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Nivolumab

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

Nivolumab is an immunotherapy medication that works by blocking the PD-1 receptor on T cells, helping restore the immune system's ability to recognize and attack cancer cells. It is used to treat various cancers including melanoma, non-small cell lung cancer, kidney cancer, and Hodgkin lymphoma.

Quick summary

Nivolumab is a PD-1 inhibitor immunotherapy drug used to treat multiple 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
L01FF01
RxNorm
1597876
Generic
Nivolumab
Class
atc-l01
Brands
Opdivo, Opdualag, Opdivo Qvantig
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
240mg every 2 weeks or 480mg every 4 weeks
Maximum
consult physician
Frequency
every 2 weeks or every 4 weeks
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)intravenous infusion
Usual dose
3 mg/kg every 2 weeks (max 240mg)
Maximum
consult physician
Frequency
every 2 weeks
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)intravenous infusion
Usual dose
240mg every 2 weeks or 480mg every 4 weeks
Maximum
consult physician
Frequency
every 2 weeks or every 4 weeks
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses above recommended may increase risk of severe immune-mediated adverse reactions
Chronic overdose: Cumulative doses exceeding recommended schedule may lead to sustained immune-related toxicities
Immediate actions
discontinue infusion, monitor vital signs, initiate corticosteroids
Antidote
corticosteroids (e.g., methylprednisolone)(primary treatment for immune-related adverse events)
Poison Control: 1-800-222-1222

Special Populations

9 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
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular fetal monitoring and ultrasound

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

✗

lactation

breastfeeding
unsafe
FDA Category
N
Dose Adjustment

discontinue breastfeeding

Key Recommendations

do not breastfeed during treatment and for at least 5 months after last dose

Monitor

none specified

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

monitor closely for adverse reactions as elderly may have higher incidence of severe adverse events

Monitor

regular monitoring of organ function and adverse effects

Use with caution and monitor for adverse effects.

⚠

pediatric_age

children 12 to 17 years
caution
FDA Category
N
Dose Adjustment

use weight-based dosing

Key Recommendations

approved for melanoma in patients 12 years and older monitor for immune-mediated adverse reactions

Monitor

close monitoring for immune-mediated adverse events

Use with caution and monitor for adverse effects.

✓

renal_impairment

mild moderate
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

no dose adjustment needed for mild to moderate renal impairment

Monitor

routine renal function monitoring

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

use with caution in severe renal impairment due to limited data

Monitor

close monitoring of renal function

Use with caution and monitor for adverse effects.

✓

hepatic_impairment

mild
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

no dose adjustment needed for mild hepatic impairment

Monitor

routine liver function monitoring

⚠

hepatic_impairment

moderate
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

use with caution in moderate hepatic impairment due to limited data

Monitor

close monitoring of liver function

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2014

First FDA approval for Nivolumab (Opdivo)

drug_classFDA
2023

Drug class

Value:PD-1 inhibitor; Monoclonal antibody; Immune checkpoint inhibitor

Classification as PD-1 blocking antibody

mechanismFDA
2023

Mechanism of action

Value:Programmed cell death protein 1 (PD-1) blockade

Primary pharmacologic mechanism

usageFDA
2023

Common indications

Value:Melanoma, Non-small cell lung cancer, Renal cell carcinoma, Squamous cell carcinoma of the head and neck, Urothelial carcinoma, Colorectal cancer, Hepatocellular carcinoma, Esophageal cancer, Gastric cancer

FDA-approved therapeutic indications

Treatment of various cancers including melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, and esophageal cancer.

Nivolumab is a monoclonal antibody that binds to the PD-1 receptor on T cells, blocking interaction with PD-L1 and PD-L2 ligands that tumors use to evade immune detection. This restores T-cell proliferation and cytokine production, enabling the immune system to attack cancer cells.

Administered as intravenous infusion. May cause immune-related adverse events affecting various organs including skin, liver, lungs, and endocrine system. Requires monitoring by healthcare providers experienced in immunotherapy. Safety and efficacy in pregnancy unknown; breastfeeding should be avoided.

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