” the Humira label states.

Blood Reactions

Though rare, some people have experienced blood reactions with use of TNF blockers, including Humira.

Humira’s label specifically warns of reports of pancytopenia, a condition in which the body has too few red blood cells, white blood cells and platelets.


Blood reactions reported with TNF use include:

Aplastic anemia
not enough new blood cells

Thrombocytopenia
not enough platelets in the blood

Leukopenia
not enough white blood cells

Signs and symptoms that may indicate blood dyscrasias or infection include persistent fever, bruising, bleeding and pallor. Anyone who experiences these symptoms while using Humira should contact a doctor.

Heart Failure

Humira may cause new heart failure or worsening of heart failure patients already have.

The drug’s label warns of cases of worsening congestive heart failure (CHF) with Humira, though the medicine has not been formally studied in patients with the condition.

Fact

Though the drug has not been formally studied in patients with the condition, Humira’s label warns of cases of worsening congestive heart failure.

Other Humira Warnings

Humira may cause immune reactions, including a lupus-like syndrome. Symptoms may improve when patients stop taking Humira, though they should not stop treatment without consulting a doctor. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain or a rash on the cheeks or arms that gets worse in the sun.

In addition, liver problems — including ones that can lead to liver failure and death — can happen in people who use TNF blockers, such as Humira. Symptoms of liver problems include fatigue, yellow-looking skin or eyes, poor appetite or vomiting, and pain on the right side of your stomach.

Some Humira users suffered new psoriasis or worsening of psoriasis they already had. Signs of psoriasis include red scaly patches or raised pus-filled bumps.

Adalimumab (Humira) and its biosimilars: medicine used for joint pain and inflammation

How to say adalimumab: AH-dah-lee-mu-mab.

Adalimumab is a biological medicine. It’s used to reduce inflammation by acting on your immune system.

Humira is the brand name of the original adalimumab medicine. There are now 5 new versions of adalimumab, known by the brand names Amgevita, Hulio, Hyrimoz, Idacio and Imraldi.

These new medicines are biosimilars. A biosimilar is a similar version of an original biological medicine.

Adalimumab biosimilars are equally safe and effective in reducing inflammation as Humira (the original adalimumab medicine).

All versions of adalimumab are used to treat inflammation of the:

  • joints (rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis)
  • skin (plaque psoriasis and hidradenitis suppurativa)
  • joints and skin (psoriatic arthritis)
  • spine, causing back pain (axial spondyloarthritis, including ankylosing spondylitis)
  • gut and ulcers in the lining of the gut (Crohn’s disease and ulcerative colitis)
  • the layer beneath the white of the eyeball (non-infectious uveitis)

Adalimumab is available on prescription. It comes as a pre-filled syringe or injection pen that you inject under the skin.

Your adalimumab will be delivered to your home by a homecare provider.

You’ll be shown how to use the injection by a homecare support nurse so you can give yourself or your child the injection at home.

You’ll need to store the injections in your fridge.

If you’re switching from Humira to an adalimumab biosimilar, the way the injection works might be different.

You can ask your specialist, homecare support nurse or pharmacist for training on the new injection if you need it.

If there are any changes to your homecare provider, you’ll be told before any changes are made.

Adalimumab Injection: MedlinePlus Drug Information

Using adalimumab injection may decrease your ability to fight infection and increase the chance that you will develop a serious infection, including severe fungal, bacterial, and viral infection that may spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores) or chronic infections that do not go away. Also tell your doctor if you have or have ever had any condition that affects your immune system or if you live or have ever lived in areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you don’t know if these infections are more common in your area. Tell your doctor if you are taking medications that decrease the activity of the immune system such as the following: abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), methotrexate (Otrexup, Rasuvo, Trexall), rituximab (Rituxan), or steroids such as dexamethasone, methylprednisolone (Medrol), prednisone (Rayos), or prednisolone (Prelone).

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: weakness; sweating; sore throat; cough; coughing up bloody mucus; fever; weight loss; extreme tiredness; diarrhea; stomach pain; warm, red, or painful skin; painful, difficult, or frequent urination; or other signs of infection.

You may already be infected with tuberculosis (TB; a serious lung infection) or hepatitis B (a virus that affects the liver) but not have any symptoms of the disease. In this case, adalimumab injection may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order a blood test to see if you have an inactive hepatitis B infection. If necessary, your doctor may give you medication to treat this infection before you begin your treatment with adalimumab. Tell your doctor if you have or have ever had TB, if you have lived in or visited a country where TB is common, or if you have been around someone who has or has ever had TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone,fever, or night sweats. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

Some children, teenagers, and young adults who received adalimumab injection or similar medications developed severe or life-threatening cancers including lymphoma (cancer that begins in the cells that fight infection). Some teenage and young adult males who took adalimumab or similar medications developed hepatosplenic T-cell lymphoma (HSTCL), a very serious form of cancer that often causes death within a short period of time. Most of the people who developed HSTCL were being treated for Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) with adalimumab or a similar medication along with another medication called azathioprine (Imuran) or 6-mercaptopurine (Purinethol). Tell your child’s doctor if your child has ever had any type of cancer. If your child develops any of these symptoms during his or her treatment, call his or her doctor immediately: stomach pain; fever; unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding. Talk to your child’s doctor about the risks of giving adalimumab injection to your child.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with adalimumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of using adalimumab injection.

