Idecabtagene Vicleucel Injection

Idecabtagene vicleucel 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 idecabtagene vicleucel. 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.

Idecabtagene vicleucel injection may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with idecabtagene vicleucel. 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.

Idecabtagene vicleucel injection may cause a severe decrease in the number of certain types of blood cells in your blood. This may cause certain symptoms and may increase the risk that you will develop a serious infection or bleeding. If you experience any of the following symptoms after your treatment, tell your doctor immediately: fever, feeling tired, or have bruising or bleeding.

Idecabtagene vicleucel is only available through a special restricted distribution program. An Abecma REMS program (Risk Evaluation and Mitigation Strategy) has been set up because of the risks of CRS, central nervous system, and blood cell problems. 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 idecabtagene vicleucel 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.

Idecabtagene vicleucel injection is used to treat certain types of multiple myeloma (a type of cancer of the bone marrow) in adults whose cancer has returned or is unresponsive to at least four other treatments. Idecabtagene vicleucel 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.

Idecabtagene vicleucel injection 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 usually given over a total period of up to 30 minutes as a one-time dose. Before you receive your idecabtagene vicleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for idecabtagene vicleucel.

Before your dose of idecabtagene vicleucel 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. You should plan to stay within 2 hours of the location where you received your idecabtagene vicleucel 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 idecabtagene vicleucel injection,

• tell your doctor and pharmacist if you are allergic to idecabtagene vicleucel, any other medications, dimethyl sulfoxide (DMSO), or any of the ingredients in idecabtagene vicleucel injection. 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 while receiving idecabtagene vicleucel injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever had reactions from previous chemotherapy treatments such as breathing problems or irregular heartbeat. Also, tell your doctor if you have or have ever had lung, 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 idecabtagene vicleucel. If you become pregnant while receiving idecabtagene vicleucel, call your doctor immediately. Idecabtagene vicleucel may harm the fetus.
• you should know that idecabtagene vicleucel 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 idecabtagene vicleucel dose.
• do not donate blood, organs, tissues, or cells for transplantation after you receive your idecabtagene vicleucel 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 idecabtagene vicleucel treatment, and until your doctor tells you that your immune system has recovered.

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 idecabtagene vicleucel dose, you must call your doctor right away.

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

• constipation
• weight loss
• loss of appetite
• mouth pain
• dry mouth
• dry eyes

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:

• decreased urination frequency or amount
• swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
• difficulty swallowing
• rash
• hives
• itching

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

Idecabtagene vicleucel 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 idecabtagene vicleucel injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving idecabtagene vicleucel. This medication may affect the results of certain laboratory tests.

Ask your pharmacist any questions you have about idecabtagene vicleucel 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.

• Abecma^®