BREYANZI contains the active ingredient lisocabtagene maraleucel, which is a CD19-directed genetically modified autologous T cell immunotherapy. It is formulated as a frozen suspension of CAR-positive T cells, administered intravenously after thawing. Key inactive ingredients include Cryostor CS10, Multiple Electrolytes for Injection, and human albumin. BREYANZI is prepared from a patient's own T cells, which are modified to target CD19-positive cells.

How should I use this medication?

This medication is infused into a vein. It is given by your care team in a hospital or clinic setting.

This therapy uses cells from your immune system.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
• Fever, rash, swollen lymph nodes, confusion, trouble walking, loss of balance or coordination, seizures
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
• Unusual bruising or bleeding

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

• Constipation
• Diarrhea
• Dizziness
• Fatigue
• Headache
• Muscle pain
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

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

• Heart disease
• Infection
• Kidney disease
• Liver disease
• Lung or breathing disease
• Nervous system problems such as seizures, stroke, or memory loss
• An unusual or allergic reaction to lisocabtagene maraleucel, other medicines, foods, dyes, or preservative
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Live virus vaccines

This list may not describe all possible interactions. 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 should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need blood work while you are taking this medication.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Do not donate blood while you are taking this medication.

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

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy. You will need a negative pregnancy test before starting this medication.

What are the most serious risks of this medication?

This medication may increase the risk of blood or bone marrow cancer. Your care team will monitor your blood work closely.

This medication can cause a serious side effect called cytokine release syndrome. Your care team will monitor you closely. Tell your care team right away if you feel faint or lightheaded or have fever, fatigue, loss of appetite, nausea, headache, shortness of breath, or a fast or irregular heartbeat.

This medication may affect the brain and nervous system. Talk to your care team right away if you have confusion, dizziness, tremors, trouble speaking, weakness, or pain, tingling, or numbness in the hands or feet. Some side effects can be severe. Call emergency services if you have seizures or trouble staying awake.