Brexucabtagene Autoleucel
Brexucabtagene Autoleucel is a CD19-directed chimeric antigen receptor (CAR) T cell therapy used to treat adults with relapsed or refractory mantle cell lymphoma (MCL) or B-cell acute lymphoblastic leukemia (ALL). The treatment involves collecting a patient's own T cells, genetically engineering them to target and kill cancer cells expressing the CD19 protein, then reinfusing them back into the patient.
Brexucabtagene Autoleucel is a personalized CAR-T cell therapy that reprograms a patient's own immune cells to target and destroy CD19-positive cancer cells in relapsed or refractory B-cell malignancies.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01XL06
- RxNorm
- 2387277
- Generic
- Brexucabtagene Autoleucel
- Class
- atc-l01
- Brands
- Tecartus
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 2 x 10^6 CAR-positive viable T cells per kg (maximum 2 x 10^8 CAR-positive viable T cells)
- Maximum
- consult physician
- Frequency
- single infusion
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 1 x 10^6 CAR-positive viable T cells per kg
- Maximum
- consult physician
- Frequency
- single infusion
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 2 x 10^6 CAR-positive viable T cells per kg (maximum 2 x 10^8 CAR-positive viable T cells)
- Maximum
- consult physician
- Frequency
- single infusion
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
generalavoid if possible
avoid use during pregnancy due to live cell therapy containing genetically modified autologous T-cells; potential risk of fetal harm and maternal complications
regular fetal monitoring and obstetric assessment if exposure occurs
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
first trimesteravoid
contraindicated in first trimester due to potential teratogenic effects and risk of miscarriage
comprehensive fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
generaldiscontinue breastfeeding
breastfeeding should be avoided during treatment and for some time after infusion due to potential transfer of cellular components
no specific monitoring required but lactation should be suppressed during treatment
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
adolescents 12 17individualize dosing
use only in clinical trials or as per approved pediatric indications; limited efficacy and safety data in patients under 18
close monitoring for cytokine release syndrome and neurotoxicity
Use with caution and monitor for adverse effects.
geriatric
age 65 and olderno specific adjustment required
use with caution in patients over 65; higher risk of cytokine release syndrome and neurologic events reported in elderly
enhanced monitoring for cytokine release syndrome, neurotoxicity, and infections; baseline cardiac and pulmonary assessment
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentno specific adjustment
use with caution; drug is not renally cleared but patients may have increased infection risk; ensure adequate renal function monitoring
monitor renal function, electrolytes, and for signs of infection
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severeno specific adjustment
use with caution; hepatic impairment may affect metabolism of lymphodepleting chemotherapy given prior to infusion
monitor liver function tests, bilirubin, and for signs of hepatotoxicity
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Gene therapy classification based on mechanism of action
Primary indications
Approved therapeutic indications
Manufacturer
Marketing authorization holder
Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) and relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is used when cancer has returned or not responded to prior therapies.
Brexucabtagene Autoleucel is an autologous immunotherapy where patient T cells are collected, genetically modified to express a chimeric antigen receptor (CAR) targeting the CD19 protein found on B cells, and reinfused. Upon engagement with CD19-expressing cells, the CAR T cells trigger immune activation through CD28 and CD3-zeta signaling domains, leading to cancer cell destruction.
Administered as a single infusion. Associated with serious risks including cytokine release syndrome (CRS) and neurotoxicity. Requires hospitalization for monitoring. May cause prolonged cytopenias, infections, and hypogammaglobulinemia. Safety monitoring and specialized facilities experienced in CAR-T administration are required.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy