Lisocabtagene Maraleucel
Lisocabtagene Maraleucel is a CAR-T cell therapy designed to treat certain blood cancers by reprogramming a patient's own immune cells to target and destroy cancer cells. It is used in adults with relapsed or refractory large B-cell lymphoma and other B-cell malignancies after other treatments have failed. This therapy involves collecting the patient's T cells, genetically modifying them, and then infusing them back into the patient.
A personalized CAR-T cell therapy that uses modified patient immune cells to target and kill CD19-positive cancer cells.
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
- L01XL08
- RxNorm
- 2479136
- Generic
- Lisocabtagene Maraleucel
- Class
- atc-l01
- Brands
- Breyanzi
- 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
- 50 to 100 x 10^6 CAR-positive T cells
- Maximum
- consult physician
- Frequency
- single infusion
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not established
- Maximum
- consult physician
- Frequency
- not established
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 50 to 100 x 10^6 CAR-positive T cells
- Maximum
- consult physician
- Frequency
- single infusion
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks - discuss potential fetal harm with patient
regular fetal monitoring including ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks - consider alternative therapies first
regular fetal monitoring including growth assessments and ultrasound
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use during third trimester unless benefits significantly outweigh risks - consider early delivery if therapy is essential
regular fetal monitoring including non-stress tests and ultrasound for growth
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingno specific adjustment
breastfeeding not recommended during treatment and for at least 12 months after infusion - counsel patients to discard breast milk during treatment period
no specific monitoring required
pediatric_age
children adolescentsnot applicable - not approved for pediatric use
not approved for use in patients under 18 years of age - enrollment in clinical trials may be considered for specific age-appropriate indications
pediatric-specific monitoring protocols required in clinical trial settings
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 and olderno dose adjustment required
use with caution - increased risk of cytokine release syndrome and neurotoxicity in elderly - ensure adequate organ function and performance status before treatment
close monitoring for cytokine release syndrome and neurotoxicity - cardiac monitoring recommended
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentno dose adjustment required
use with caution - limited data in severe renal impairment - ensure patient can tolerate potential cytokine release syndrome
standard monitoring for cytokine release syndrome and neurotoxicity - monitor renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severe hepatic impairmentno dose adjustment required
use with caution - limited data in moderate to severe hepatic impairment - assess liver function and synthetic capacity before treatment
monitor liver function tests and signs of hepatotoxicity - standard monitoring for cytokine release syndrome and neurotoxicity
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
CAR-T cell therapy classification
FDA approval year
FDA approval timeline for Breyanzi
Common uses
Therapeutic indications
Administration route
Method of drug administration
Approved for adult patients with relapsed or refractory large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma who have received at least two prior lines of systemic therapy.
This is a CD19-directed autologous cell immunotherapy where the patient's T cells are collected, genetically engineered to express a chimeric antigen receptor (CAR) targeting the CD19 protein found on B cells, and then reinfused. The defined composition ensures consistent dosing of CD8+ and CD4+ T cells.
Administered as a single infusion. Requires careful monitoring for cytokine release syndrome (CRS) and neurological toxicities. Due to its personalized nature, it must be prepared specifically for each patient using their own cells. Pre-infusion lymphodepleting chemotherapy is required before administration.
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