Tisagenlecleucel suspension for injection

What is this medication?

TISAGENLECLEUCEL (tis’’ a jen” lek loo’ sel) is a gene therapy that is made from cells in your immune system. It is used to treat acute lymphoblastic leukemia and certain types of non-Hodgkin lymphoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): KYMRIAH

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
• an unusual or allergic reaction to tisagenlecleucel, other medicines, foods, dyes, or preservative
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting. This medication is made from your own immune cells. Your cells will be collected approximately 3 to 4 weeks before the infusion of this medication.

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 care team regarding 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.

What may interact with this medication?

• live 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.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness 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. This drug decreases your body's ability to fight infections. Do not treat yourself. Try to avoid being around people who are sick.

Do not donate blood, organs, tissues, sperm, or oocytes while 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.

Do not become pregnant while taking this medication. Women should inform their care team if they wish to become pregnant or think they might be pregnant. There is a potential for serious harm to an unborn child. Talk to your care team for more information.

What side effects may I notice from receiving this medication?

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
• diarrhea
• loss of balance or coordination
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
• muscle pain or joint pain
• nausea, vomiting
• seizures
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls
• 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
• swelling in your legs and 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.

Where should I keep my medication?

This drug is given in a hospital or clinic and 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.