Special Alert:

The Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies such as brexucabtagene autoleucel injection.  At this time, benefits still outweigh the risks, but your doctor will monitor you during and after receiving treatment. Talk to your doctor about any concerns you have regarding your treatment.

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.

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.

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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving brexucabtagene autoleucel,

• tell your doctor and pharmacist if you are allergic to brexucabtagene autoleucel, any other medications, or any of the ingredients in brexucabtagene autoleucel. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have recently had an infection. Also tell your doctor if have or have ever had hepatitis B (HBV, a virus that infects the liver and may cause severe liver damage); seizures; a stroke; memory loss; lung or breathing problems; or kidney, heart, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You will need to have a pregnancy test before you start brexucabtagene autoleucel. If you become pregnant while receiving brexucabtagene autoleucel, call your doctor immediately.
• you should know that brexucabtagene autoleucel injection may make you drowsy and cause confusion, weakness, dizziness, seizures, and coordination problems. Do not drive a car or operate machinery for at least 8 weeks after your brexucabtagene autoleucel dose.
• do not donate blood, organs, tissues, or cells for transplantation after you receive your brexucabtagene autoleucel injection.
• check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting chemotherapy, during your brexucabtagene autoleucel treatment, and until your doctor tells you that your immune system has recovered.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss the appointment to collect your cells, you must call your doctor and the collection center right away. If you miss the appointment to receive your brexucabtagene autoleucel dose, you must call your doctor right away.

Brexucabtagene autoleucel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• stomach pain
• loss of appetite
• mouth pain
• difficulty swallowing
• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• pale skin or shortness of breath
• fever, sore throat, chills, or other signs of infection
• unusual bruising or bleeding
• decreased urination frequency or amount
• numbness, pain, tingling, or burning feeling in feet or hands

Brexucabtagene autoleucel injection may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication.

Brexucabtagene autoleucel injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor, the cell collection center, and the laboratory. Your doctor may order certain lab tests before, during, and after your treatment to check your body’s response to brexucabtagene autoleucel injection.

Ask your pharmacist any questions you have about brexucabtagene autoleucel.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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