Special Alert:

The Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies such as ciltacabtagene autoleucel injection.  At this time, benefits still outweigh the risks, but your doctor will monitor you during and after receiving treatment. Talk to your doctor about any concerns you have regarding your treatment.

Ciltacabtagene 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 10 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. You will be given medications 30 to 60 minutes before your infusion to help prevent reactions to ciltacabtagene autoleucel. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills, headache, fast or irregular heartbeat, muscle pain, shaking, diarrhea, tiredness, weakness, difficulty breathing, shortness of breath, cough, confusion, nausea, vomiting, dizziness, or lightheadedness.

Ciltacabtagene autoleucel injection may cause severe, life-threatening, or fatal central nervous system reactions. These reactions can occur days, weeks or months after treatment with ciltacabtagene 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: dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, difficulty with handwriting, agitation, seizures, slow moving, change in personality or loss in interest in usual activities, loss of coordination or balance, weakness, difficulty speaking, or numbness in the face.

Ciltacabtagene autoleucel 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. Tell your doctor if you have or recently had an infection. If you experience any of the following symptoms after your treatment, tell your doctor immediately: fever, chills, or other signs of infection; feeling tired; or have bruising or bleeding.

Ciltacabtagene autoleucel injection is only available through a special restricted distribution program. A Carvykti REMS program (Risk Evaluation and Mitigation Strategy) has been set up because of the risks of CRS and 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 ciltacabtagene autoleucel 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.

Ciltacabtagene autoleucel is used to treat multiple myeloma (a type of cancer of the bone marrow) in adults that has returned or that did not respond to at least 4 other treatments. Ciltacabtagene 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.

Ciltacabtagene autoleucel comes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a hospital or infusion center. It is usually given over 30 to 60 minutes as a one-time dose. Before you receive your ciltacabtagene autoleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for ciltacabtagene autoleucel.

Before your dose of ciltacabtagene 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 10 days after you receive your ciltacabtagene autoleucel dose to monitor you for any side effects. You should also plan to stay near where you received your ciltacabtagene 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.

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

Before receiving ciltacabtagene autoleucel,

• tell your doctor and pharmacist if you are allergic to ciltacabtagene autoleucel, any other medications, dimethyl sulfoxide (DMSO), or any of the ingredients in ciltacabtagene 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 have or have ever had 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 ciltacabtagene autoleucel. You or your partner should not become pregnant while you are receiving ciltacabtagene autoleucel. If you become pregnant while receiving ciltacabtagene autoleucel, call your doctor immediately. Ciltacabtagene autoleucel may harm the fetus.
• you should know that ciltacabtagene 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 ciltacabtagene autoleucel dose.
• do not donate blood, organs, tissues, or cells for transplantation after you receive your ciltacabtagene 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 ciltacabtagene autoleucel 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 ciltacabtagene autoleucel dose, you must call your doctor right away.

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

• diarrhea
• loss of appetite
• joint, muscle, or bone pain
• swelling
• constipation

Some side effects can be serious. If you experience any of these symptoms or those symptoms listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

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

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

Ciltacabtagene 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 (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 ciltacabtagene 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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