Generic Name: adalimumab (AY-da-LIM-ue-mab)
Brand Name: Humira
Patients who use adalimumab have an increased risk of developing serious and sometimes fatal infections (eg, bacterial, viral, or fungal infections; tuberculosis [TB]). Most patients who developed these infections were also taking medicine that suppressed their immune system (eg, corticosteroids, methotrexate).
TB may be caused by a new infection or by reactivation of a previous infection. Patients should receive a TB skin test before using adalimumab. Patients who test positive for TB should begin treatment for TB before starting adalimumab. All patients should also be monitored for signs of TB while using adalimumab, even if their TB test is negative.
Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle aches or weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin or sores; diarrhea or stomach pain; increased or painful urination).
Adalimumab is a tumor necrosis factor (TNF) blocker. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF blockers. This has been fatal in some cases. Talk with your doctor for more information.
A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has been reported in patients using TNF blockers, including adalimumab. These cases have been fatal. Most of these cases occurred in teenagers or young adults, and most of these patients had Crohn disease or ulcerative colitis. Patients who developed this cancer were usually using adalimumab along with certain other medicines (azathioprine, 6-mercaptopurine). Tell your doctor if you have or have ever had any type of cancer.
Adalimumab is used for:
Treating a variety of moderate to severe inflammatory conditions (eg, rheumatoid arthritis, juvenile idiopathic arthritis [JIA], psoriatic arthritis, ankylosing spondylitis). It is also used to treat certain patients with moderate to severe Crohn disease, ulcerative colitis, or chronic plaque psoriasis. It may be used alone or in combination with other medicine. It may also be used for other conditions as determined by your doctor.
Adalimumab is a TNF blocker. It works by blocking a protein (TNF-alpha) found in the body that causes inflammation.
Do NOT use adalimumab if:
- you are allergic to any ingredient in adalimumab
- you have a severe infection (eg, sepsis) or any other active infection
- you are using abatacept, anakinra, or another TNF blocker (eg, certolizumab, etanercept, infliximab)
Contact your doctor or health care provider right away if any of these apply to you.
Before using adalimumab:
Some medical conditions may interact with adalimumab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances, including rubber or latex
- if you have a history of an infection that keeps coming back, TB infection, or positive TB skin test
- if you have a history of hepatitis B infection or other liver problems; heart problems (eg, heart failure); high cholesterol; high blood pressure; diabetes; cancer (eg, lymphoma); blood problems; bone marrow problems; an autoimmune disorder (eg, lupus); other immune system problems (eg, weakened immune system); or numbness, tingling, or other nervous system problems (eg, multiple sclerosis [MS], optic neuritis, Guillain-BarrÃ© syndrome, seizures)
- if you have recently received a vaccine, are scheduled to receive a vaccine, or are scheduled to have surgery
- if you have an infection, open cuts or sores on your body, flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection
- if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB
- if you live or have lived in certain parts of the country (eg, Ohio or Mississippi river valleys) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived in an area where these infections are common
- if you have recently received treatment with rituximab or another TNF blocker (eg, certolizumab, etanercept, infliximab)
Some MEDICINES MAY INTERACT with adalimumab. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Abatacept, anakinra, corticosteroids (eg, prednisone), methotrexate, rituximab, tocilizumab, another TNF blocker (eg, certolizumab, etanercept, infliximab), or other medicines that may weaken the immune system (eg, 6-mercaptopurine, azathioprine) because the risk of serious infection may be increased. Check with your doctor or pharmacist if you are unsure if any of your medicines may weaken the immune system
- Cyclosporine, theophylline, or warfarin because their effectiveness may be decreased by adalimumab
This may not be a complete list of all interactions that may occur. Ask your health care provider if adalimumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use adalimumab:
Use adalimumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Adalimumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get adalimumab refilled.
