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Epcoritamab

Published: July 26, 2026Updated: July 26, 2026

Epcoritamab is a bispecific T-cell engaging antibody used to treat certain types of relapsed or refractory non-Hodgkin lymphoma, particularly diffuse large B-cell lymphoma (DLBCL). It works by binding simultaneously to CD20 on cancer cells and CD3 on T-cells, redirecting the immune system to recognize and destroy malignant B-cells.

Quick summary

Epcoritamab is a targeted immunotherapy that bridges T-cells with cancer cells to treat relapsed or refractory B-cell lymphomas.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

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
L01FX27
RxNorm
2637392
Generic
Epcoritamab
Class
atc-l01
Brands
Epkinly
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

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose significantly exceeding recommended maximum dosing that may cause serious immune-mediated toxicity
Chronic overdose: cumulative doses above recommended schedule leading to sustained immune-related adverse events
Immediate actions
discontinue drug administration, supportive care including intravenous fluids, tocilizumab or steroids as indicated, monitor vital signs
Antidote
tocilizumab (IL-6R antagonist)(highly effective for CRS management when administered promptly)
Poison Control: 1-800-222-1222

Special Populations

10 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular fetal monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

second trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular fetal monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular fetal monitoring and uterine activity monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

?

lactation

breastfeeding
unknown
FDA Category
N
Dose Adjustment

discontinue breastfeeding or avoid

Key Recommendations

it is unknown whether epcoritamab is excreted in human milk

Monitor

monitor infant for adverse effects

✗

pediatric_age

children under 18
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

epcoritamab is not approved for use in pediatric patients

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly 65 and older
caution
FDA Category
N
Dose Adjustment

no specific dose adjustment required

Key Recommendations

use with caution due to increased susceptibility to adverse reactions

Monitor

close monitoring for adverse reactions and cytokine release syndrome

Use with caution and monitor for adverse effects.

✓

renal_impairment

mild to moderate
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

no clinically significant effect on pharmacokinetics expected

Monitor

standard monitoring

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

limited data available in severe renal impairment

Monitor

close monitoring for adverse reactions

Use with caution and monitor for adverse effects.

✓

hepatic_impairment

mild
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

not metabolized by hepatic CYP enzymes

Monitor

standard monitoring

⚠

hepatic_impairment

moderate to severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

limited data available in moderate to severe hepatic impairment

Monitor

close monitoring for adverse reactions

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classFDA
2023

Drug class

Value:Bispecific CD20xCD3 antibody

Immunotherapy drug class classification

regulatoryFDA
2023

FDA approval year

Value:2022

FDA approval for relapsed or refractory diffuse large B-cell lymphoma

usageFDA
2023

Common uses

Value:Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Primary therapeutic indication

mechanismFDA
2023

Mechanism of action

Value:Binds to CD20 on B-cells and CD3 on T-cells to induce T-cell mediated cytotoxicity

Pharmacodynamic mechanism

Epcoritamab is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have received two or more prior lines of systemic therapy.

Epcoritamab is a bispecific antibody that simultaneously binds to CD20 on the surface of B-cells (including cancer cells) and CD3 on the surface of T-cells. This dual binding bridges cancer cells with immune cells, activating T-cells to release cytotoxic substances that destroy the malignant B-cells.

Epcoritamab is administered via subcutaneous injection and carries risks of serious side effects including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and infections. Patients require monitoring during and after administration. It targets both malignant and healthy B-cells, potentially causing B-cell depletion.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

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.

Medical Disclaimer

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