Humira – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Adalimumab belongs to the class of medications called biological response modifiers (“biologics”) or TNF blockers (tumor necrosis factor blockers). It is used to treat:

  • moderate-to-severe rheumatoid arthritis
  • moderate-to-severely-active polyarticular juvenile idiopathic arthritis (pJIA) for children and adolescents from 2 to 17 years of age who have not responded adequately to other treatments
  • active psoriatic arthritis that has not responded to treatment with methotrexate
  • ankylosing spondylitis for adults who have not responded to other treatments
  • moderate-to-severe Crohn’s disease for adults who have not responded to other treatments
  • severely active Crohn’s disease for adolescents 13 to 17 years of age, who weigh more than 40 kg and  have not responded adequately to other treatments
  • moderate-to-severely active ulcerative colitis (UC) for adults who have not responded adequately to or cannot tolerate other treatments
  • moderate-to-severely active ulcerative colitis (UC) for children 5 years of age and older who have not responded adequately to or cannot tolerate other treatments
  • moderate-to-severe plaque psoriasis for adults
  • moderate-to-severe hidradenitis suppurativa (HS), an inflammatory disease of the skin, for adults and adolescents 12 years of age and older who weigh more than 30 kg and have not responded to treatment with antibiotics
  • non-infectious uveitis (an inflammatory disease of the eye) for adults who have not responded to corticosteroids, or to reduce the amount of corticosteroid needed
  • chronic non-infectious uveitis affecting the front of the eye for children over 2 years old who have not responded adequately to or cannot tolerate other treatments

People with these immune conditions produce extra amounts of an inflammatory protein called tumour necrosis factor alpha (TNF-alpha), causing pain, inflammation, and cellular damage. Adalimumab works by blocking the production of TNF-alpha to reduce the inflammation in the joints and on the skin. Depending on what condition adalimumab is being used to treat, it can take 4 to 12 weeks for you to notice an improvement in your condition.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Prefilled syringes

10 mg/0.1 mL
Each 0.1 mL of sterile solution for subcutaneous administration contains 10 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

20 mg/0.2 mL
Each 0.2 mL of sterile solution for subcutaneous administration contains 20 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

40 mg/0.8 mL
Each 0.8 mL of sterile solution for subcutaneous administration contains 40 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

80 mg/0.8 mL
Each 0.8 mL of sterile solution for subcutaneous administration contains 80 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

Prefilled pens

40 mg/0.8 mL
Each 0.8 mL of sterile solution for subcutaneous administration contains 40 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

80 mg/0.8 mL
Each 0.8 mL of sterile solution for subcutaneous administration contains 80 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

Vials (for pediatric use)
Each mL of sterile solution for subcutaneous administration contains 50 mg of adalimumab. Nonmedicinal ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium citrate, sodium chloride, sodium hydroxide (added as necessary to adjust pH), and water for injection.

How should I use this medication?

This medication is given by subcutaneous (under the skin) injection, usually in the front of the thigh or abdomen. The dose depends on the condition being treated.

For rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, the recommended dose for adults is 40 mg every other week.

For adults with Crohn’s disease or ulcerative colitis, the recommended dose is a first dose of 160 mg, then 80 mg 2 weeks after the first dose, then 40 mg every second week starting 4 weeks after the first dose.

For adults with psoriasis or uveitis, the recommended dose is a first dose of 80 mg, then 40 mg every other week starting one week after the first dose.

For children over 2 years old with uveitis, the dose of adalimumab is 20 mg every other week for children who weigh less than 30 kg and 40 mg every other week for children who weigh 30 kg or more. Your doctor may suggest a higher starting dose for children 6 years of age or older.

When treating polyarticular juvenile idiopathic arthritis for children over 2 years old, the dose of adalimumab is 20 mg every other week for children who weigh 10 kg to less than 30 kg. For children who weigh 30 kg or more, the dose is 40 mg given every other week.

For Crohn’s disease affecting children 13 to 17 years of age who weigh more than 40 kg, the recommended starting dose is 160 mg the first week, 80 mg given at week 2 and then 20 mg every second week, starting on week 4. The dose may be increased to 40 mg every other week depending on your child’s response. 

For ulcerative colitis affecting children aged 5 years and older the dose is based on body weight. Children who weigh less than 40 kg should receive a first dose of 80 mg, followed by 40 mg two weeks later, then at week 4 either 40 mg every second week or 20 mg every week. Children who weigh 40 kg or more receive a first dose of 160 mg, followed by 80 mg two weeks later, then starting week 4, either 80 mg every other week or 40 mg every week.

For adults with hidradenitis suppurativa, the recommended dose is a first dose of 160 mg, then 80 mg 2 weeks after the first dose, then 40 mg every week starting 4 weeks after the first dose. For adolescents 12 years of age and older who weigh more than 30 kg, the recommended dose is a first dose of  80 mg, then 40 mg every other week starting 1 week later.

Adalimumab is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject this medication on your own until you completely understand how to inject a dose. If you are having difficulty giving yourself injections, ask a family member or other caregiver for help if they are willing to become involved with your treatment and are willing to learn how to give you your injections.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, administer it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in the refrigerator at 2°C to 8°C, protect it from light, and keep it out of the reach of children. Do not allow it to freeze. The pen or pre-filled syringe may also be stored at room temperature (up to a maximum of 25°C) for a single period of 14 days. If it is stored at room temperature and is not used within 14 days, it must be discarded.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take adalimumab if you:

  • are allergic to adalimumab, latex, or any ingredients in the medication
  • have a severe infection such as sepsis, tuberculosis, or an opportunistic infection (infections that strike people with weakened immune systems)
  • have moderate-to-severe heart failure

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • headache
  • injection site reactions (redness, itching, bleeding, pain, or swelling)
  • nausea
  • skin rash
  • tiredness
  • upper respiratory infections (such as colds or sinus infections)
  • weakness
  • worsening appearance of a scar

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • arm or leg weakness or pain
  • breathing difficulty
  • chest pain
  • cold sores
  • cough
  • double vision
  • fever
  • flu-like symptoms
  • hair loss
  • joint pain
  • night sweats
  • numbness
  • scaly and red patches on the skin or skin bumps that are filled with pus
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
  • signs of heart problems (e.g., fast, irregular heartbeat or pulse; sudden weight gain; chest pain; difficulty breathing; swelling of the hands or feet [if there is no shortness of breath])
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of a urinary tract infection (pain or burning sensation when urinating, frequent urination, blood in the urine)
  • skin colour changes
  • sores in the mouth
  • a sore that doesn’t heal
  • symptoms of pneumonia (e.g., fever or chills, shortness of breath, fatigue, chest pain, cough)
  • tingling sensation
  • trouble swallowing
  • weight loss

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a severe allergic reaction (such as difficulty breathing, hives, swelling of the face or throat)
  • signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)
  • symptoms of a severe infection (such as fever, shaking or chills, fast heartbeat, quick breathing, confusion, skin rash)
  • swelling of the hands or feet with shortness of breath

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately. The needle cover on the prefilled syringe contains dry natural rubber. Before you start injections, tell your doctor if you have an allergy to rubber or latex.

