Special Alert:

Lisocabtagene maraleucel 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 lisocabtagene maraleucel. 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.

Lisocabtagene maraleucel injection may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with lisocabtagene maraleucel. 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 or slurred speach.

Lisocabtagene maraleucel injection may increase your risk of developing certain cancers, including certain types of blood cancers. Your doctor will monitor you carefully after your treatment with lisocabtagene maraleucel. Talk to your doctor about the risks of receiving this medication.

Lisocabtagene maraleucel injection is only available through a special restricted distribution program. A Breyanzi REMS program (Risk Evaluation and Mitigation Strategy) has been set up 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.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with lisocabtagene maraleucel 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.

Lisocabtagene maraleucel is used to treat certain types of large B-cell lymphoma (a type of cancer that begins in the white blood cells) in certain adults whose cancer has returned or is unresponsive to other treatments. Lisocabtagene maraleucel is also used to treat chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) or small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes) that has returned or is unresponsive to at least two other treatments. Lisocabtagene maraleucel 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.

Lisocabtagene maraleucelcomes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a doctor’s office or infusion center. It is usually given as two infusions over a total period of up to 30 minutes as a one-time dose. Before you receive your lisocabtagene maraleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for lisocabtagene maraleucel.

Before your dose of lisocabtagene maraleucel 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. Your healthcare provider will check you daily for at least 10 days after you receive your lisocabtagene maraleucel dose to monitor you for any side effects. You should also plan to stay near where you received your lisocabtagene maraleucel 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 lisocabtagene maraleucel,

• tell your doctor and pharmacist if you are allergic to lisocabtagene maraleucel, any other medications, dimethyl sulfoxide (DMSO), or any of the ingredients in lisocabtagene maraleucel. 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 ever had hepatitis B virus; lung or breathing problems; or heart, kidney, or liver problems.
• 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 lisocabtagene maraleucel. If you become pregnant while receiving lisocabtagene maraleucel, call your doctor immediately.
• you should know that lisocabtagene maraleucel 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 lisocabtagene maraleucel dose.
• do not donate blood, organs, tissues, or cells for transplantation after you receive your lisocabtagene maraleucel 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 lisocabtagene maraleucel 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 lisocabtagene maraleucel dose, you must call your doctor right away.

Lisocabtagene maraleucel 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
• swelling of your hands, legs, feet, or ankles
• numbness, pain, tingling, or burning feeling in feet or hands
• back, neck, leg, arm, or joint pain

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 or get emergency medical treatment:

• feeling tired
• bruising or bleeding
• fever, sore throat, chills, or other signs of infection
• confusion
• fast or irregular heartbeat
• rash; itching; hives; swelling of your face, mouth, tongue, or throat; chest pain; fast heartbeat; or difficulty swallowing or breathing

Lisocabtagene maraleucel 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 lisocabtagene maraleucel injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving lisocabtagene maraleucel.

Ask your pharmacist any questions you have about lisocabtagene maraleucel.

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.

• Breyanzi^®