Lisocabtagene Maraleucel Injection

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 2 weeks after. Tell your doctor if you have an inflammatory disorder or if you have or recently have had any type of infection. You will be given medications 30 to 60 minutes before your infusion to help prevent reactions. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills, shaking, fast or irregular heartbeat, muscle pain, diarrhea, tiredness, weakness, difficulty breathing, shortness of breath, cough, confusion, nausea, vomiting, dizziness, or lightheadedness.

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

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 injection. Talk to your doctor about the risks of receiving this medication.

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.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Talk to your doctor about the risks of receiving lisocabtagene maraleucel injection.

Lisocabtagene maraleucel injection is used to treat certain types of lymphoma (cancer that begins in the cells of the immune system) and chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells). 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 maraleucel comes 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 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 give you other chemotherapy medications to prepare your body for lisocabtagene maraleucel.

Lisocabtagene maraleucel is made from your own cells and must be given only to you.Before you receive lisocabtagene maraleucel injection, a sample of your white blood cells will be taken at a treatment center using a procedure called leukapheresis (a process that removes white blood cells from the body). The sample will be sent to the manufacturer to prepare a dose of lisocabtagene maraleucel injection. It will take about 3 to 4 weeks from the time that your blood cells are collected before they are ready to be given to you.

It is important to be on time and to not miss your scheduled cell collection appointment(s) or to receive your treatment dose. Your healthcare provider will check you daily for at least 7 days after you receive your lisocabtagene maraleucel dose to monitor you for any side effects. You should plan to stay near where you received your treatment for at least 2 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 or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• 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 receive lisocabtagene maraleucel injection. If you become pregnant while receiving lisocabtagene maraleucel injection, 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 2 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, call your doctor and the collection center right away. If you miss the appointment to receive your lisocabtagene maraleucel dose, call your doctor right away.

Lisocabtagene maraleucel injection 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
• rash; itching; hives; swelling of your face, mouth, tongue, or throat; chest pain; fast heartbeat; or difficulty swallowing or breathing

Lisocabtagene maraleucel 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

Ask your pharmacist any questions you have about lisocabtagene maraleucel injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Breyanzi^®