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 Jun 12, 2025.

What is Kymriah?

Kymriah is used to treat relapsing or refractory acute lymphoblastic leukemia (ALL) in patients up to 25 years old, and large B-cell lymphoma and follicular lymphoma in adults.

Kymriah (tisagenlecleucel) is a personalized, prescription immunotherapy treatment made from a person's own white blood cells, called CAR-T cell therapy, given as a one-time intravenous infusion. It gained FDA approval on August 30, 2017.

FDA approvals and uses

Kymriah is FDA-approved to treat:

• B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse in children and young adults up to 25 years old
• Relapsed or refractory 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. Not indicated for primary central nervous system lymphoma.
• Relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy in adults.
  • This indication is approved under the accelerated approval designation, and continued approval may be contingent upon a continued benefit being shown in clinical trials.

How is Kymriah made, and how does it work?

The process of making Kymriah begins by collecting a patient's T cells (a type of white blood cell) through a procedure called leukapheresis that takes 3 to 6 hours.

• These T cells are then frozen and sent to a manufacturing facility where they are genetically modified to express a chimeric antigen receptor (CAR) on their surface.
• This CAR specifically recognizes CD19, a protein found on the surface of B cells, including cancerous B cells.
• The modified T cells are then grown in a laboratory to increase their numbers.
• This part of the process takes 3 to 4 weeks.

The modified T-cells are then returned to the patient's healthcare provider in up to 3 infusion bags. 

• You may receive chemotherapy to prepare your body to receive the infusion.
• The modified T cells are infused through a vein into your bloodstream.
• The T cells recognize and bind to the CD19 protein on cancerous B cells, releasing cytokines and cytotoxic molecules that kill the cancer cells. 
• The CAR-T cells multiply in the body and can persist for months or even years, continuing to monitor and attack cancer cells.

How effective is Kymriah?

Clinical trials report survival rates of:

• Follicular lymphoma: 87.7% survival at 24 months
• Aggressive B-cell non-Hodgkin’s lymphoma: 43.6% survival at 24 months
• Advanced B-cell acute lymphoblastic leukemia: 55% 5-year survival rate.

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.

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.
• There is a risk of secondary blood cancers or cancer recurrence with Kymriah. Undergo recommended screenings, and tell all your healthcare providers you have received Kymriah. 

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 health care provider that you have received Kymriah.

Because of risk of CRS and neurological toxicities, Kymriah is administered under a Risk Evaluation and Mitigation Strategy (REMS) program, and patients are closely monitored, especially during the first few weeks after treatment.

Kymriah can cause the following other serious side effects:

• 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
• 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
• 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
• Effects on Ability to Drive and Use Machines: Do not drive, operate heavy machinery, or do other dangerous things for 8 weeks after you get Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.

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:

• 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.

Kymriah 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.

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

Pediatric and young adult 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 intravenously (non-weight based).

Adult relapsed or refractory diffuse large B-cell lymphoma or follicular lymphoma

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

What should I avoid after receiving Kymriah?

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

Do not donate blood, an organ, or any tissues or cells.

Do not receive a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and the nasal flu (influenza) vaccine.

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, a global pharmaceutical company.

Novartis is headquartered in Basel, Switzerland. The company was formed in 1996 through the merger of Ciba-Geigy and Sandoz, two Swiss companies with long histories in the pharmaceutical industry.

For Kymriah specifically, Novartis has several manufacturing facilities around the world:

• The initial FDA approval for Kymriah manufacturing was for their facility in Morris Plains, New Jersey, USA
• They later expanded manufacturing to include facilities in:
  • Stein, Switzerland
  • Les Ulis, France
  • 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.

Popular FAQ

View more FAQ

Further information

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

Medical Disclaimer