Blood disorders: Rarely, people taking this medication have become deficient in certain types of blood cells. If you notice signs of anemia (dizziness, pale skin, unusual tiredness or weakness, shortness of breath), signs of infection (such as fever, shaking or chills, fast heartbeat, or quick breathing) or bleeding (such as easy bruising, blood in the stools, black tarry stools, or vomiting blood or material that looks like coffee grounds), seek immediate medical attention.

Cancer: Compared to the general population, people taking adalimumab have a slightly greater risk of developing a cancer of the immune system known as lymphoma. This appears to be more likely if infliximab, azathioprine, or mercaptopurine have also been used. However, the risk is still small. In general, people with severe rheumatoid arthritis who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don’t take adalimumab. If you experience any of the following or other unusual symptoms, contact your doctor immediately:

  • chills
  • decreased appetite
  • fever
  • night sweats
  • one or more enlarged lymph nodes
  • unusual fatigue
  • weight loss

Signs and symptoms of lymphoma can vary depending on the extent of the disease and the parts of the body involved (e.g., chest, abdomen, or bowel).

Dizziness: Adalimumab may cause dizziness and fatigue. Do not drive or operate machinery until you know that adalimumab does not affect your ability to perform these tasks safely.

Heart failure: Adalimumab may cause congestive heart failure (CHF) or worsen existing CHF. If you have CHF, you should be monitored closely by your doctors. Symptoms to watch for include swelling of the feet and ankles and shortness of breath. If you notice these symptoms, contact your doctor immediately.

Immune system disorders: Some people who take this medication have developed lupus-like syndrome, an autoimmune disease (a condition where the body is attacked by its own immune system). Symptoms of lupus-like syndrome include chest pain, joint pain, difficulty breathing, and a skin rash (usually on the cheeks and arms) that is sensitive to the sun. If you develop these symptoms, contact your doctor as soon as possible.

Infections: This medication or other TNF blockers can increase the risk of developing serious bacteria and fungi infections, such as tuberculosis and various types of pneumonia. If you notice signs of an infection such as fever, chills, pain, swelling, or pus, contact your doctor as soon as possible.

Tell your doctor if you have an infection or have a history of infections that keep coming back or other conditions that might increase your risk of infections, including fungal infections prior to initiating therapy. This medication should not be used in combination with anakinra, as this can increase the risk of severe infections.

People infected with hepatitis B virus (an infection that can damage the liver) may have a relapse of their condition while taking this medication. If you are at risk for hepatitis B, your doctor may test you for this infection before starting treatment with adalimumab and will follow your condition closely while you are taking the medication. If you notice symptoms of liver problems, such as abdominal pain, yellow eyes or skin, loss of appetite, fatigue, or dark urine, contact your doctor immediately.

Nervous system diseases: Rare cases of disorders that affect the nervous system have been reported by people taking adalimumab or other TNF blockers. If you are experiencing numbness and tingling, vision problems, weakness in your legs, and dizziness, contact your doctor immediately.

Surgery: There is little information regarding the safety of having surgical procedures if you are using adalimumab. You may be at an increased risk of developing infections after the surgery. Let all the medical professionals involved in your care know that you are taking adalimumab.

Vaccines: Live vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella) should not be given when you are taking adalimumab. Before starting treatment with this medication, check with your doctor to ensure your immunizations are up to date.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Contact your doctor if you become pregnant while taking adalimumab.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking adalimumab, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 2 years of age or who weigh less than 10 kg, for the treatment of JIA, or for the treatment of uveitis. The use of adalimumab to treat adolescents with Crohn’s disease should be limited to children who weigh more than 40 kg and are over 13 years old. Adalimumab should not be used to treat ulcerative colitis for children who are younger than 5 years of age. When children and teenagers have been treated with adalimumab, some have developed lymphoma (cancer of the immune system) and other types of cancer.

Seniors: People over the age of 65 years may be more at risk of side effects from this medication.

What other drugs could interact with this medication?

There may be an interaction between adalimumab and any of the following:

  • abatacept
  • anakinra
  • azathioprine
  • bacillus Calmette-Guérin (BCG)
  • baricitinib
  • belimumab
  • certolizumab
  • cladribine
  • cyclosporine
  • denosumab
  • echinacea
  • etanercept
  • fingolimod
  • golimumab
  • infliximab
  • leflunomide
  • mercaptopurine
  • natalizumab
  • ozanimod
  • rituximab
  • roflumilast
  • sarilumab
  • siponimod
  • tacrolimus
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • thioguanine
  • tocilizumab
  • tofacitinib
  • upadacitinib
  • vaccines
  • vedolizumab
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Humira

Memorial Sloan Kettering Cancer Center

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

Trade names: USA

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

Amgevita; Amgevita SureClick; Hadlima; Hadlima PushTouch; Hulio; Humira; Hyrimoz; Idacio

Warning

  • Very bad and sometimes deadly infections have happened in patients taking this drug.Most patients with these infections took other drugs to lower the immune system, such as methotrexate or steroid drugs. If you have any infection, are currently or recently taking antibiotics, or have had many infections in the past, consult your doctor.
  • Tuberculosis developed in people who start this drug. These patients have in the past been in contact with patients with tuberculosis, but they did not develop an infection.Before you start taking this drug, you need to get tested to see if you have had TB in the past.
  • Lymphoma and other malignant neoplasms have been reported in children and adolescents who have taken this or a similar drug. These neoplasms have also been found in adults. In some cases, this has been fatal. If you have any questions, please consult your doctor.
  • A rare cancer called liver and spleen T cell lymphoma (HSTCL) has been reported with this drug and other drugs of this nature.These cases were fatal. Almost all cases have been reported in people who have used drugs of this kind like 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 adolescent boys or young men. Consult your doctor.

