This medicine is a monoclonal antibody used to treat non-Hodgkin's lymphoma. It may be used alone or in combination with other medicines. It is used along with other medicines (fludarabine and cyclophosphamide) to treat a certain type of chronic lymphocytic leukemia (CLL). It is also used with another medicine (methotrexate) to treat moderate to severe rheumatoid arthritis in certain patients. It is also used along with corticosteroids (eg, methylprednisolone) to treat certain blood vessel disorders (Wegener granulomatosis / WG, microscopic polyangiitis / MPA). This medicine 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 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. YOU MAY RECEIVE OTHER MEDICINES before your dose of this medicine. This is to decrease the chance of an infusion reaction. Discuss any questions with your doctor. DO NOT USE THIS MEDICINE if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged in any way. STORE THIS MEDICINE as directed on the prescription label. KEEP THIS MEDICINE, as well as syringes and needles, out of reach of children and pets. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor immediately.
WARNING: Severe and sometimes fatal infusion reactions may occur with this medicine. These reactions may occur while you receive this medicine or within 24 hours after you receive it. Tell your doctor right away if you develop hives, itching, swelling, dizziness, blurred vision, drowsiness, headache, cough, wheezing, chest pain, fainting, irregular heartbeat, numbness of an arm or leg, or trouble breathing while you receive or after you receive this medicine. SEVERE AND SOMETIMES FATAL KIDNEY PROBLEMS AND SKIN REACTIONS MAY ALSO occur during treatment with this medicine. TELL YOUR DOCTOR RIGHT AWAY if you experience decreased urination; red, swollen, peeling, or blistered skin; or skin or mouth sores or ulcers. A RARE VIRAL INFECTION OF THE BRAIN (progressive multifocal leukoencephalopathy / PML) can occur with the use of this medicine in certain patients. PML is serious and sometimes fatal. Most cases of PML have occurred within 12 months of the last dose of this medicine. TELL YOUR DOCTOR RIGHT AWAY IF YOU NOTICE new or worsening medical problems, such as confusion, disorientation, or problems thinking; decreased strength or weakness; unusual vision problems (eg, blurred vision, loss of vision); trouble walking or talking; or loss of balance or coordination. 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 tocilizumab. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are using cisplatin or other chemotherapy, an immunosuppressant (eg, cyclosporine), or if you are taking medicines for high blood pressure. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Tell your doctor if you have rheumatoid arthritis and you are taking or have taken a tumor necrosis factor (TNF) inhibitor or a disease modifying anti-rheumatic drug (DMARD). Tell your doctor if you have had a recent vaccine or are scheduled to receive a vaccine. Inform your doctor of any other medical conditions, including a history of other cancer; frequent infections; infection that will not go away or keeps coming back; kidney problems; liver problems; hepatitis B, hepatitis C, or other viral infections (eg, cytomegalovirus, shingles, chickenpox, herpes, JC virus, parvovirus, West Nile); electrolyte problems; heart problems (eg, chest pain, irregular heartbeat); blood problems; autoimmune disorder (eg, lupus); bowel problems; lung or breathing problems; allergies; pregnancy; or breast-feeding. Tell your doctor if you have symptoms of infection (eg, fever, chills, persistent sore throat), if you have a weakened immune system, or if you are scheduled to have surgery. Tell your doctor if you have developed an infusion reaction, heart or lung problems, or serious skin problems from a previous dose of this medicine, or if you have taken this medicine for Wegener granulomatosis or microscopic polyangiitis in the past. USE OF THIS MEDICINE IS NOT RECOMMENDED if you currently have a severe infection. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are using this medicine to treat rheumatoid arthritis unless you have tried certain other medicines (tumor necrosis factor / TNF antagonists, such as infliximab) and they did not work well enough. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include diarrhea, mild fever and chills (especially with the first dose), flushing, indigestion, lightheadedness, mild muscle or joint pain, muscle spasms, nausea, night sweats, sneezing, throat irritation, trouble sleeping, vomiting, or weakness. If they continue or are bothersome, check with your doctor. A RARE VIRAL INFECTION OF THE BRAIN (PML) can occur with the use of this medicine in certain patients. PML is serious and sometimes fatal. Most cases of PML have occurred within 12 months of the last dose of this medicine. Signs of PML may include confusion, disorientation, or trouble thinking; decreased strength or weakness; unusual vision problems (eg, blurred vision, loss of vision); trouble walking or talking; or loss of balance or coordination. Tell your doctor right away if you notice any of these effects. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; dark urine; dark, tarry, or bloody stools; decreased amount or urine produced; dizziness; drowsiness; fainting; fast or irregular heartbeat; numbness of an arm or leg; persistent muscle, back, or joint pain; red, swollen, blistered or peeling skin; severe or persistent stomach pain; severe weakness or fatigue; shortness of breath; skin or mouth sores or ulcers; sudden leg pain; swelling of the hands, legs or feet; symptoms of infection (eg, cold symptoms, such as runny nose; cuts, scrapes, or surgery sites that are red, warm, swollen, or painful; earache; headache; fever, chills, cough, or persistent sore throat; flu-like symptoms, such as tiredness or body aches; painful urination; white patches in the mouth or throat); unusual bleeding or bruising; or wheezing. 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 throat; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. 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.