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KYMRIAH
Tisagenlecleucel
$599375.00
1
BrandBranded medicine· By Novartis
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FDA boxed warningCytokine release syndrome, neurological toxicities, and secondary hematological malignancies
Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids
Neurological toxicities, including severe or life-threatening reactions, occurred following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care and/or corticosteroids as needed
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including KYMRIAH
About KYMRIAH
Overview
KYMRIAH (tisagenlecleucel) is an immunotherapy made from a patient’s own genetically modified T cells. It treats B-cell precursor acute lymphoblastic leukemia (ALL) in patients up to age 25 when the disease has not responded to treatment or has returned for a second or later time, and large B-cell lymphoma or follicular lymphoma in adults when the disease has returned or not responded after at least two courses of systemic treatment. It is not indicated for primary central nervous system lymphoma, and its accelerated approval for follicular lymphoma may depend on further trials confirming clinical benefit. It works by modifying the patient’s T cells to recognize and destroy cells carrying a protein called CD19, including cancerous and normal cells.
What it treats
- B-cell precursor acute lymphoblastic leukemia (ALL) in patients up to 25 years old that has not responded to treatment or has returned for the second or a later time. - Large B-cell lymphoma in adults that has returned or not responded 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. KYMRIAH is not indicated for primary central nervous system lymphoma. - Follicular lymphoma in adults that has returned or not responded after two or more lines of systemic therapy. This indication has accelerated approval based on response rate and duration of response; continued approval may depend on confirmation of clinical benefit in further trials.
Safety information
Side effects
Common side effects vary by cancer type and age group. Those reported in more than 20% of patients in at least one group include cytokine release syndrome (CRS), infections, fever, headache, diarrhea, nausea, fatigue, low blood pressure, swelling, bleeding, and muscle, bone or joint pain. Shortness of breath was also common in adults with diffuse large B-cell lymphoma. In children and young adults with B-cell acute lymphoblastic leukemia, other common side effects included low antibody levels, reduced appetite, vomiting, changes in brain function, cough, pain, low blood oxygen, fast heartbeat, acute kidney injury, and fever with low levels of infection-fighting white blood cells. Serious effects that warrant prompt medical attention include CRS, serious infections, allergic reactions during the infusion, changes in brain function, bleeding, breathing difficulties and acute kidney injury. Severe reductions in blood cell counts can last for several weeks after treatment. Prolonged low white blood cell counts increase the risk of infection. Low antibody levels require monitoring and may need replacement treatment until they recover. Secondary cancers, including T-cell cancers, have occurred after treatment with KYMRIAH and related T-cell therapies. Contact your treating doctor promptly about suspected serious side effects or a new cancer diagnosis.
FDA boxed warning
Cytokine release syndrome, neurological toxicities, and secondary hematological malignancies
Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids
Neurological toxicities, including severe or life-threatening reactions, occurred following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care and/or corticosteroids as needed
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including KYMRIAH
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The supplied FDA label lists no contraindications for KYMRIAH. Important precautions include allergic reactions during infusion, serious infections, and severe low blood cell counts that may last for several weeks. Prolonged low neutrophil counts can increase the risk of infection. Monitoring is needed for allergic reactions and signs of infection. KYMRIAH may also cause low immunoglobulin levels, requiring monitoring and replacement therapy until they recover. Immunoglobulin levels should be checked in newborns whose mothers have received KYMRIAH. New cancers, including T-cell cancers, have occurred after treatment with genetically modified T-cell therapies, including KYMRIAH. If a new cancer develops after treatment, the treating team should contact Novartis Pharmaceuticals Corporation.
Interactions
KYMRIAH may cause a false-positive result on some HIV nucleic acid tests (NATs). Tell your doctor you have received KYMRIAH if you are having an HIV test.
Using KYMRIAH
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light. Do not freeze. Prepared infusions are handled by the treating clinic. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label KYMRIAH (TISAGENLECLEUCEL) INJECTION, SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] (DailyMed, retrieved 19 September 2026).
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