GENERIC NAME: ADALIMUMAB - INJECTION (A-da-LIM-ue-mab)
BRAND NAME(S): Humira
WARNING: This medication can decrease your immune system's ability to fight infections. Though unlikely, this drug may increase your risk of developing serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). This risk is higher if you are also taking other drugs to suppress the immune system such as cyclosporine. Tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for symptoms of infection, and seek immediate medical attention if symptoms occur.
Before starting this drug and during treatment, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, you must first be treated for it before you start adalimumab to prevent a serious TB infection.
Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen or painful abdomen, unexplained weight loss, persistent fever or night sweats.
USES: This medication is used to reduce pain and swelling due to certain types of arthritis (e.g., rheumatoid, psoriatic, and ankylosing spondylitis). This medication is also used to treat psoriasis (plaque-type). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage.Early treatment of rheumatoid arthritis with more aggressive therapy, including this type of medication (TNF blockers), helps to reduce further joint damage and preserve joint function.This medication is also used to treat certain bowel conditions (Crohn's disease, ulcerative colitis). It is used in cases that are moderate to severe and/or keep coming back.
HOW TO USE: Read the Patient Information Leaflet and the Medication Guide provided by your pharmacist before you start using adalimumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Use this medication exactly as prescribed. This drug is given under the skin (subcutaneously or SC) every other week, or weekly in some cases, or as directed by your doctor. Learn all preparation and usage instructions in the product package. Do not shake.Rotate injection sites. New injections should be given at least 1 inch (2.5 centimeter) from an old site. Do not inject into any areas of the skin that are sore, bruised, red or hard.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Learn how to store and discard needles and medical supplies safely. Never reuse syringes or needles. Consult your pharmacist.
SIDE EFFECTS: 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 have any serious side effects, including: fast/irregular/pounding heartbeat, stomach pain, blood in the stools, mental/mood changes, severe headache, easy bruising or bleeding, dark urine, yellowing eyes and skin, 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, extreme fatigue, joint pain, butterfly-shaped rash on the nose and cheeks.Get medical help right away if you have any very serious side effects, including: seizures, chest pain.Tell your doctor right away if you develop signs of infection while using this drug, such as: fever, chills, night sweats, persistent sore throat, trouble breathing, painful or frequent urination, persistent cough, unusual vaginal discharge, white patches in the mouth (oral thrush).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.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before using adalimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past/recurrent infections (such as hepatitis B, TB infection, histoplasmosis), decreased bone marrow function, seizures, certain brain/spinal cord/nerve disorders (demyelinating disorders such as multiple sclerosis, Guillain-Barre syndrome), history of cancer (e.g., lymphoma), a certain type of heart disease (heart failure), lupus.Adalimumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at greater risk for infections while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug passes into breast milk in small amounts. Consult your doctor before breast-feeding.
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DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: abatacept, live vaccines, other TNF-blockers (such as etanercept, infliximab), certain arthritis drugs (such as leflunomide, anakinra, tofacitinib), drugs that suppress the immune system (e.g., cyclosporine).
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., CBC, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
STORAGE: Store in the refrigerator away from light and moisture. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.