Tisagenlecleucel

Pronunciation: TIS-a-JEN-lek-LOO-sel
Generic name: tisagenlecleucel
Brand name: Kymriah
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 17, 2025.

What is tisagenlecleucel?

Tisagenlecleucel is used to treat acute lymphoblastic leukemia, large B-cell lymphoma, and follicular lymphoma. It is a CAR-T cell treatment made from your white blood cells that is given as a one-off intravenous infusion.

Tisagenlecleucel is not chemotherapy, it is an individualized, targeted immunotherapy treatment.

Tisagenlecleucel gained FDA approval on August 30, 2017, under the brand Kymriah. There is no generic or biosimilar.

FDA approvals and indications

Tisagenlecleucel is approved to treat:

• B-cell precursor acute lymphoblastic leukemia (ALL) that is either relapsing (went into remission, then came back) or refractory (did not go into remission after receiving other leukemia treatments) in patients aged up to 25 years.
• Large B-cell lymphoma that has relapsed or is refractory after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

The approval for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy is under the accelerated approval designation based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Tisagenlecleucel is not used to treat patients with primary central nervous system lymphoma.

Mechanism

Tisagenlecleucel is a type of cancer treatment called CAR T-cell therapy (CAR stands for chimeric antigen receptor). The way tisagenlecleucel works is:

• A healthcare provider collects your T-cells through a blood-filtering process called leukapheresis
• These T-cells are genetically modified in a laboratory to attach a specific protein to their surface that will attack cancer cells that have a specific marker called CD19
• These modified T-cells are then infused back into the patient. 

Tisagenlecleucel belongs to the drug class called CD19-directed genetically modified autologous T-cell
immunotherapy. It may also be called a CAR T-cell treatment.

Side effects

The most common side effects of tisagenlecleucel are:

• difficulty breathing
• fever (100.4°F/38°C or higher)
• chills and shakes
• confusion
• severe nausea, vomiting, or diarrhea
• muscle or joint pain
• very low blood pressure
• dizziness/lightheadedness
• headache.

Serious side effects and warnings

Tisagenlecleucel can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.

A serious side effect of tisagenlecleucel is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, body aches, vomiting, diarrhea, or feeling light-headed. Your caregivers will have medication available to quickly treat CRS if it occurs.

Tisagenlecleucel can lower one or more types of blood cells (red blood cells, white blood cells, or platelets). After treatment, your healthcare provider will test your blood to check for this.

• Tell your healthcare provider right away if you get a fever, are feeling tired, weak, or short of breath, or have bruising or bleeding.

Having tisagenlecleucel in your blood may cause a false-positive HIV test result by some commercial tests.

Tisagenlecleucel may increase your risk of getting cancers, including certain types of blood cancers. Your healthcare provider should monitor you for this.

Life-threatening nerve problems can happen with tisagenlecleucel. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, or a seizure.

Hypersensitivity reactions may occur with this treatment. Get emergency medical help if you have signs of an allergic reaction, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Tisagenlecleucel may cause other side effects that are severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following:

• difficulty breathing
• fever (100.4°F/38°C or higher)
• chills/shaking chills
• confusion
• severe nausea, vomiting, or diarrhea
• severe muscle or joint pain
• very low blood pressure
• dizziness/lightheadedness
• tremors, anxiety, agitation.

It is important that you tell your healthcare providers that you have received tisagenlecleucel. Your healthcare providers may give you other medicines to treat your side effects.

Tisagenlecleucel is only available through a restricted program called the Kymriah Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider will order it through a qualified Kymriah Treatment Center.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

To make sure tisagenlecleucel is safe for you, tell your doctor if you:

• have hepatitis B or C
• have HIV (human immunodeficiency virus)
• have received a vaccine in the past 2 weeks
• are pregnant or intending to become pregnant
• are breastfeeding.

Pregnancy

Females who can get pregnant may need pregnancy testing before receiving this medicine. You should also take birth control to prevent pregnancy during and shortly after treatment with tisagenlecleucel and chemotherapy.

If you receive tisagenlecleucel during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.

Breastfeeding

It may not be safe to breastfeed while using tisagenlecleucel. Ask your doctor about any risks.

How is tisagenlecleucel administered?

Since tisagenlecleucel is made from your own white blood cells, your healthcare provider has to take some of your blood.

• This is called “leukapheresis.”
• It takes 3 to 6 hours and may need to be repeated.
• A tube (intravenous catheter) will be placed in your vein to collect your blood.

Your blood cells are then frozen and sent to the manufacturing site to make tisagenlecleucel.

• It takes about 3-4 weeks from the time your cells are received at the manufacturing site and shipped back to your healthcare provider, but the time may vary.

While waiting for tisagenlecleucel to be made, your healthcare provider may give you therapy to stabilize your cancer.

• In addition, before you get tisagenlecleucel, your healthcare provider may give you chemotherapy for a few days to prepare your body.
• When your body is ready, your healthcare provider will give you tisagenlecleucel through a tube (intravenous catheter) in your vein. This usually takes less than one hour.
• Your doctor may give you premedication with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes before infusion. Avoid using corticosteroids at any time except in the case of a life-threatening emergency.
• See How is Kymriah administered? for more information.

You should plan to stay within 2 hours of the location where you received your treatment for at least 4 weeks after getting tisagenlecleucel. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

• Serious and sometimes fatal infections may develop after the injection. Call your doctor right away if you have a fever, chills, easy bruising, unusual bleeding, or other signs of infection.

Dosing information

B-cell lymphoma or follicular lymphoma

• Tisagenlecleucel 0.6 to 6.0 x 10⁸ CAR-positive viable T-cells intravenously.

B-cell precursor ALL

• Above 50kg: tisagenlecleucel 0.1 to 2.5 x 10⁸ total CAR-positive viable T-cells intravenously.
• 50kg or less: tisagenlecleucel 0.2 to 5.0 x 10⁶ CAR-positive viable T-cells per kg body weight intravenously

What happens if I miss a dose?

Call your doctor for instructions if you miss any of your chemotherapy treatment, or if you miss a dose of your premedications to prevent side effects of tisagenlecleucel.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving tisagenlecleucel?

Do not drive, operate machinery or partake in hazardous tasks for at least 8 weeks after receiving tisagenlecleucel.

Do not donate blood, an organ, or any tissues or cells from your own body.

Do not receive a "live" vaccine while using tisagenlecleucel, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect tisagenlecleucel?

Other drugs may interact with tisagenlecleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Manufacturer

Novartis Pharmaceuticals Corporation makes tisagenlecleucel under the brand name Kymriah. Novartis manufactures Kymriah (tisagenlecleucel) at several specialized facilities around the world including Morris Plains, New Jersey, USA.

Tisagenlecleucel Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for tisagenlecleucel.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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