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Tecartus
Brexucabtagene Autoleucel
$694995.00
29G · 1
BrandBranded medicine· By Kite Pharma
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FDA boxed warningCytokine release syndrome, neurologic toxicities, and secondary hematological malignancies
Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including life-threatening reactions, occurred in patients receiving TECARTUS, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with TECARTUS. 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.
About Tecartus
Overview
Tecartus (brexucabtagene autoleucel) is an immunotherapy made from a patient’s own genetically modified T cells. It is used to treat adults with mantle cell lymphoma or B-cell precursor acute lymphoblastic leukemia that has returned or has not responded to treatment. The modified T cells recognise and kill cells carrying a protein called CD19, including cancer cells and normal B cells.
What it treats
- Mantle cell lymphoma (MCL) in adults whose disease has returned or has not responded to treatment. - B-cell precursor acute lymphoblastic leukemia (ALL) in adults whose disease has returned or has not responded to treatment.
Safety information
Side effects
Common side effects include fever, chills, tiredness, nausea, headache, muscle or joint pain, diarrhea, constipation, reduced appetite, rash, swelling, tremor, a fast heartbeat and low blood pressure. Cough, shortness of breath, sleep problems and vomiting are also listed; which effects are common varies between the patient groups studied. Serious side effects, some of which are also common, warrant prompt contact with a doctor. These include: • Cytokine release syndrome (CRS), a serious immune reaction. • Effects on brain function, including difficulty speaking or problems with movement. • Severe infections, including viral infections, and fever with low levels of infection-fighting white blood cells. • Low oxygen levels or fluid around the lungs. • Severe reductions in blood cell counts that may last for several weeks after treatment. • Low antibody levels, which may require replacement treatment. • Hypersensitivity reactions during infusion. • Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), a serious immune-system reaction. The label also warns about secondary cancers. T-cell cancers have occurred after treatment with this type of genetically modified T-cell therapy. Monitoring after treatment includes checks for infections, blood cell counts and antibody levels.
FDA boxed warning
Cytokine release syndrome, neurologic toxicities, and secondary hematological malignancies
Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including life-threatening reactions, occurred in patients receiving TECARTUS, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with TECARTUS. 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.
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 FDA label lists no contraindications for Tecartus. Conditions requiring caution and monitoring include severe infections, allergic reactions during infusion, prolonged low blood cell counts, and low immunoglobulin levels. Blood counts and immunoglobulin levels should be monitored, with treatment or replacement therapy as needed. Hemophagocytic lymphohistiocytosis/macrophage activation syndrome, a serious inflammatory condition, requires treatment according to the treatment centre’s standards. Secondary cancers, including T-cell cancers, have occurred after this type of genetically modified T-cell treatment. Any secondary cancer after Tecartus treatment should be reported to Kite.
Using Tecartus
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 TECARTUS (BREXUCABTAGENE AUTOLEUCEL) SUSPENSION [KITE PHARMA, INC.] (DailyMed, retrieved 19 September 2026).
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