KYMRIAH is an autologous T cell immunotherapy with the active ingredient tisagenlecleucel, formulated as a frozen cell suspension for intravenous infusion. It belongs to a class of CD19-directed genetically modified therapies and consists of patient-derived T cells modified with a lentiviral vector to express a chimeric antigen receptor. The formulation includes Plasma-Lyte A, Dextrose, Human Serum Albumin, and DMSO among other ingredients. It is intended to be tailored to each patient with specific dosages based on individual needs.

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. Your cells will be collected several weeks before you receive therapy. Your care team will give you chemotherapy several days before your infusion to help your body prepare for it.

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

Talk to your care team about the use of this medication in children. While it may be given to children for selected conditions, precautions do apply.

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):

• Diarrhea
• Fatigue
• Headache
• Loss of appetite
• Muscle pain
• Nausea
• Swelling of the ankles, hands, or feet

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:

• Infection
• Inflammatory disorder
• Recent or upcoming vaccine
• An unusual or allergic reaction to tisagenlecleucel, other medications, foods, dyes, or preservative
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• 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 done while you are taking this medication.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery for at least 8 weeks after your infusion. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

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, organs, tissues, or cells any time after receiving this treatment.

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

Talk to your care team if you may be pregnant. This medication has not been well studied during pregnancy. You will need a negative pregnancy test before starting this medication.