What is this drug used for?

  • Used to treat some types of arthritis.
  • Used to treat Crohn’s disease.
  • This medication is used to treat ankylosing spondylitis.
  • It is used to treat plaque psoriasis.
  • It is used to treat ulcerative colitis.
  • Used to treat a skin disorder called purulent hydradenitis.
  • Used to treat uveitis.
  • This medicinal product can be used for other indications. Consult your doctor.

What should I tell my doctor BEFORE taking this drug?

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

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Tell your doctor and pharmacist about all the medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems. You need to make sure that this drug is safe for your medical 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 approval.

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

  • Tell all healthcare providers 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 often. Try not to come into contact with carriers of the infection, incl.h. with people with colds or flu.
  • If you have previously had hepatitis B or carry the virus, consult your doctor. Medicines of this type can activate the virus. This can lead to very serious, sometimes deadly, liver damage.
  • Hepatitis B testing should be done as directed by your doctor. Consult your doctor.
  • There is an increased likelihood of bleeding. Be careful and avoid injury.Use a soft toothbrush and electric shaver.
  • Before starting treatment with this drug, make sure you know about all the vaccines you have received so far.
  • Consult a physician prior to any vaccination. Using some vaccines with this drug may increase the chance of infection or make the vaccine less effective.
  • While using this drug, weakened bacteria such as BCG should not be administered to treat bladder cancer.Please consult your doctor.
  • Perform blood tests as directed by your doctor. Please consult your doctor.
  • If you are allergic to latex, consult your doctor. Some products contain latex.
  • If you have sunburn or other skin problems, consult your doctor.
  • Get a skin examination. Tell your doctor if you have any skin changes, such as a new wart, a skin sore, or a reddish bleeding or non-healing swelling, or a change in the color or size of a mole.
  • The use of such drugs was occasionally accompanied by the appearance of disorders of the nervous system in patients. Sometimes these violations did not disappear. Call your doctor right away if you have an abnormal burning, numbness, or tingling sensation, blurred vision, dizziness, cramps, or weakness in your arms or legs.
  • Cases of dangerous abnormalities in blood cell levels have occurred, such as aplastic anemia and a variant of low leukocyte counts.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 have 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.
  • If you used this drug while pregnant, tell your child’s doctor.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, some people with this drug can cause serious and sometimes deadly side effects. Call your doctor or get medical help right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

  • Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with 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 severe sore throat, ear, or sinuses, cough, increased or discolored phlegm, pain when urinating, mouth ulcers, or an open wound.
  • Signs of a urinary tract infection, including blood in the urine, burning or painful sensations when urinating, 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, rapid sunburn, muscle or joint pain, chest pain or shortness of breath, and swelling of the arms and legs.
  • Signs of high blood pressure, such as very severe headache, or dizziness, or loss of consciousness, or blurred vision.
  • High temperature that does not drop.
  • Swelling or overgrowth of the skin.
  • Pale skin.
  • Red, rough spots or blisters filled with pus.
  • Get immediate medical attention if you develop symptoms such as swollen lymph nodes, night sweats, shortness of breath, or unexplained weight loss.
  • Liver dysfunctions have been reported while taking drugs of this kind. Sometimes these cases were fatal. Call your doctor right away if you have signs of liver dysfunction, such as dark urine, tired feeling, lack of appetite, nausea or abdominal pain, light colored stools, vomiting, yellow skin or eyes.
  • Cases of heart failure and worsening of previous heart failure have been reported with this drug.Talk to your doctor if you have a heart condition. If you experience shortness of breath, a sudden increase in body weight, an irregular heartbeat, swelling of the hands and feet, 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, many people have little or no side effects. Call your doctor or get medical help 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.
  • Injection site irritation.

This list of potential 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 Office.

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 healthcare practitioner. Read all the information provided to you. Follow all instructions strictly.

All forms of issue:

  • It is injected into the subcutaneous fat of the upper thigh or abdomen.
  • If you give yourself injections, your doctor or nurse will teach you how to inject.
  • Wash 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 if shaking of this drug is allowed.
  • Do not use if solution is cloudy, leaking, or contains particles.
  • Do not inject into the skin within 2 inches (5 cm) of the navel.
  • Do not apply to areas of soreness, bruising, redness or hardening of the skin.
  • Change the injection site with each injection.
  • To make the injection easier to transfer, remove the drug from the refrigerator and keep at room temperature for 30 minutes before use. Do not remove the cover or cap. Do not heat the preparation.
  • Depending on the brand of this drug, it can be transparent 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.
  • Dispose of needles in the 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 questions, ask your doctor or pharmacist.

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

  • The syringe should be discarded after one use.Do not use the syringe more than once.

Vials:

  • Discard all unused portions from the opened ampoule after injection.

What should I do if a dose of a drug is missed?

  • Take the missed dose as soon as you can.
  • If it is time for your next dose, do not take the missed dose and then return to your normal dose.
  • Do not take 2 doses at the same time or an additional dose.
  • If you miss a dose and are not sure what to do, contact your doctor.

How do I store and / or discard this drug?

