IMPORTANT WARNING:
Elranatamab-bcmm injection may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). Tell your doctor if you have an inflammatory disorder or if you have or think you may have any type of infection now. Your doctor may tell you to take certain medications before receiving elranatamab-bcmm injection to prevent this reaction. If you experience any of the following symptoms during and after your injection, tell your doctor immediately: fever, chills, fast or irregular heartbeat, difficulty breathing, shortness of breath, cough, confusion, anxiety, restlessness, headache, dizziness, lightheadedness, muscle pain, shaking, diarrhea, nausea, vomiting, tiredness, or weakness.
Elranatamab-bcmm injection may cause severe or life-threatening central nervous system reactions called immune effector cell-associated neurotoxicity syndrome (ICANS). Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: headache; restlessness; confusion; loss of consciousness; seizures; uncontrollable shaking or jerking of a part of the body; hearing loss; double vision; difficulty speaking or writing; difficulty walking; muscle tightening or spasms; muscle weakness; burning, throbbing, or stabbing pain; or numbness and tingling of the skin.
You may experience CRS or central nervous system reactions while you receive a dose of elranatamab-bcmm injection, but these reactions may occur afterwards. These reactions are more common with the first 3 doses of elranatamab-bcmm injection but may occur at any time during treatment. A doctor or nurse will monitor you carefully in a hospital or medical facility during your injections and for 48 hours after at least your first 3 doses of elranatamab-bcmm injection to be sure you are not having a serious reaction to the medication.
Because of the risks of CRS and ICANS, elranatamab-bcmm is only available through a restricted program called the ELREXFIO REMS. Your doctor will register you in the program. elranatamab-bcmm is only available at certain pharmacies that are registered with ELREXFIO REMS. Ask your doctor or pharmacist if you have any questions about how you can fill your prescription.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to elranatamab-bcmm injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with elranatamab-bcmm injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm ) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risk(s) of receiving elranatamab-bcmm injection.