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Retifanlimab

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

Retifanlimab is an immunotherapy medication that belongs to a class of drugs called checkpoint inhibitors. It works by blocking the PD-1 receptor on T cells, allowing the immune system to better recognize and attack cancer cells. This medication is used to treat adults with metastatic or recurrent locally advanced Merkel cell carcinoma, a rare and aggressive form of skin cancer.

Quick summary

Retifanlimab is a PD-1 inhibitor immunotherapy used to treat certain cancers by helping the immune system attack tumor cells.

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

Key facts at a glance

ATC
L01FF10
RxNorm
2632981
Generic
Retifanlimab
Class
atc-l01
Brands
Zynyz
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)intravenous infusion
Usual dose
500mg
Maximum
consult physician
Frequency
every 4 weeks
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)intravenous infusion
Usual dose
Not established
Maximum
consult physician
Frequency
N/A
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)intravenous infusion
Usual dose
500mg
Maximum
consult physician
Frequency
every 4 weeks
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose exceeding recommended therapeutic dose that may lead to severe immune-related adverse events
Chronic overdose: Cumulative doses above recommended regimen may increase risk of severe immune-mediated toxicity
Immediate actions
Discontinue drug, initiate corticosteroid therapy, provide supportive care, monitor vital signs and organ function
Antidote
No specific antidote available(Management focuses on immunosuppression with corticosteroids and supportive care)
Poison Control: 1-800-222-1222

Special Populations

8 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks; discuss potential fetal harm with patients of reproductive potential

Monitor

regular fetal monitoring

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

✗

pregnancy

second third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid

Key Recommendations

discontinue treatment if pregnancy occurs; advise women to avoid becoming pregnant during treatment

Monitor

fetal ultrasounds as clinically indicated

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

?

lactation

breastfeeding
unknown
FDA Category
N
Dose Adjustment

discontinue

Key Recommendations

do not breastfeed during treatment and for at least 4 months after last dose

Monitor

none established

⚠

geriatric

elderly 65
caution
FDA Category
N
Dose Adjustment

no specific adjustment

Key Recommendations

use with caution; monitor for adverse reactions; no overall differences in efficacy observed but increased susceptibility to immune-mediated adverse reactions

Monitor

regular monitoring for immune-mediated adverse events

Use with caution and monitor for adverse effects.

?

pediatric_age

children adolescents
unknown
FDA Category
N
Dose Adjustment

not established

Key Recommendations

safety and efficacy not established in pediatric patients; use only in clinical trials when specifically indicated

Monitor

not established

⚠

renal_impairment

mild moderate
caution
FDA Category
N
Dose Adjustment

no dose adjustment

Key Recommendations

no dose adjustment needed for mild to moderate renal impairment; monitor renal function

Monitor

regular renal function monitoring

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

limited data in severe renal impairment; use only if benefits outweigh risks

Monitor

close renal function monitoring

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild moderate
caution
FDA Category
N
Dose Adjustment

no dose adjustment

Key Recommendations

no dose adjustment needed for mild to moderate hepatic impairment; monitor liver function

Monitor

regular liver function tests

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classFDA
2023

Drug class

Value:PD-1 inhibitor

Immunotherapy class information

prescribingFDA
2023

FDA approval year

Value:2023

FDA approval for Zynyz (Retifanlimab)

usageFDA
2023

Common uses

Value:Merkel cell carcinoma

Indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma

mechanismFDA
2023

Mechanism of action

Value:PD-1 blockade

Binds to PD-1 receptor and blocks its interaction with PD-L1 and PD-L2

Retifanlimab is approved for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). It is used when the cancer has spread or returned after prior treatment.

Retifanlimab is a monoclonal antibody that binds to the PD-1 receptor on T cells, blocking interaction with PD-L1 and PD-L2 ligands. This prevents tumor cells from using the PD-1 pathway to suppress immune responses, restoring T-cell function to recognize and destroy cancer cells.

Common side effects may include fatigue, rash, fever, and immune-related adverse reactions affecting various organs. Patients should be monitored for immune-mediated side effects, which may require treatment interruption or corticosteroids. Use during pregnancy is not recommended.

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