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Pembrolizumab

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

Pembrolizumab is an immunotherapy medication that works by blocking the PD-1 receptor on T cells, preventing tumor cells from using the PD-1 pathway to hide from the immune system. It is used to treat various cancers including melanoma, non-small cell lung cancer, Hodgkin lymphoma, bladder cancer, and head and neck cancers.

Quick summary

Pembrolizumab is a PD-1 inhibitor immunotherapy used to treat multiple types of cancer by helping the immune system recognize and attack tumor cells.

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

Key facts at a glance

ATC
L01FF02
RxNorm
1547545
Generic
Pembrolizumab
Class
atc-l01
Brands
Keytruda, Keytruda Qlex
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: No specific toxic single dose established; overdose may increase risk of immune-mediated adverse reactions
Chronic overdose: Cumulative dosing beyond recommended schedule may increase immune-related toxicities
Immediate actions
Discontinue drug, initiate corticosteroid therapy, provide supportive care, monitor vital signs
Antidote
No specific antidote available(Treatment is supportive and focuses on managing immune-related adverse events with immunosuppression)
Poison Control: 1-800-222-1222

Special Populations

7 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 third trimester
caution
FDA Category
C
Dose Adjustment

use only if benefits outweigh risks

Key Recommendations

consider risks vs benefits carefully

Monitor

fetal monitoring and assessment of maternal immune status

Use with caution and monitor for adverse effects.

✗

lactation

breastfeeding
unsafe
FDA Category
N
Dose Adjustment

discontinue breastfeeding

Key Recommendations

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

Monitor

not applicable

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

⚠

geriatric

elderly 65 years and older
caution
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

use with caution due to increased risk of immune-related adverse events

Monitor

close monitoring for adverse events

Use with caution and monitor for adverse effects.

⚠

pediatric_age

infants and young children
caution
FDA Category
N
Dose Adjustment

weight-based dosing

Key Recommendations

approved for use in pediatric patients 6 months and older for certain indications including classical Hodgkin lymphoma and MSI-H solid tumors

Monitor

monitor for immune-related adverse events

Use with caution and monitor for adverse effects.

✓

renal_impairment

mild moderate severe
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

no starting dose adjustment needed but monitor renal function

Monitor

monitor serum creatinine and renal function tests

✓

hepatic_impairment

mild moderate
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

no starting dose adjustment needed but monitor liver function

Monitor

monitor liver function tests including ALT AST bilirubin

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2014

Initial FDA approval for pembrolizumab

drug_classWHO
2023

Drug class

Value:PD-1 inhibitor (immunotherapy)

Pharmacological classification as immune checkpoint inhibitor

usageFDA
2023

Common uses

Value:Melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, Hodgkin lymphoma, gastric cancer, microsatellite instability-high cancers

Approved therapeutic indications

mechanismFDA
2023

Mechanism of action

Value:Blocks PD-1 receptor preventing tumor immune evasion

Pharmacodynamic mechanism

Used to treat melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, urothelial carcinoma (bladder cancer), head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer, and other solid tumors that express PD-L1 or have specific genetic characteristics.

Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor on T cells, blocking interaction with PD-L1 and PD-L2 ligands on tumor cells. This removes the brake on T cell activity, allowing immune cells to proliferate, produce cytokines, and attack cancer cells.

Administered as an IV infusion, typically every 3 or 6 weeks. Common side effects include fatigue, rash, diarrhea, and immune-related adverse events such as pneumonitis, colitis, and hepatitis. Requires monitoring for immune-mediated reactions and may need corticosteroids for management.

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