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Avelumab

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

Avelumab is a monoclonal antibody immunotherapy drug that works by blocking the PD-L1 protein, helping the immune system recognize and attack cancer cells. It is used to treat certain cancers including Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma.

Quick summary

Avelumab is an immunotherapy drug that blocks PD-L1 to help the immune system fight certain cancers.

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

Key facts at a glance

ATC
L01FF04
RxNorm
1875534
Generic
Avelumab
Class
atc-l01
Brands
Bavencio
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 above recommended maximum may lead to severe immune-mediated toxicity
Chronic overdose: cumulative doses exceeding recommended treatment regimen may result in prolonged immune-related adverse events
Immediate actions
discontinue infusion immediately, initiate supportive care, monitor vital signs, administer corticosteroids as indicated
Antidote
no specific antidote available(supportive care and immune suppression are primary treatments; no targeted antidote exists)
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 to the fetus

Monitor

regular fetal monitoring and ultrasound assessments

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 if possible

Key Recommendations

discontinue therapy if pregnancy occurs or avoid initiating during pregnancy

Monitor

continuous fetal monitoring throughout pregnancy

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

✗

lactation

breastfeeding
contraindicated
FDA Category
N
Dose Adjustment

not applicable

Key Recommendations

discontinue breastfeeding during treatment and for at least 1 month after last dose

Monitor

not applicable

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

⚠

geriatric

elderly 65 plus
caution
FDA Category
N
Dose Adjustment

no specific dose adjustment required

Key Recommendations

use with caution due to increased susceptibility to immune-mediated adverse reactions

Monitor

enhanced monitoring for immune-related adverse events

Use with caution and monitor for adverse effects.

✗

pediatric_age

children under 12
unsafe
FDA Category
C
Dose Adjustment

not recommended

Key Recommendations

safety and efficacy not established in pediatric patients under 12 years

Monitor

not applicable - not recommended for use

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

⚠

pediatric_age

adolescents 12 17
caution
FDA Category
C
Dose Adjustment

dose individualization required

Key Recommendations

use only in approved pediatric indications; monitor closely for immune-mediated adverse events

Monitor

regular monitoring for immune-related adverse events and growth development

Use with caution and monitor for adverse effects.

✓

renal_impairment

mild moderate
safe
FDA Category
N
Dose Adjustment

no dose adjustment needed

Key Recommendations

no dose adjustment required for mild to moderate renal impairment

Monitor

routine renal function monitoring

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

no specific guidance available

Key Recommendations

use with caution; limited data available for severe renal impairment

Monitor

increased monitoring of renal function

Use with caution and monitor for adverse effects.

✓

hepatic_impairment

mild
safe
FDA Category
N
Dose Adjustment

no dose adjustment needed

Key Recommendations

no dose adjustment required for mild hepatic impairment

Monitor

routine liver function monitoring

⚠

hepatic_impairment

moderate severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

use with caution; limited data available for moderate to severe hepatic impairment

Monitor

frequent liver function tests and monitoring for hepatotoxicity

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2017

First FDA approval date for Avelumab

drug_classWHO
2023

Drug class

Value:PD-L1 inhibitor

Immunotherapy drug class information

usageMedical guidelines
2023

Common uses

Value:Merkel cell carcinoma, urothelial carcinoma, renal cell carcinoma

Approved therapeutic indications

mechanismFDA
2023

Mechanism of action

Value:Monoclonal antibody binding to PD-L1

Pharmacological mechanism

Avelumab is approved for treating metastatic Merkel cell carcinoma, locally advanced or metastatic urothelial carcinoma, and advanced renal cell carcinoma. It may be used alone or in combination with other therapies depending on the cancer type and stage.

Avelumab is a monoclonal antibody that binds to PD-L1 protein on tumor cells and immune cells. By blocking PD-L1 from interacting with PD-1 and B7.1 receptors on T cells, it removes the brake on the immune system, allowing T cells to recognize and destroy cancer cells.

Common side effects include fatigue, musculoskeletal pain, rash, nausea, and infusion-related reactions. Immune-related adverse events can affect various organs including lungs, liver, kidneys, and hormone-producing glands. Treatment requires careful monitoring by healthcare providers experienced with immunotherapy.

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