Axicabtagene Ciloleucel Injection

IMPORTANT WARNING:

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.

IMPORTANT NOTICE:

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 axicabtagene ciloleucel 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.

WHY is this medicine 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.

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?

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.

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.

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 prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using axicabtagene ciloleucel 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 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.

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 axicabtagene ciloleucel dose, you must call your doctor right away.

What SIDE EFFECTS can this medicine cause?

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

• constipation
• stomach pain
• back pain
• joint or muscle pain
• dry mouth
• loss of appetite
• weight loss

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:

• blood in urine
• bleeding more easily than normal
• fever, sore throat, chills, or other signs of infection
• decreased urination frequency or amount
• pale skin
• fatigue
• swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
• difficulty swallowing
• rash
• hives
• itching

Axicabtagene ciloleucel injection may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication.

Axicabtagene ciloleucel 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).

What OTHER INFORMATION should I know?

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 axicabtagene ciloleucel injection.

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

Ask your pharmacist any questions you have about axicabtagene ciloleucel 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.