Axicabtagene Ciloleucel
Axicabtagene ciloleucel is a personalized cell therapy where a patient's own T cells are genetically engineered to target and destroy cancer cells expressing the CD19 protein. This treatment is used in adults with certain types of relapsed or refractory non-Hodgkin lymphoma who have not responded to or have relapsed after at least two prior therapies.
Axicabtagene ciloleucel is a CAR-T cell therapy that reprograms a patient's own immune cells to recognize and attack CD19-expressing cancer cells, used for relapsed or refractory B-cell lymphomas.
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
- L01XL03
- RxNorm
- 1987398
- Generic
- Axicabtagene Ciloleucel
- Class
- atc-l01
- Brands
- Yescarta
- 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 body weight (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
all trimestersavoid if possible
avoid use during pregnancy unless benefits outweigh risks; discuss potential fetal toxicity with patients of reproductive potential
regular fetal monitoring; verify pregnancy status before treatment
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid
discontinue breastfeeding during treatment and for at least 12 months after treatment with axicabtagene ciloleucel
no specific monitoring required
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyno specific adjustment
use with caution; no dose adjustment required but monitor for increased risk of cytokine release syndrome and neurotoxicity
close monitoring for cytokine release syndrome and neurological events; baseline assessment of organ function
Use with caution and monitor for adverse effects.
pediatric_age
pediatricnot applicable
not approved for use in pediatric patients under 18 years of age; safety and efficacy not established
not applicable
renal_impairment
severe renal impairmentno specific adjustment
use with caution; patients with severe renal impairment were excluded from clinical trials
monitor renal function before and after treatment; standard supportive care measures
Use with caution and monitor for adverse effects.
hepatic_impairment
severe hepatic impairmentno specific adjustment
use with caution; patients with severe hepatic impairment were excluded from clinical trials
monitor liver function tests before and after treatment; assess hepatic function parameters
Use with caution and monitor for adverse effects.
alcohol_users
alcohol use disorderno specific adjustment
use with caution; assess alcohol use history; consider potential for increased hepatotoxicity
monitor liver function tests; assess for hepatic toxicity
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Initial FDA approval date for adult patients with large B-cell lymphoma
Drug class
Classification as cellular immunotherapy
Primary indication
Approved therapeutic indication
Manufacturer
Marketing authorization holder
Treats relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma) and relapsed or refractory follicular lymphoma in adult patients who have received at least two prior systemic therapies.
Axicabtagene ciloleucel is an autologous CAR-T cell therapy. Patient T cells are collected, genetically modified to express a chimeric antigen receptor (CAR) targeting CD19, expanded, and then infused back into the patient. The CAR consists of an anti-CD19 single-chain variable fragment linked to CD28 and CD3-zeta signaling domains, enabling T cell activation against CD19-expressing cells upon binding.
This is a one-time, single-infusion treatment administered in a certified healthcare facility with experience managing cytokine release syndrome and neurological toxicities. Risk evaluation and mitigation strategies (REMS) are required due to potentially severe adverse reactions including cytokine release syndrome, neurological toxicities, infections, and prolonged cytopenias. Patients should be monitored closely following infusion.
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