This medicine is a monoclonal antibody used to treat certain forms of multiple sclerosis (MS) by slowing the worsening of physical disability and reducing the number of symptom flare-ups. This medicine is usually given to patients who cannot use other MS treatments or for whom other MS treatments have not worked well enough. This medicine is also used to treat moderate to severe Crohn disease in certain patients. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for using 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 usually administered as an injection at your doctor's office, hospital, or clinic. Do NOT shake the vial. STORE THIS MEDICINE as directed on the prescription label. DO NOT FREEZE. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor immediately.
WARNING: THIS MEDICINE INCREASES THE RISK OF A CERTAIN TYPE OF VIRAL BRAIN INFECTION called progressive multifocal leukoencephalopathy (PML). PML may cause severe disability or death. Your risk of PML may be greater if you currently take or have recently taken other medicines that may weaken your immune system, such as immunosuppressants (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or immunomodulators (eg, interferon beta). Your risk of developing PML may also increase if you have been exposed to JC virus or if you have used this medicine for a long time, especially over 2 years. TELL YOUR DOCTOR AT ONCE if you notice any new or worsening symptoms (eg, changes in thinking, eyesight, balance, memory, or strength; clumsiness; confusion; one-sided weakness; personality changes). This medicine is only available through a special program called the TOUCH Prescribing Program. Talk with your health care provider if you have questions about this program. 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 USE THIS MEDICINE if you have Crohn's disease and are also using an immunosuppressant (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or a tumor necrosis factor (TNF) inhibitor (eg, adalimumab). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are using immunomodulators (eg, interferon beta), medicine for cancer (eg, cisplatin), corticosteroids (eg, prednisone), TNF inhibitors (eg, adalimumab), or medicines that suppress your immune system (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate). Tell your doctor if you are receiving chemotherapy or radiation treatments. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor if you have a history of organ transplant or if you have any other medical conditions, including liver problems, fever, infection, immune system problems or a condition that may weaken the immune system (eg, HIV infection, leukemia, lymphoma), chronic or recurring infection, herpes, shingles, allergies, pregnancy, or breast-feeding. Tell your doctor if you have been tested and know whether or not you have anti-JC virus antibodies. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of progressive multifocal leukoencephalopathy (PML). Safety and effectiveness of this medicine in CHILDREN younger than 18 years old have not been confirmed. THIS MEDICINE IS NOT APPROVED FOR USE IN CHILDREN. 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 diarrhea, headache, indigestion, tiredness, joint pain, mild stomach discomfort, muscle cramps, or pain in the arms or legs. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience anxiety; chest pain or discomfort; depression; dizziness; fainting; fast heartbeat; feeling cold; fever, chills, cough, or persistent sore throat; flushing; muscle pain; nausea; one-sided weakness; painful menstrual periods; painful urination or changes in your amount of urine; severe or persistent headache or tiredness; severe or persistent stomach or back pain; shortness of breath or wheezing; suicidal thoughts or attempts; swelling of the hands, ankles, or legs; symptoms of liver problems (eg, dark urine; pale stools; right-sided stomach pain; unusual loss of appetite, nausea, vomiting, or weakness; yellowing of the skin or eyes); tremor; or vaginal discharge, itching, or odor. 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 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. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.