tisagenlecleucel 0.2 x10exp6 to 2.5x10exp8 cell intravenous suspension

Generic name:
Tisagenlecleucel - injection

Pronunciation
(TIS-a-JEN-lek-LOO-sel)

Brand name(s)
Kymriah

This medication may cause a serious (even fatal) reaction called cytokine release syndrome-CRS. Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection. Tell your doctor right away if you have any symptoms of CRS such as high fever, difficulty breathing, chills/shaking chills, severe nausea/vomiting/diarrhea, severe muscle/joint pain, very low blood pressure, dizziness/lightheadedness.

Serious nerve problems can occur after treatment with tisagenlecleucel. Tell your doctor right away if you have trouble speaking and understanding, loss of balance, or mental/mood changes such as anxiety, confusion, agitation.

Tisagenlecleucel is used to treat certain types of cancer (acute lymphoblastic leukemia-ALL, B-cell lymphoma, follicular lymphoma). This type of treatment is known as gene therapy. Tisagenlecleucel is made from your own white blood cells and is given only to you. The white blood cells have been changed to have a specific protein (chimeric antigen receptor-CAR) that helps your body slow or stop the growth of certain cancer cells.

Read the Medication Guide provided by your healthcare professional before you start using this product. If you have any questions, ask your healthcare professional(s).

Before you get treatment with this product, your doctor may give you chemotherapy for a few days to prepare your body.

This product is given by slow injection into a vein as directed by your doctor, usually over less than one hour. To decrease the risk of side effects, your doctor may also give you other medications (such as acetaminophen, diphenhydramine) before injecting tisagenlecleucel. The dosage is based on your medical condition and weight. You should plan to stay for at least 4 weeks near the place of your treatment (for example, within 2 hours' drive). Your doctor will check to see if your treatment is working and help you manage any side effects.

See also Warning section.

Headache, tiredness, or loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Although tisagenlecleucel is used to treat cancer, it may rarely increase your risk of developing other cancers. Also, this product may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection and any infection you have may get worse. Tell your doctor right away if you develop unusual growths or lumps, swollen glands, signs of infection (such as a sore throat that doesn't go away, fever, chills), easy or unusual bruising/bleeding, or unusual tiredness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving tisagenlecleucel, tell your doctor or pharmacist if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• past/current/recent infection (including hepatitis, HIV)
• bleeding/blood problems

This product can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using tisagenlecleucel before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy, affect your coordination, or make it harder for you to think clearly. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely (at least 8 weeks after receiving treatment is recommended by the manufacturer). Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using tisagenlecleucel. Tisagenlecleucel may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this product passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This product may interfere with certain lab tests (such as some HIV tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood counts) should be done before and after you receive this product. Keep all medical and lab appointments.

If your dose is interrupted or stopped, ask your doctor or pharmacist right away for a new dosing schedule.

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

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.