  • Store in refrigerator. Do not freeze.
  • Do not use this medicine if it has been frozen.
  • Store in original packaging to protect from light.
  • If necessary, after mixing, the drug can be stored at room temperature for up to 14 days.Write down the date you took this drug out of the refrigerator. Discard if this drug is stored at room temperature without use for 14 days.
  • Protect from heat.
  • Store 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 toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

  • If your health does not improve or even worsens, see your doctor.
  • You should not give your medicine to anyone and take other people’s medicines.
  • Some medicines may have different patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
  • A separate patient instruction sheet is attached to the product. Please read this information carefully. Reread it every time you replenish your supply. If you have questions about this drug, talk with your doctor, pharmacist, or other healthcare professional.
  • If you think there has been an overdose of a drug, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are suitable for a particular patient.This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient. Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional.Check with your doctor for complete information on the possible risks and benefits of taking this drug. Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

90,000 Humira Side Effects and How to Avoid Them | SingleCare – Product Information

Product Information

Humira Side Effects | How long do the side effects last? | Warnings | Interactions | Avoiding Side Effects

Humira (adalimumab) – injection of a natural human antibody – induces remission and controls the symptoms of active autoimmune diseases.A healthcare provider may prescribe Humira for rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, uveitis, and purulent hydradenitis. In all of these conditions, flare-ups occur when the immune system mistakenly attacks healthy tissue.

Humira suppresses the body’s immune response by blocking a chemical produced by the body – tumor necrosis factor or TNF – that causes edema.As with all medicines, the decision to take Humira must take into account the benefits and risks of the medicine, so it is important to talk with your doctor about the side effects, drug interactions and warnings associated with this medicine.

RELATED TO: Learn more about Humira | Get Discounts on Humira

Common Side Effects Humira

Humira suppresses the immune system, so infections and malignancies are common and can also cause serious side effects.In addition, with subcutaneous injection, Humira causes a reaction at the injection site after about 1 in 5 patients. The most common side effects of Humira are:

  • Injection site reactions (redness, swelling, pain, itching and rash)
  • Upper respiratory tract infections
  • Sinus congestion
  • Headache
  • Development of autoimmune antibodies
  • Rashes
  • Nausea
  • Abdominal pain
  • Liver dysfunction
  • Urinary tract infection
  • Flu or cold symptoms
  • Back pain
  • Increased blood fat
  • Increased serum cholesterol
  • High blood pressure 6

9000 Is Humira Hair Loss Or Weight Gain?

In very rare cases, Humira can cause hair loss.

However, unexplained weight loss or weight gain is not directly caused by Humira. However, its active ingredient increases the risk of lymphoma, leukemia and other cancers, many of which are characterized by loss of appetite and involuntary weight loss. See your doctor right away if you notice weight loss, decreased appetite, or satiety with a small amount of food while taking Humir.

Serious Side Effects of Humira

Because Humira suppresses the immune system, patients are at increased risk of serious and even life-threatening infections and cancer.As with any antibody injection, there is a risk of allergic reactions. Most serious side effects of Humira:

  • Serious or life-threatening infections
  • Cancer (lymphoma, leukemia, non-melanoma skin cancer and other malignant neoplasms)
  • Severe or life-threatening allergic reactions.
  • Reactivation of tuberculosis or hepatitis B virus
  • Aggravation or onset of nervous system disorders such as multiple sclerosis or optic neuritis
  • Heart problems (atrial fibrillation, tachycardia, cardiac arrhythmia, chest pain, heart attack)
  • congestive heart failure
  • Lupus syndrome
  • Low blood cell count or anemia
  • Liver damage or failure
  • Gallstones
  • Cataracts
  • Arthritis
  • Muscle weakness
  • Confusional

and you should stop taking Humira Seek medical attention immediately if you experience any of the following adverse reactions while taking Humira:

  • Fever, fatigue, loss of appetite, abdominal pain, etc.D. signs of hepatitis B infection .
  • Swollen glands, fatigue, fever, chills, night sweats, loss of appetite, involuntary weight loss, unexplained bumps on the skin, easy bruising or bleeding, etc. General signs of cancer .
  • Hives, facial swelling, blisters, purplish skin, shortness of breath, drop in blood pressure, dizziness, fainting, etc. Signs of a severe allergic reaction or anaphylaxis .
  • Fatigue, fever, joint pain, facial rash, skin lesions caused by sunlight, shortness of breath, etc. signs of lupus syndrome .
  • Rapid heartbeat, heart palpitations, chest pain, etc. signs of cardiac dysfunction .

Humira injection may be discontinued if any of these conditions occur.

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You should talk to your doctor immediately about stopping Humira if you experience:

  • Fever, cough, edema, chills, swollen glands, loss of appetite, abdominal pain, etc.D. signs of infection .
  • Weakness, fatigue, pallor of the skin, heart palpitations, easy bruising or bleeding, etc. signs of blood problems .
  • Yellow skin, yellowing of the eyes, pain in the upper right corner of the abdomen, bloating, disorientation, etc. signs of acute liver problems .
  • Muscle weakness, vision changes, muscle stiffness, muscle spasms, tingling, numbness, etc. Signs Nervous system disorders .

Humira is prescribed only once every two weeks, so doctors and patients have time to re-evaluate Humira in the face of side effects.

How long do Humira side effects last?

Humira side effects will vary in onset and duration. At the injection site or allergic reactions usually occur within minutes after injection and last from a few minutes to several days. The first injection is always performed by a healthcare professional in a clinical setting to monitor for possible allergic reactions.Other common side effects, such as headache, sinus congestion, nausea, and flu or cold symptoms, are also short-lived and can be treated with over-the-counter medications and rest.

However, more serious side effects such as liver problems, infections, and blood problems can develop after weeks or months and may continue to get worse while Humira is taken. Severe infections, cancer, liver failure, heart problems, and autoantibodies can have long-term or lifelong consequences even after you stop taking Humir.Regular office visits and tests are necessary to monitor the long-term effects of Humira.

Humira contraindications and warnings

Humira is not always suitable for everyone. People with infections, latent infections prone to tuberculosis, a history of cancer, congestive heart failure, nervous disorders such as multiple sclerosis, liver disease, or an allergy to the drug or any of its ingredients may not be suitable for Humir.

Serious Infections

Humira contains a black box warning for serious infections. Humira will be discontinued if a serious infection, sepsis, or invasive fungal infection develops while taking the drug.

Patients will need to be screened for tuberculosis before and during treatment with Humira. Any patient who tests positive for latent TB will need treatment for TB before taking Humir.The drug will be canceled if the patient develops tuberculosis during treatment.

