Obecabtagene Autoleucel Injection

IMPORTANT WARNING:

Obecabtagene 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 14 days afterwards. Tell your doctor if you have an inflammatory disorder or if you have or think you may have any type of infection now. 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.

Obecabtagene autoleucel injection may cause severe, life-threatening, or fatal central nervous system reactions. These reactions can occur after treatment with obecabtagene 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 coordination or balance, or difficulty speaking.

Obecabtagene autotemcel injection may increase the risk that you will develop other cancers, including life-threatening blood cancers. Your doctor will monitor you after your treatment with obecabtagene autotemcel 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 will order certain tests before, during, and after your treatment to check your body's response to obecabtagene autoleucel injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with obecabtagene autoleucel injection 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 (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Obecabtagene autoleucel injection is used to treat 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). Obecabtagene 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Obecabtagene autoleucel comes as a suspension (liquid) to be slowly injected intravenously (into a vein) by a doctor or nurse in a hospital or infusion center. It is usually given as 2 doses, given about 10 days apart. Before you receive your first dose of obecabtagene autoleucel injection, your doctor or nurse will administer other chemotherapy medications to prepare your body for obecabtagene autoleucel.

Before your dose of obecabtagene 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 14 days after you receive your first obecabtagene autoleucel dose to monitor you for any side effects. You should also plan to stay near where you received your obecabtagene autoleucel treatment for at least 4 weeks after each 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.

Obecabtagene autoleucel injection may cause infusion reactions. Your doctor may give you medicines to prevent an infusion reaction at least 30 minutes before your receive obecabtagene autoleucel injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving obecabtagene autoleucel,

• tell your doctor and pharmacist if you are allergic to obecabtagene autoleucel, any other medications, human albumin, dimethyl sulfoxide (DMSO), or any of the ingredients in obecabtagene 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.

• tell your doctor if have or have ever had hepatitis B or C (HBV or HCV; viruses that infect the liver and may cause severe liver damage), 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 obecabtagene autoleucel. If you become pregnant while receiving obecabtagene autoleucel injection, call your doctor immediately.

• you should know that obecabtagene 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 last obecabtagene autoleucel dose.

• do not donate blood, organs, tissues, or cells for transplantation after you receive obecabtagene 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 obecabtagene autoleucel treatment, and until your doctor tells you that your immune system has recovered.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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

What SIDE EFFECTS can this medicine cause?

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

• diarrhea
• nausea
• vomiting
• stomach pain
• constipation
• weight loss
• decreased appetite
• headache
• mouth sores
• swelling of the arms, hands, legs, or feet
• muscle 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:

• rash; itching; hives; swelling of your face, mouth, tongue, or throat; chest pain; fast heartbeat; or difficulty swallowing or breathing
• fever, sore throat, chills, swollen glands, ongoing cough and congestion, or other signs of infection
• weakness, feeling tired, or shortness of breath
• unusual bleeding or bruising

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

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you have received obecabtagene 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.