This medicine is a tumor necrosis factor (TNF) blocker used to treat rheumatoid arthritis in certain patients along with methotrexate. It is also used to treat psoriatic arthritis alone or with methotrexate . It may also be used to treat ankylosing spondylitis or other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor.AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. In the United States, the patient leaflet is a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. 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. IF YOU ARE USING THIS MEDICINE AT HOME, a healthcare professional will provide detailed instructions for appropriate use. Ask them any questions that you may have about your medicine or giving injections. THIS MEDICINE SHOULD BE COLORLESS TO SLIGHTLY YELLOW IN APPEARANCE. If the medicine contains particles, is cloudy or discolored, or if the syringe or autoinjector is cracked or damaged in any way, do not use it. DO NOT SHAKE this medicine before use. ALLOW THE PREFILLED SYRINGE OR AUTOINJECTOR TO SIT OUT AT ROOM TEMPERATURE FOR 30 MINUTES before using. Do not warm this medicine in any other way. Do not remove the needle cover or the cap on the autoinjector until right before use. 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, scaly, 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), in the original container until ready to use. Do not freeze. Protect from light. 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 prefilled syringe or autoinjector. Do not use this medicine if it has ever been frozen or heated. 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.
WARNING: Serious and sometimes fatal infections, including tuberculosis (TB), fungal infection, and other types of infection, have occurred in patients using this medicine. Most patients who developed these infections were taking medicines that suppressed their immune system (eg, methotrexate, corticosteroids). 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 symptoms of TB or any other infection (eg, persistent cough or sore throat, muscle weakness, weight loss, fever, chills, unusual vaginal discharge, painful or frequent urination, persistent feeling of being unwell). This medicine 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. 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 also taking abatacept, adalimumab, anakinra, canakinumab, certolizumab, etanercept, infliximab, rilonacept, rituximab, tocilizumab, or tofacitinib. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), cyclosporine or any other medicine that may decrease your immune system, or theophylline. Tell your doctor if you have recently received rituximab. 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, including allergies to rubber or latex; pregnancy; or breast-feeding. Tell your doctor if you have a history of infections or an infection that keeps coming back; TB infection or positive TB skin test; hepatitis B infection or other liver problems; heart problems (eg, heart failure); low blood platelets, white blood cells, or hemoglobin; asthma; diabetes; HIV; lymphoma or another type of cancer; or numbness, tingling, or other nervous system problems (eg, multiple sclerosis, Guillain-Barre syndrome). Tell your doctor if you 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 are using medicine to treat an infection. Tell your doctor 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; or if you live, have lived, or traveled to certain parts of the country (eg, Ohio or Mississippi river valleys and the Southwest) 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 or traveled in an area where these infections are common. Tell your doctor if you have recently received a vaccine, are scheduled to receive a vaccine, or are scheduled to have surgery. 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 taking this medicine.
SIDE EFFECTS that may occur while using this medicine include cold sores; hoarseness; mild itching, pain, redness, or swelling at the injection site; mild sore throat; or runny or stuffy nose. If they continue or are bothersome, check 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). A RARE TYPE OF CANCER called HSTCL has been reported in patients using TNF blockers. These cases have been fatal. Most of these cases occurred in teenagers or young adults. Most of these patients had Crohn disease or ulcerative colitis. Patients who developed this cancer were usually using this medicine along with certain other medicines (azathioprine, 6-mercaptopurine). Tell your doctor if you have or have ever had any type of cancer. Tell your doctor right away if you develop stomach pain or tenderness, fever, night sweats, or unexplained weight loss. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blood in the urine or stools; butterfly-shaped rash on the nose or cheeks; chest pain; diarrhea; eye pain; fainting; fast or irregular heartbeat; increased sensitivity to the sun; mental or mood changes; muscle pain or weakness; new or worsening joint pain; new or worsening red, scaly patches or raised bumps that fill with pus on the skin; numbness, burning, or tingling; open sore that does not heal; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or dizziness; severe or persistent stomach pain; severe or persistent pain, swelling, bruising, itching, or redness at the injection site; shortness of breath; signs of infection (eg, fever, chills, or persistent cough or sore throat; flu-like symptoms; muscle aches; warm, red, or painful skin or sores; increased or painful urination; blood in the mucus; tooth pain); swelling of the ankles, hands, or feet; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, unusual nausea, loss of appetite); unusual bruising or bleeding; unusual lumps; unusual tiredness or weakness; unusually pale skin; vision changes (including vision loss); vomiting; or weakness in the arms or legs. 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; or swelling of the mouth, face, lips, or tongue. 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. You may report side effects to FDA at 1-800-FDA-1088.
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. 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. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.