This medicine is an interleukin-6 (IL-6) receptor blocker used to treat moderate to severe rheumatoid arthritis in certain patients. It is also used to treat systemic juvenile idiopathic arthritis (SJIA) in children 2 years of age and older. It may be used alone or in combination with other medicine. It may also be used for other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. This medicine has 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 usually administered as an injection at your doctor's office, hospital, or clinic. DO NOT USE this medicine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. This medicine is usually handled and stored by a health care provider. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor.
WARNING: Patients who use this medicine have an increased risk of developing serious and sometimes fatal infections, including tuberculosis (TB), fungal infection, and other types of infection. Most patients who developed these infections were also taking medicine that suppressed their immune system (eg, corticosteroids, methotrexate). 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 weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin or sores; increased or painful urination; severe or persistent diarrhea; blood in the mucus). 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, golimumab, infliximab, rilonacept, rituximab, or tofacitinib. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking corticosteroids (eg, prednisone), methotrexate, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), cyclosporine, statins (eg, atorvastatin), oral contraceptives (birth control pills), theophylline, warfarin, or medicines that may harm the liver (eg, acetaminophen, ketoconazole, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the liver. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including low blood platelet or neutrophil levels; a history of hepatitis B infection or other liver problems; stomach or bowel problems (eg, diverticulitis, pain, bleeding, perforation, inflammation, ulcer); high cholesterol; high blood pressure; diabetes; kidney problems; cancer; numbness, tingling, or other nervous system problems (eg, multiple sclerosis, Guillain-Barre syndrome); 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); shingles; HIV; a weakened immune system; allergies; pregnancy; or breast-feeding. Tell your doctor if you have a history of an infection that keeps coming back; TB infection; or a positive TB skin test. Tell your doctor if you are using medicine to treat an infection; if you take medicine that may decrease your immune system (eg, cyclosporine); or if you have recently received or are scheduled to receive a vaccine. Tell your doctor if you have ever lived in or traveled to an area where TB is common; if you have come into close contact with a person with active TB; or if you have ever lived in or traveled to certain parts of the country (eg, Ohio or Mississippi river valleys, 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 in an area where these infections are common. Tell your doctor if you are using another medicine to treat rheumatoid arthritis, or if you will be having surgery or a medical procedure. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a severe infection (eg, sepsis) or any other active infection, or if you have liver problems. 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 dizziness or headache. If they continue or are bothersome, check with your doctor. SERIOUS AND SOMETIMES FATAL ALLERGIC REACTIONS have occurred in patients while receiving this medicine. These reactions may occur with any infusion of this medicine, even if it did not occur with a previous dose. Symptoms may include shortness of breath or trouble breathing; skin rash; swelling of the lips, tongue, or face; chest pain; dizziness; or fainting. Tell your doctor right away if you experience any of these symptoms or other unusual effects during or after an infusion. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bloody, dark, or tarry stools; burning, numbness, or tingling; chest pain; fainting; muscle weakness or aches; pain in the hands or feet; persistent pain, swelling, or redness at the injection site; 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; increased or painful urination; severe or persistent diarrhea; unexplained weight loss; blood in mucus); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; nausea; loss of appetite); unusual bruising or bleeding; unusual skin growth or other skin changes; unusual tiredness or weakness; vision changes; or vomit that contains blood or 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.
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. 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.