Axicabtagene Ciloleucel suspension for injection

What is this medicine?

AXICABTAGINE CILOLEUCEL (ax i kab ta jeen sye loe loo sel) is a gene therapy that is made from cells in your immune system. It is used to treat large B-cell lymphoma.

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting. This medicine is made from your own immune cells.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• fast, irregular heartbeat

• severe nausea, vomiting, or diarrhea

• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• trouble speaking or understanding

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation

• decreased appetite

• headache

• stomach pain

• tremor

What may interact with this medicine?

Interactions have not been studied.

Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What if I miss a dose?

This does not apply.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of stroke

• infection

• inflammatory disorder

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• recently received or scheduled to receive a vaccination

• seizures

• an unusual or allergic reaction to axicabtagene ciloleucel, other medicines, foods, dyes, or preservative

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

You may need blood work done while you are taking this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Do not give blood while taking this medicine.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.