Brexucabtagene autoleucel is a prescription medicine indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), among other approved uses. It is available as injectable suspension for intravenous use. MedsAcross supplies Brexucabtagene autoleucel for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Source: US FDA prescribing information
TECARTUS, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.
Source: US FDA prescribing information
For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter. Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of TECARTUS. Verify the patient's identity prior to infusion. Premedicate with acetaminophen and diphenhydramine. Confirm availability of tocilizumab prior to infusion. Dosing of TECARTUS is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. MCL: dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells. ALL: dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
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. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome: Administer treatment per institutional standards. Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. Severe Infections: Monitor patients for signs and symptoms of infection, treat appropriately. Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following TECARTUS infusion. Monitor complete blood counts.
Source: US FDA prescribing information
The most common non-laboratory adverse reactions (incidence greater than or equal to 20%) are: MCL: CRS, fever, encephalopathy, hypotension, infection with pathogen unspecified, viral infections, fatigue, tachycardias, chills, hypoxia, tremor, cough, musculoskeletal pain, nausea, edema, headache, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, motor dysfunction. ALL: fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.
Source: US FDA prescribing information
TECARTUS is supplied in a liquid nitrogen dry shipper at ≤ -150°C. At the treatment center, store TECARTUS frozen at ≤ -120°C (in a mechanical freezer or in the vapor phase of liquid nitrogen) up to the labeled expiration date. TECARTUS may be transferred from vapor phase of liquid nitrogen to mechanical freezer storage at ≤ -120°C only once and cannot be transferred back. TECARTUS may be stored at the treatment center for a single time at -80°C (+/- 10°C), for up to 90 days, and not exceeding the labeled expiration date. Do not return TECARTUS to storage at ≤ -120°C after storage at -80°C.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Brexucabtagene autoleucel, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tecartus 1000000/68 mL injectable suspensionIntravenous Cold chain | Kite Pharma | US FDA | Available on request |
| Tecartus 2000000/68 mL injectable suspensionIntravenous Cold chain | Kite Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Brexucabtagene autoleucel and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Brexucabtagene autoleucel, including Tecartus.
Yes. Brexucabtagene autoleucel has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Brexucabtagene autoleucel must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Brexucabtagene autoleucel is classified under ATC code L01X (Cancer medicines (antineoplastics), subgroup L01X).
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