Brexucabtagene Autoleucel Injection
Brexucabtagene autoleucel injection may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). A doctor or nurse will monitor you carefully during your infusion and for at least 4 weeks afterwards. Tell your doctor if you have an inflammatory disorder or if you have or think you may have any type of infection now. You will be given medications 30 to 60 minutes before your infusion to help prevent reactions to brexucabtagene autoleucel. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills, fast or irregular heartbeat, muscle pain, shaking, diarrhea, tiredness, weakness, difficulty breathing, shortness of breath, cough, confusion, nausea, vomiting, dizziness, or lightheadedness.
Brexucabtagene autoleucel injection may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with brexucabtagene autoleucel. 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, dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, or difficulty speaking.
Brexucabtagene autoleucel injection is only available through a special restricted distribution program because of the risks of CRS and neurological toxicities. You can only receive the medication from a doctor and healthcare facility that participates in the program. Ask your doctor if you have any questions about this program.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body’s response to brexucabtagene autoleucel.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with brexucabtagene autoleucel 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.
🔔 Why is this medication prescribed?
Brexucabtagene autoleucel is used to treat mantle cell lymphoma (a fast-growing cancer that begins in the cells of the immune system) in adults that has returned or is unresponsive to other treatment(s). Brexucabtagene autoleucel is also used to treat certain acute lymphoblastic leukemia (ALL; also called acute lymphoblastic leukemia and acute lymphatic leukemia; a type of cancer that begins in the white blood cells) in adults that has returned or is unresponsive to other treatment(s). Brexucabtagene autoleucel injection is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient’s own blood. It works by causing the body’s immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells.
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🔔 How should this medicine be used?
Brexucabtagene autoleucel comes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a hospital or infusion center. It is usually given over a period of up to 30 minutes as a one-time dose. Before you receive your brexucabtagene autoleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for brexucabtagene autoleucel.
Before your dose of brexucabtagene autoleucel injection is to be given, a sample of your white blood cells will be taken at a cell collection center using a procedure called leukapheresis (a process that removes white blood cells from the body). Because this medication is made from your own cells, it must be given only to you. It is important to be on time and to not to miss your scheduled cell collection appointment(s) or to receive your treatment dose. If you are being treated for mantle cell lymphoma, your healthcare provider will check you daily for at least 7 days after you receive your brexucabtagene autoleucel dose to monitor you for any side effects. If you are being treated for ALL, your healthcare provider will check you daily for at least 14 days after you receive your brexucabtagene autoleucel dose to monitor you for any side effects. You should also plan to stay near where you received your brexucabtagene autoleucel treatment for at least 4 weeks after your dose. Your healthcare provider will check to see if your treatment is working and monitor you for any possible side effects. Talk to your doctor about how to prepare for leukapheresis and what to expect during and after the procedure.
