Learn more about usage, cautions, and possible side effects .
Chemical Name: ADALIMUMAB (a-da-LIM-ue-mab)
This medicine is a tumor necrosis factor (TNF) blocker used for treating a variety of moderate to severe inflammatory conditions (eg, rheumatoid arthritis, juvenile rheumatoid arthritis [JRA], psoriatic arthritis, ankylosing spondylitis). It is also used to treat certain patients with moderate to severe Crohn disease and certain patients with 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.
WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS including tuberculosis, fungal infection, and other types of infection have occurred in patients using this medicine. Most patients who developed these infections were also taking medicine that suppressed their immune system (eg, corticosteroids, methotrexate). PATIENTS SHOULD RECEIVE A TUBERCULOSIS (TB) SKIN TEST before using this medicine. Patients who test positive for TB should begin treatment for TB before starting this medicine. All patients should also be monitored for signs of TB while using this medicine 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 weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin; increased or painful urination). Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE IF you are using abatacept or anakinra, or if you will be receiving a live vaccine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking corticosteroids (eg, prednisone) or methotrexate. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including an autoimmune disorder (eg, lupus) or other immune system problems; allergies; pregnancy; or breast-feeding. Tell your doctor if you have a history of an infection that keeps coming back; TB infection or positive TB skin test; hepatitis B infection; heart problems (eg, heart failure); high cholesterol; high blood pressure; cancer; or numbness, tingling, or other nervous system problems (eg, multiple sclerosis, Guillain-Barre syndrome). Tell your doctor if you have recently received a vaccine, are scheduled to receive a vaccine, or if you are scheduled to have surgery. Tell your doctor if you currently have 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 if you are currently using medicine to treat an infection or that may decrease your immune system. Tell your doctor if you have ever lived in or traveled to an area where TB is common; have come into close contact with a person with active TB; or 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. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a severe infection (eg, sepsis) or any other active infection. This medicine should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
Follow the directions for taking this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE IS GIVEN AS AN INJECTION under the skin. A health care provider will teach you how to use it. Be sure you understand how to use this medicine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. DO NOT USE THIS MEDICINE 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. STORE THIS MEDICINE 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 this medicine 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 this medicine if it has ever been frozen. IF YOU MISS A DOSE of this medicine, use it as soon as you remember. Then go back to your regular dosing schedule.
DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine, rubber, or latex. LAB TESTS, including TB tests, liver function, and complete blood counts, may be performed while you use this medicine. These tests may be used to monitor your condition or check for side effects. KEEP ALL DOCTOR AND LAB APPOINTMENTS. THIS MEDICINE MAY CAUSE DIZZINESS OR VISION CHANGES. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine 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. THIS MEDICINE 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. TNF BLOCKERS MAY INCREASE THE RISK OF developing certain types of cancer. Patients with rheumatoid arthritis who use this medicine, especially those with more severe rheumatoid arthritis, have an increased risk of developing lymphoma. Talk with your doctor if you have questions about your risk of developing any type of cancer while using this medicine. TELL YOUR DOCTOR OR DENTIST THAT YOU TAKE THIS MEDICINE before you receive any medical or dental care, emergency care, or surgery. THIS MEDICINE 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 this medicine. Talk with your doctor before you receive any vaccine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. USE THIS MEDICINE WITH CAUTION IN THE ELDERLY; they may be more sensitive to its side effects, especially an increased risk of infection and certain types of cancer. FOR WOMEN: IF YOU BECOME PREGNANT, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. IT IS NOT KNOWN IF THIS MEDICINE IS FOUND in breast milk. DO NOT BREAST-FEED while taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include back pain; headache; mild pain, redness, or swelling at the injection site; nausea; sinus inflammation; or stomach pain. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blood in the urine or stools; butterfly-shaped rash on the nose and cheeks; chest pain; fainting; fast or irregular heartbeat; mental or mood changes; muscle pain or weakness; new or worsening joint pain; numbness, tingling, or pain in the hands or feet; open sore that does not heal; persistent cough; persistent pain, swelling, or redness at the injection site; red, swollen, or blistered 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; warm, red, or painful skin; increased or painful urination); swelling of the ankles, hands, or feet; unexplained weight loss; unusual bruising or bleeding; unusual lumps; unusual tiredness or weakness; unusually pale skin; or vision changes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
If overdose is suspected, contact your local poison control center or emergency room immediately.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and 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.
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