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Patients at risk of contracting hepatitis B or histoplasmosis will also be screened before taking Humira. Again, the drug will be discontinued if the injections reactivate latent hepatitis B infection.

Malignant neoplasms

Humira and other TNF blockers contain a black box warning for malignancy, especially lymphoma.Some patients taking Humira and other TNF blockers have developed hepatosplenic T-cell lymphoma (HSTCL), an aggressive, rare, and often fatal type of lymphoma. Patients who have been treated for any cancer other than non-melanoma skin cancer may not be suitable candidates for treatment with Humira or similar TNF blockers. If a malignant neoplasm develops during treatment, Humira may be discontinued.

Nervous System Disorders

Patients with demyelinating disorders such as multiple sclerosis, Guillain-Barré syndrome, peripheral demyelinating disease, or optic neuritis may not be suitable candidates for Humir therapy.Demyelinating diseases are progressive nerve disorders that slowly destroy the protective sheath of nerve branches, impairing their ability to transmit nerve signals. Humira can exacerbate any of these diseases, so Humira’s therapy will require constant monitoring in these patients.

Chronic heart failure

Humira can aggravate congestive heart failure, therefore patients with congestive heart failure should be closely monitored when taking Humira.

Allergies

Patients who are allergic to the drug, any of its ingredients or rubber and latex may not be suitable for Humir. The drug will be discontinued if any signs of a severe allergic reaction appear.

Pregnancy

Clinical data show that the relative risk of serious birth defects is not higher in women who received Humira compared to those who did not. Like a protein, Humira crosses the placenta to the fetus.Few antibodies penetrate the fetus during the first trimester, but the passage of antibodies increases steadily until it peaks in the third trimester. Pregnant women can discuss with their doctors the risks and benefits of taking Humira while pregnant.

Breastfeeding

Humira is considered safe for breastfeeding. Humira does not affect milk production and does not harm breastfeeding. Humira is present in breast milk but accounts for one percent or less of its concentration in the bloodstream.It is also a protein, so it is broken down in the baby’s digestive system.

Abuse and Dependence

Humira does not cause physical dependence or withdrawal symptoms. There are no known cases of abuse of Humira or other TNF blockers.

Humira interactions

Certain immunosuppressive biological drugs should never be used with Humira because these drugs can dangerously suppress the immune system when combined with Humira.Humira will not be prescribed in combination with the following immunosuppressants:

  • Orencia (abatacept)
  • Kineret (anakinra)
  • Remicade (infliximab)
  • Enbrel (etanercept)
  • Cimzia (certolizumab gol1725 pegumabol)
  • Humira may enhance the effects of other immunosuppressive or immunomodulatory drugs, increasing the risk of infections and cancer. The physician will carefully prescribe Humir along with:

    • Imuran (azathioprine)
    • Purinethol (6-mercaptopurine)
    • Cladribine
    • Rituxan (rituximab)
    • Xgeva (denosumab)
    • Okrevus) (ocrelizuma)
    • Gilenga (fingolimod)
    • Mayzent (siponimod)
    • Dalirep (roflumilast)

    Humira increases toxicity and side effects of some drugs, including the following:

    • Arava (leflunomide)
    • Ilaris (canakinumabis)
    • Ilaris (canakinumabis) (natalizumab)
    • Entivio (vedolizumab)
    • Prograf (tacrolimus)
    • Elidel (pimecrolimus)
    • Arcalist (rilonacept)

    Humira reduces the therapeutic effects of certain drugs such as warfarin, vaccines and echinacea.Although there is no danger, medical personnel may need to change these other prescriptions or their dosage.

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    The manufacturer Humira does not indicate that alcohol should be avoided. Thus, it is possible that moderate alcohol consumption while taking Humir is safe. However, this may not be true for patients with liver problems. Humira can cause liver problems and, in very rare cases, liver failure, so consult your doctor about drinking alcohol while taking Humira.

    Avoiding side effects of Humira

    Most drugs cause side effects, so there is no guaranteed way to avoid side effects when taking medication. However, you can reduce the risk and severity of side effects with a few tips.

    1. Tell your doctor about all your medical conditions and medications.

    Because of the risk of serious side effects, you should inform your doctor about:

    • Active or previous infections (especially hepatitis B or tuberculosis)
    • History of cancer, nervous system disorders (such as multiple sclerosis or Guillain-Barré syndrome ) or heart failure.
    • If you are pregnant or breastfeeding
    • Any medicine or dietary supplement you are taking, including over-the-counter medicines.
    • Recent or upcoming vaccinations
    • Numbness, tingling, vision problems or muscle weakness
    • Allergy to rubber or latex

    While taking Humira, tell your doctor right away if you get sick or become pregnant. Do not start taking any medications or dietary supplements until you talk to your doctor first.

    2. Observe all following medical procedures.

    Patients taking Humira will be monitored to prevent serious side effects. This will require regular blood tests and office visits to identify problems before they develop into serious health problems.

    3. Avoid infections.

    Humira makes patients more vulnerable to infections. To stay safe, practice social distancing, wear a mask in public, avoid people with infections, wash your hands regularly, shower regularly, wear and use hand sanitizer regularly.

    4. Avoid live vaccines.

    You can get vaccines while taking Humir if they are not live vaccines. When given to immunocompromised patients, live vaccines not only carry the risk of infection, but can spread throughout the body. Talk to your doctor before giving the vaccine while taking Humir. It is best practice to get complete information on vaccines before taking Humir or any other immunosuppressive medication.After you stop taking Humira, wait at least two months before giving the live vaccine.

    5. List all of your medications.

    To reduce the risk of side effects and potentially dangerous drug interactions, it is recommended that you keep your list of all your medicines up to date. Include all over-the-counter medicines, vitamins, and herbal supplements that you take regularly. Always show this list when you visit your doctor or get a prescription.

    6. Change the injection site regularly.

    The most common side effects of Humira are injection site reactions. The easiest way to control the reaction at the injection site is to change the injection site with each injection. Humira is injected subcutaneously once every two weeks into the abdomen or thigh, so consider alternating injections between each thigh and abdomen. Avoid injecting into tender, irritated, red, swollen, bruised, or itchy skin.

