Axicabtagene Ciloleucel Injection

Axicabtagene ciloleucel 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 60 minutes before your infusion to help prevent reactions to axicabtagene ciloleucel. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills, fast or irregular heartbeat, shaking, diarrhea, tiredness, weakness, difficulty breathing, shortness of breath, confusion, nausea, vomiting, dizziness, or lightheadedness.

Axicabtagene ciloleucel injection may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with axicabtagene ciloleucel. 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, difficulty understanding, or difficulty speaking.

Axicabtagene ciloleucel injection is only available through a special restricted distribution program because of the risks of CRS and neurological toxicities. 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 axicabtagene ciloleucel. 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.

🔔 Why is this medication prescribed?

Axicabtagene ciloleucel injection is used to treat a certain type of non-Hodgkin’s lymphoma (cancer that begins in white blood cells that normally fight infection) that has returned or is unresponsive to other treatment(s) in people who have already been treated with at least two other chemotherapy medications. Axicabtagene ciloleucel 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.

🔔 How should this medicine be used?

Axicabtagene ciloleucel 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 period of up to 30 minutes as a one-time dose. Before you receive your axicabtagene ciloleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for axicabtagene ciloleucel.

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Before your dose of axicabtagene ciloleucel 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 near where you received your axicabtagene ciloleucel 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.

🔔 Other uses for this medicine

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

🔔 What special precautions should I follow?

Before receiving axicabtagene ciloleucel injection,

• tell your doctor and pharmacist if you are allergic to axicabtagene ciloleucel, gentamicin, any other medications, dimethyl sulfoxide (DMSO), or any other ingredients in axicabtagene ciloleucel 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. Be sure to mention any of the following: steroids such as dexamethasone, methylprednisolone (Medrol), prednisolone, and prednisone (Rayos). 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 breathing problems or lung, kidney, heart, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to have a pregnancy test before you start axicabtagene ciloleucel treatment. If you become pregnant while receiving axicabtagene ciloleucel injection, call your doctor immediately.
• you should know that axicabtagene ciloleucel 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 axicabtagene ciloleucel dose.
• do not donate blood, organs, tissues, or cells for transplantation after you receive your axicabtagene ciloleucel 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 axicabtagene ciloleucel 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.