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Axicabtagene ciloleucel is an immunotherapy medicine used to treat large B-cell lymphoma in adults. This medicine is given after at least two other treatments have failed.

Axicabtagene ciloleucel is made from your own white blood cells, removed from a small amount of blood drawn from your body.

Axicabtagene ciloleucel is available under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Axicabtagene ciloleucel may also be used for purposes not listed in this medication guide.

A serious side effect of this medicine is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.

Axicabtagene ciloleucel can also cause life-threatening nerve problems. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, or a seizure.

To make sure axicabtagene ciloleucel is safe for you, tell your doctor if you have ever had:

• an active or chronic infection;

• memory problems;

• a seizure;

• liver or kidney disease;

• a stroke; or

• if you have received a vaccine in the past 2 weeks.

Women may need pregnancy testing before receiving this medicine. You may also need to use birth control to prevent pregnancy during and shortly after treatment with axicabtagene ciloleucel and chemotherapy.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you receive axicabtagene ciloleucel during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.

It is not known whether axicabtagene ciloleucel passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Call your doctor for instructions if you miss any of your chemotherapy treatment, or if you miss a dose of your medications to prevent side effects of axicabtagene ciloleucel.

Other drugs may interact with axicabtagene ciloleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Administration Advice:
-This drug is for autologous and intravenous use only.
-Use central venous access for drug infusion.
-Infuse this drug by either gravity or a peristaltic pump; do not use a leukodepleting filter.
-Before infusing this drug, thaw it at approximately 37 degrees Celsius using either a water bath or dry thaw method until there is no visible ice in the infusion bag.
-Ensure tocilizumab and emergency equipment are available prior to drug infusion and during the recovery period.
-Administer this drug at a certified healthcare facility.
-Refer to the administration instructions in the manufacturer product information before infusing this drug.

Storage Requirements:
-Store this drug frozen in the vapor phase of liquid nitrogen (minus 150 degrees Celsius or less); thaw before using.
-Once thawed, this drug may be stored at room temperature (20 to 25 degrees Celsius) for up to 3 hours.

Reconstitution/Preparation Techniques:
-Consult the manufacturer product information for instructions on preparing this drug for IV infusion.

General:
-Each single infusion bag of this drug contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL.
-In addition to T cells, this drug contains 5% dimethylsulfoxide (DMSO) and 2.5% albumin (human); it may contain NK and NK-T cells as well.
-Follow universal precautions and local biosafety guidelines for handling and disposal of this drug to avoid potential transmission of infectious diseases.

Monitoring:
-Hematologic: Blood counts (after drug infusion)
-Immunologic: Signs/symptoms of cytokine release syndrome (at least daily for 7 days following drug infusion, then for 4 weeks after infusion); immunoglobulin levels (after drug treatment)
-Infections/Infestations: Signs/symptoms of infection (before and after drug infusion); screening for HBV, HCV, and HIV (before collection of cells for manufacturing)
-Nervous System: Signs/symptoms of neurologic toxicities (at least daily for 7 days following drug infusion, then for 4 weeks after infusion)
-Oncologic: Secondary malignancies (life-long)

Patient Advice:
-For at least 4 weeks after you receive an infusion of this drug, stay close to the certified healthcare facility where the drug was given to you.
-Avoid potentially dangerous activities such as driving and operating machinery for at least 8 weeks after receiving an infusion of this drug.