    You can also reduce the injection site reaction by removing the pre-filled syringe or pen from the refrigerator prior to injection. Humira can be kept at room temperature for up to 30 minutes before injection. However, make sure it is not exposed to sunlight. Do not try to rewarm the medicine in any other way.

    7. Ask your doctor about Humira Citrate Free.

    Citric acid is a buffer that helps maintain the stability of injectables, especially proteins such as Humira, over several months of storage.However, citrate buffers often cause significant pain within minutes of injection. If the pain from Humira’s injection is unbearable, ask your doctor about Humira’s citrate-free alternative.

    Resources related to Humira side effects:

    Composition, indications, dosage, side effects

    It is an immunosuppressant. It is a recombinant human immunoglobulin (IgG1), monoclonal antibody. Inhibits tumor necrosis factor-alpha.

    Composition and release form

    Active ingredient: adalimumab (20 mg / 0.2 ml, 40 mg / 0.4 ml, 40 mg / 0.8 ml).

    Humira is produced in the form of an injection solution.

    Readings

    Humira Shown:

    – for rheumatoid arthritis;

    – with psoriatic arthritis;

    – with axial spondyloarthritis;

    – with ankylosing spondylitis;

    – with Crohn’s disease;

    – with ulcerative colitis;

    – with plaque psoriasis;

    – with purulent hydradenitis;

    – with uveitis;

    – with juvenile rheumatoid (idiopathic) arthritis;

    – with enthesitis-associated arthritis.

    Contraindications

    Humira’s drug is not used:

    – with intolerance to the components;

    – with active tuberculosis, other severe infections such as sepsis, opportunistic infections;

    – with moderate / severe heart failure (III-IV class NYHA).

    Application during pregnancy and lactation

    Adalimumab crosses the placenta, enters the blood of the embryo. These children may have an increased risk of infection.Live vaccines are contraindicated for newborns whose mothers received the drug during pregnancy within five months of the last injection.

    Humira can be used during breastfeeding.

    Route of administration and doses

    Humira is administered parenterally.

    The treatment regimen must be prescribed by a doctor. The advisability of continuing therapy should be reconsidered if no response to treatment is observed within the specified period.If necessary, therapy is interrupted (for example, in case of severe infection, before surgery).

    The standard adult dose for rheumatoid arthritis is 40 mg subcutaneously every two weeks. A clinical response is usually achieved within 12 weeks of therapy.

    The standard dose for axial spondyloarthritis, psoriatic arthritis for adults is 40 mg subcutaneously every two weeks. A clinical response is usually achieved within 12 weeks of therapy.

    The standard dose for Crohn’s disease for the induction of remission is 80 mg once a week (at the 1st week of treatment), followed by a dose reduction to 40 mg per week (at the 2nd week).If a quick clinical response is needed, first use 160 mg per week in the form of 4 injections per day or two injections for two days in a row, in the second week, use a dose of 80 mg subcutaneously. After induction therapy, a maintenance dose is prescribed – subcutaneously 40 mg every 2 weeks.

    The standard dose for ulcerative colitis to induce remission in adults is 160 mg in the first week, then 80 mg after 2 weeks. After induction therapy, 40 mg is recommended once every two weeks.A clinical response is usually achieved within 2-8 weeks of therapy.

    The standard dose for plaque psoriasis is 80 mg subcutaneously per week, maintenance dose is 40 mg every 2 weeks.

    The standard dose for purulent hydradenitis is 160 mg per week (in the form of 4 injections per day or 2 injections per day for two days in a row), then – 80 mg in 2 weeks (in the form of 2 injections per day). After two weeks, 40 mg is prescribed once a week. The advisability of continuing therapy after 12 weeks of treatment should be reconsidered if no clinical response is observed within this period.

    The standard dose for uveitis is 80 mg subcutaneously per week, followed by a maintenance dose of 40 mg every two weeks.

    In pediatrics, the recommended dose for children from 2 years of age depends on body weight. The prescribed dose is administered subcutaneously once every two weeks.

    Overdose

    Symptoms are not described.

    In case of overdose, it is recommended to monitor the patient, conduct appropriate symptomatic therapy.

    Side effects

    Infections / invasions: respiratory tract infections (pneumonia, rhinopharyngitis, sinusitis, pharyngitis), systemic infections (sepsis, flu, candidiasis), intestinal infections (incl.including viral gastroenteritis), soft tissue and skin infections (paronychia, impetigo, cellulitis, herpes zoster, necrotizing fasciitis), ear infections, genital infections (fungal vulvovaginitis), oral infections, urinary tract infections (pyelonephritis), joint infections, opportunistic infections (coccidioidomycosis, mycobacterium avium complex infections, histoplasmosis), tuberculosis, eye infections, neurological infections (viral meningitis), bacterial infections.

    Hematological disorders: leukopenia (neutropenia, agranulocytosis), anemia, leukocytosis, thrombocytopenia, pancytopenia, idiopathic thrombocytopenic purpura.

    Benign, malignant, nonspecific neoplasms: skin cancer (melanoma, basal cell carcinoma, squamous cell carcinoma), lymphoma, breast cancer, lung tumors, thyroid tumors.

    Immune disorders: allergies.

    Metabolic disorders: hyperuricemia, hyperlipidemia, hypokalemia, dysnatremia, hypocalcemia, hypophosphatemia, hyperglycemia, dehydration.

    Mental disorders: mood changes (incl.including depression), insomnia, anxiety.

    Neurological disorders: migraine, paresthesia (including hypesthesia), multiple sclerosis, compression of nerve roots, tremor, neuropathy.

    Ophthalmic disorders: impaired visual acuity, blepharitis, conjunctivitis, eye edema, diplopia.

    Otolaryngological disorders: deafness, vertigo, ringing in the ears.

