Afamitresgene Autoleucel Injection

Afamitresgene autoleucel may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). A doctor or nurse will monitor you carefully during your infusion, during your stay at the healthcare facility (at least 7 days), and for at least 4 weeks after your treatment. You will be given medications 30 to 60 minutes before your infusion to help prevent reactions to afamitresgene autoleucel. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills/shivering, difficulty breathing, fast or irregular heartbeat, dizziness or lightheadedness, tiredness, nausea, vomiting, or diarrhea, headache, or rash.

Afamitresgene autoleucel is only available through a special restricted distribution program because of the risks of CRS. 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 afamitresgene autoleucel. 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 (https://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 afamitresgene autoleucel.

Afamitresgene autoleucel is used in adults to treat certain types of synovial sarcoma that cannot be treated with surgery or is unresponsive to other treatments. Afamitresgene autoleucel 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.

Afamitresgene autoleucel comes as a suspension (liquid) to be given intravenously (into a vein) by a doctor or nurse in a hospital. It is usually given in an hour or less as a one-time dose. Before you receive your afamitresgene autoleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for afamitresgene autoleucel.

Before your dose of afamitresgene 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. Your healthcare provider will check you daily for at least 7 days after you receive your afamitresgene autoleucel dose to monitor you for any side effects. You should also plan to stay near where you received your afamitresgene 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.

Afamitresgene autoleucel is also sometimes used to treat other conditions. Talk to your doctor about the risks of using this medication for your condition.

Before taking afamitresgene autoleucel,

• tell your doctor and pharmacist if you are allergic to afamitresgene autoleucel, any other medications, dimethyl sulfoxide (DMSO), or any of the ingredients in afamitresgene autoleucel injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what 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 seizure, stroke, confusion, or memory loss; low blood pressure; a current infection; hepatitis B or C (HBV or HCV; viruses that infect the liver and may cause severe liver damage) or other viruses such as cytomegalovirus (a common virus that usually only causes serious symptoms in people who have weakened immune systems or who are infected at birth) or human immunodeficiency virus (HIV); 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 afamitresgene autoleucel. You should not become pregnant while you are receiving afamitresgene autoleucel treatment. If you become pregnant while receiving afamitresgene autoleucel, call your doctor immediately.
• you should know that afamitresgene 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 4 weeks after your afamitresgene autoleucel dose.
• do not donate blood, organs, tissues, or cells for transplantation after you receive your afamitresgene autoleucel injection.

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 afamitresgene autoleucel dose, you must call your doctor right away.

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

• nausea, diarrhea, or vomiting
• constipation
• stomach pain
• loss of appetite
• back pain
• swelling

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:

• pale skin or shortness of breath
• fever, sore throat, chills, or other signs of infection
• unusual bruising or bleeding
• disorientation to time and place, drowsiness, trouble paying attention, seizures, trouble thinking or speaking, or weakness

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

Afamitresgene autoleucel 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).

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 afamitresgene autoleucel injection.

Ask your pharmacist any questions you have about afamitresgene autoleucel injection.

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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