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Drug Information For:
HUMIRA SYR 40MG/0.8ML 2TRAYS
Ingredient Name:ADALIMUMAB (a-da-LIM-ue-mab)
Common Uses:This medicine is a tumor necrosis factor (TNF) blocker 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.
Before Using This Medicine:WARNING: Patients who use this medicine 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 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 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). THIS MEDICINE IS A 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 this medicine. 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 HSTCL were usually using this medicine along with azathioprine or 6-mercaptopurine. 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, anakinra, or another TNF-blocker (eg, etanercept). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking cyclosporine, theophylline, warfarin, medicine to treat an infection, or medicine that may weaken the immune system (eg, 6-mercaptopurine; azathioprine; corticosteroids, such as prednisone; methotrexate; rituximab; tocilizumab). Check with your doctor or pharmacist if you are unsure if any of your medicines may weaken the immune system. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of an infection that keeps coming back; TB infection or positive TB skin test; liver problems (eg, hepatitis B); heart problems (eg, heart failure); high cholesterol; high blood pressure; diabetes; cancer (eg, lymphoma); blood problems; bone marrow problems; an autoimmune disorder (eg, lupus) or other immune system problems (eg, weakened immune system); numbness, tingling, or other nervoussystem problems (eg, multiple sclerosis / MS, optic neuritis, Guillain-Barre syndrome); allergies (eg, rubber, latex); pregnancy; or breast-feeding. Tell your doctor if you have recently received a vaccine, are scheduled to receive a vaccine, are scheduled to have surgery, or have recently received treatment with rituximab or another TNF blocker. Tell your doctor if you have an infection, open cuts or sores on your body, or flu-like symptoms or other signs of infection (eg, fever; chills; sweats; cough; warm, red, or painful skin). 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 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. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use 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. It also comes with an additional patient leaflet with detailed instructions for use. Read them 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. DO NOT RECEIVE A LIVE VACCINE (eg, measles, mumps) or treatment with a weakned bacteria (eg, BCG for bladder cancer) while you are taking this medicine. Talk with your doctor before you receive any vaccine. Before you use this medicine, discuss your vaccination history with your doctor to be sure that you are up to date on vaccines. 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. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and pets. IF YOU MISS A DOSE of this medicine, use it as soon as you remember. Then go back to your regular dosing schedule. If you are not sure when to take this medicine, check with your doctor or pharmacist.
Cautions:DO NOT USE THIS MEDICINE if you are allergic to any ingredient in this medicine. LAB TESTS 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 INTERFERE WITH CERTAIN LAB TESTS. Be sure your doctor and lab personnel know you are using this medicine. 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. THIS MEDICINE 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, multiple sclerosis, optic neuritis, Guillain-Barre syndrome) 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 THIS MEDICINE 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). 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. Tell your doctor if you have unusual bruising or bleeding; or dark, tarry, or bloody stools. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY AND CHILDREN because they may be more sensitive to the effects of the medicine. FOR WOMEN: IF YOU BECOME PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. If you used this medicine during pregnancy, tell your baby's doctor. IT IS NOT KNOWN IF THIS MEDICINE IS FOUND in breast milk. DO NOT BREAST-FEED while taking this medicine.
Possible Side Effects:SIDE EFFECTS that may occur while taking this medicine include back pain; headache; mild pain, redness, or swelling at the injection site; mild stomach pain; nausea; or runny or stuffy nose. If they continue or are bothersome, check with your doctor. 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). CONTACT YOUR DOCTOR IMMEDIATELY if you experience blood in the urine; black, tarry, or bloody stools; 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; 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 growths or other skin changes; unusual tiredness or weakness; unusually pale skin; vision changes; or vomit that looks like coffee grounds. 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.
Overdose:If overdose is suspected, contact your local poison control center or emergency room immediately.
Additional Information:DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2014 Wolters Kluwer Health, Inc.