    Cardiovascular disorders: tachycardia, chronic heart failure, arrhythmia, cardiac arrest, arterial hypertension, hematoma, hot flashes, arterial occlusion, aortic aneurysm, thrombophlebitis.

    Respiratory disorders: pneumonitis, cough, asthma, COPD, shortness of breath, interstitial lung disease.

    Gastrointestinal disorders: abdominal pain, vomiting, gastrointestinal bleeding, gastroesophageal reflux, dyspepsia, Sjogren’s syndrome, pancreatitis, dysphagia, facial edema.

    Hepatobiliary disorders: cholecystitis, cholelithiasis, hyperbilirubinemia, hepatic steatosis.

    Dermatological disorders: exfoliative rash, pruritus, dermatitis, urticaria, ecchymosis, eczema, onychoclasia, sweating, scars.

    Musculoskeletal disorders: musculoskeletal pain, rhabdomyolysis, muscle spasms, systemic lupus erythematosus.

    Urinary disorders: nocturia, hematuria, renal failure.

    Sexual dysfunction: erectile dysfunction.

    Others: slow wound healing, chest pain, swelling, inflammation, redness at the injection site.

    Changes in laboratory data: positive tests for autoantibodies, disorders of the blood coagulation system, increased levels of lactate dehydrogenase in the blood.

    Terms and conditions of storage

    Store Humira at temperatures from +2 to + 8 ° C (in the refrigerator) for no more than 2 years.

    Humira (Adalimumab), Humira (Adalimumab)

    Humira’s drug is a selective immunosuppressive agent. It is a recombinant monoclonal antibody. The principle of action of the drug is to neutralize the functions of TNFα. TNFα plays an important role in the development of pathological inflammation and destruction of the articular tissue. Humir’s injections are recommended for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis.In the treatment of psoriasis, taking Humira leads to a decrease in the thickness of plaques and infiltration in inflammatory cells. Combinatorial therapy with methotrexate and other antirheumatic drugs is recommended.

    Method of administration of the drug Humira

    Treatment is carried out under the supervision of a physician. Standard dosage is an injection of 1 adalimumab with a syringe once every 14 days. Adalimumab is excreted slowly, clearance usually does not exceed 12 ml / h. T1 / 2 averages 2 weeks and varies from 10 to 20 days.It is recommended to combine therapy with taking medications with a modifying effect.

    Injections are injected into the thigh or abdomen. The solution should be inspected prior to administration for foreign particles and discoloration. Should not be mixed in the same syringe or vial with any other medicines. The remaining solution and used materials must be disposed of.

    Injections are carried out according to the schedule, which is made by the doctor. Do not miss taking the product.If you deviate from the reception mode, you must resume injections as soon as this has happened. The next injection should be carried out according to the previously planned schedule.

    Indications for taking Humira

    The drug Humira is recommended for treating patients of different age groups.

    Indications for Humir injections for adults:

    • moderate to severe active rheumatoid arthritis;
    • active psoriatic arthritis;
    • active ankylosing spondylitis;
    • Crohn’s disease;
    • chronic plaque psoriasis;
    • moderate to severe ulcerative colitis;
    • axial spondyloarthritis;
    • active purulent hydradenitis of moderate or severe degree.

    Indications for treatment with the drug for children:

    • juvenile idiopathic arthritis in patients over 2 years of age in monotherapy or in combination with methotrexate;
    • Crohn’s disease (moderate and severe) in patients aged 6 years and older with an inadequate response to traditional therapy, as well as intolerance or contraindications to traditional therapy;
    • active enthesitis-associated arthritis in patients aged 6 years and older in the absence of an adequate response to therapy with standard medications or in case of their intolerance.

    Contraindications to Humira’s injections

    When taking the drug Humira, allergic reactions in the area of ​​the injection of varying severity are observed. Contraindications to injections in different groups of patients are individual. The use of the drug should not be started by patients with acute infectious diseases, patients with tuberculosis, and allergy sufferers. Pregnant women should refrain from injections; in this case, the doctor prescribes therapy with other medications.

    Other contraindications:

    • children under 18 years of age;
    • joint administration with TNF antagonists or other genetically engineered biological antirheumatic agents;
    • history of recurrent infections;
    • carriage of hepatitis B virus;
    • malignant neoplasms;
    • heart failure;
    • demyelinating diseases of the nervous system;
    • 90,017 patients over 65 years of age.

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    Humira Vial in Russian – Item

  • Can Humira Vial be used for Ankylosing Spondylitis and Rheumatoid Arthritis?

    Yes, ankylosing spondylitis and rheumatoid arthritis are among the most common reported uses for Humira Vial. Please do not use Humira Vial for ankylosing spondylitis and rheumatoid arthritis without consulting first with your doctor.Click here and view the survey results to find out exactly how other users are using Humira Vial.

  • Should I use this product empty stomach, before food or after food?

    TabletWise.com website users have most commonly reported using Humira Vial after food. However, this information may not be appropriate for your specific situation. Please consult your healthcare professional for an appointment schedule.Click here and view the survey results to see what other users have to say about the best time to take Humira Vial.

  • Is it safe to drive or operate heavy equipment while using this product?

    If you feel drowsiness, dizziness, hypotension or headache while taking Humira Vial, you may need to stop driving and heavy industrial equipment.You should stop driving if taking the drug makes you drowsy, dizzy, or hypotensive. Doctors recommend to stop drinking alcohol with such drugs, because alcohol significantly increases side effects and drowsiness. Please check your body’s response when taking Humira Vial. Be sure to contact your healthcare professional for advice based on your body and overall health.

  • Is this medication (product) addictive or addictive?

    Most drugs are not addictive or addictive.In most cases, the government classifies drugs that can be addictive as controlled dispensing drugs. For example, the H or X chart in India and the II-V chart in the USA. Please review the information on the drug packaging to make sure this drug is not a controlled drug. Also, do not self-medicate or train your body to medication without consulting your healthcare professional.

  • Can I stop using this product immediately or do I need to slowly stop using it?

    Some drugs need to be stopped gradually due to the recovery effect.