Pronunciation: kim-RY-uh
Generic name: tisagenlecleucel
Other brand names of tisagenlecleucel include: Kymriah (Ped ALL), Kymriah (DLBCL)
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 1, 2025.

What is Kymriah?

Kymriah is used to treat B-cell precursor acute lymphoblastic leukemia (ALL), large B-cell lymphoma, and follicular lymphoma. It is a personalized cancer treatment that is made from your T-cells and is given as a one-time intravenous infusion over approximately 1 hour. You may receive chemotherapy for a few days before you receive Kymriah, to prepare your body for the infusion.

Kymriah is created through a process where physicians extract T-cells from the patient, which are then transported to a specialized facility. At this facility, the T-cells undergo genetic modification to incorporate a chimeric antigen receptor (CAR). This modification enhances the T-cells' capacity to recognize and bind to cancer cells expressing the CD19 protein. After binding occurs, the modified T-cells destroy the cancer cells, thereby boosting the patient's immune response against the disease. Kymriah belongs to the drug class called CAR T-cell immunotherapy.

Kymriah (tisagenlecleucel) first gained FDA approval on August 30, 2017, and was the first CAR T-cell treatment to be developed, invented by a research team led by Dr. Carl June at the University of Pennsylvania in collaboration with Novartis. Approval was based on positive results from the following clinical trials:

• ELIANA (NCT02435849). Phase 2 trial in children and adolescents up to 25 years with relapsed or refractory (r/r) B-cell ALL. Key results: 82% overall response rate.
• JULIET (NCT02445248). Phase 2 trial in adults with r/r DLBCL patients. Key results: 81% complete remission rate with 59% 12-month relapse-free survival in 75 infused patients.
• ELARA trial (NCT03568461). Phase 2 in adults with r/r FL. Key results: 86% overall response rate and 66% complete response rate after a median 17-month follow-up, leading to FDA accelerated approval in May 2022.

FDA approvals and uses

Kymriah is FDA-approved to treat:

• B-cell precursor acute lymphoblastic leukemia (ALL) in patients up to 25 years that is refractory or in second or later relapse
• Relapsed or refractory (r/r) large B-cell lymphoma after 2 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 in adults. 
• R/r follicular lymphoma after 2 or more lines of systemic therapy in adults.
  • This indication is approved under accelerated approval based on response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Kymriah is not indicated for primary central nervous system lymphoma.

Side effects

The most common side effects of Kymriah are:

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

Serious side effects and warnings

Kymriah carries a Boxed Warning for cytokine release syndrome, neurological toxicities, and secondary blood cancers.

• Cytokine release syndrome (CRS) is a potentially fatal, acute systemic inflammatory response that occurs when the immune system releases excessive amounts of cytokines into the bloodstream. Seek urgent medical attention if you develop a fever, chills, difficulty breathing, body aches, vomiting, diarrhea, or feel fatigued or light-headed. 
• Kymriah can cause significant neurological toxicities, such as encephalopathy, seizures, and headaches, primarily as part of a condition called Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Seek urgent medical attention if you or the person you are caring for becomes confused, agitated, delirious, has altered or decreased consciousness, seizures, difficulty speaking and understanding, or loss of balance.
• T-cell cancer risk: Rarely, the modified immune cells used in treatment can themselves become cancerous, creating a new type of blood cancer different from the original disease being treated.

You may be admitted to the hospital and treated with other medications if you have any of these side effects. If you are admitted to the hospital, tell the healthcare provider that you have received Kymriah. 

Call or see your healthcare provider or get emergency help right away if you get any of the following:

• fever (100.4°F/38°C or higher)
• difficulty breathing
• chills or shaking chills
• confusion
• dizziness or lightheadedness
• severe nausea, vomiting, or diarrhea
• fast or irregular heartbeat
• severe fatigue or weakness.

Kymriah can cause the following other serious side effects:

• Allergic Reactions: Serious allergic reactions, including anaphylaxis, which is a life-threatening allergic reaction, may occur after you receive Kymriah. Some signs and symptoms may include difficulty breathing, very low blood pressure, dizziness, swelling under the skin, rash, nausea, and vomiting. You should seek emergency medical treatment right away if you have an allergic reaction
• Serious Infections: Kymriah can increase the risk of life-threatening infections that may lead to death. Tell your health care provider right away if you develop fever, chills, or any signs or symptoms of an infection
• Prolonged Low Blood Cell Counts (Cytopenias): Kymriah can lower 1 or more types of your blood cells (red blood cells, white blood cells, or platelets). After treatment, your health care provider may test your blood to check cell counts. Tell your health care provider right away if you get a fever or other symptoms of an infection, are feeling tired, weak, or short of breath, or have unusual bruising or bleeding
• Hypogammaglobulinemia: A condition in which the level of immunoglobulins (antibodies) in your blood is low and the risk of infection is increased. It is expected that you may develop hypogammaglobulinemia with Kymriah, and you may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Tell your healthcare provider about your treatment with Kymriah before receiving a live vaccine
• Hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) is a severe, life-threatening hyperinflammatory syndrome characterized by excessive immune activation, leading to tissue damage, multiorgan failure, and often death if untreated. Be sure to discuss with your health care provider the possibility of developing this life-threatening condition, and thereafter, your doctor will monitor you for the possibility of developing HLH/MAS
• Secondary Cancers: Kymriah may increase your risk of getting cancers, including certain types of blood cancers. Your health care provider should monitor you for this.

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

Tell all your healthcare providers that you have received Kymriah. Your healthcare providers may give you other medicines to treat your side effects. 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 Kymriah is safe for you, tell your doctor if you:

• neurologic problems (such as seizures, stroke, or memory loss)
• lung or breathing problems
• heart problems
• liver problems
• kidney problems
• a recent or active infection
• are pregnant or intend 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 Kymriah and chemotherapy.

If you receive Kymriah 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 Kymriah. Ask your doctor about any risks.

How is Kymriah administered?

Since Kymriah is made from your 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 frozen and sent to the manufacturing site to make Kymriah.

• 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 Kymriah to be made, your healthcare provider may give you therapy to stabilize your cancer.

• In addition, before you get Kymriah, 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 Kymriah 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 Kymriah. 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.

Kymriah dosing information

Dose of Kymriah for B-cell ALL (up to 25 years of age)

• 50kg or less: 0.2 to 5.0 x 10⁶ CAR-positive viable T-cells per kg body weight intravenously.
• Above 50kg: 0.1 to 2.5 x 10⁸ total CAR-positive viable T-cells suspended in one to three patient-specific infusion bags for intravenous infusion.

Dose of Kymriah for r/r diffuse large B-cell lymphoma or follicular lymphoma (adults)

• 0.6 to 6.0 x 10⁸ CAR-positive viable T-cells suspended in one to three patient-specific infusion bags for intravenous infusion.

What should I avoid after receiving Kymriah?

Avoid driving for at least 2 weeks after you get Kymriah.

Do not donate blood, organs, tissues, sperm, oocytes, or other cells. 

What other drugs will affect Kymriah?

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

Kymriah is manufactured by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. Facilities for Kymriah manufacture include Morris Plains, New Jersey, USA; Stein, Switzerland; Les Ulis, France; and Japan.

Kymriah 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 Kymriah.

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Further information

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