- Adalimumab is given as an injection under the skin. A health care provider will teach you how to use it. Adalimumab also comes with detailed instructions for use. Read them carefully. Be sure you understand how to use adalimumab. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use adalimumab if it contains particles, is cloudy or discolored, or if the syringe or pen is cracked or damaged.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
- Rotate injection sites. New injections should be given at least 1 inch from an old site. Do not inject into areas where the skin is tender, bruised, red, or hard, or where you have scars or stretch marks.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of adalimumab, use it as soon as you remember. Then go back to your regular dosing schedule. If you are not sure when to use adalimumab, check with your doctor or pharmacist.
Ask your health care provider any questions you may have about how to use adalimumab.
Important safety information:
- Adalimumab may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use adalimumab with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Adalimumab may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Before you use adalimumab, discuss your vaccination history with your doctor to be sure that you are up to date on vaccines.
- Adalimumab may increase the risk of developing blood cancer (eg, leukemia, lymphoma) or other types of cancer. This may be fatal in some cases. Discuss any questions or concerns with your doctor. Tell your doctor if you have ever had cancer. Contact your doctor right away if you develop any unusual symptoms, such as unusual bruising, unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, unexplained cough or shortness of breath, persistent unexplained itching, or unexplained weight loss.
- New or worsening nervous system problems (eg, MS, optic neuritis, Guillain-BarrÃ© syndrome, seizures) have occurred with TNF blockers. Tell your doctor if you have a condition that affects your nervous system. Discuss any questions or concerns with your doctor.
- Some patients who use adalimumab have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches).
- Severe liver problems have occurred with TNF blockers. Contact your doctor right away if you develop symptoms of liver problems (eg, dark urine; loss of appetite; pale stools, unusual stomach pain, tiredness, or vomiting; yellowing of the skin or eyes).
- Tell your doctor or dentist that you take adalimumab before you receive any medical or dental care, emergency care, or surgery.
- Adalimumab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking adalimumab. Talk with your doctor before you receive any vaccine.
- Adalimumab may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using adalimumab.
- Lab tests, including TB, liver function, and complete blood cell counts, may be performed while you use adalimumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use adalimumab with caution in the ELDERLY; they may be more sensitive to its effects, especially an increased risk of infection and certain types of cancer.
- Caution is advised when using adalimumab in CHILDREN; they may be at increased risk of developing certain types of cancer with adalimumab, which may be fatal.
- Adalimumab should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using adalimumab while you are pregnant. It is not known if adalimumab is found in breast milk. Do not breast-feed while using adalimumab.
Possible side effects of adalimumab:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; headache; mild pain, redness, or swelling at the injection site; mild stomach pain; nausea; runny or stuff nose.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry, or bloody stools; blood in the urine; burning, numbness, or tingling; butterfly-shaped rash on the nose and cheeks; change in the appearance of a mole; chest pain; confusion; fainting; fast or irregular heartbeat; mental or mood changes; muscle aches, pain, or weakness; new or worsening joint pain; new or worsening red, scaly patches or raised bumps filled with pus on the skin; open sore that does not heal; persistent pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; severe or persistent headache or dizziness; severe or persistent stomach pain; shortness of breath; signs of infection (eg, fever, chills, or persistent sore throat; persistent cough; blood in the phlegm; flu-like symptoms; warm, red, or painful skin or sores; diarrhea; increased or painful urination); swelling of the ankles, hands, or feet; tremor; unexplained weight loss or weight gain; unusual bruising or bleeding; unusual lumps; unusual skin growth or other skin changes; unusual tiredness or weakness; unusually pale skin; vision changes; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of adalimumab:
Store adalimumab in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Store in the original container until ready to use. If you need to take adalimumab with you, such as when traveling, store it in a cool carrier with an ice pack and protect it from light. Do not use after the expiration date on the dose tray label or prefilled syringe. Do not use adalimumab if it has ever been frozen. Keep adalimumab out of the reach of children and away from pets.
- If you have any questions about adalimumab, please talk with your doctor, pharmacist, or other health care provider.
- Adalimumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take adalimumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about adalimumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to adalimumab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using adalimumab.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.