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Tremelimumab

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

Tremelimumab-actl is an immunotherapy medication classified as a CTLA-4 inhibitor monoclonal antibody. It works by blocking the CTLA-4 protein on T-cells, which normally acts as a brake on immune responses, thereby enhancing the body's ability to recognize and attack cancer cells. This drug is used to treat certain cancers, particularly in combination with other immunotherapies.

Quick summary

Tremelimumab is a monoclonal antibody that blocks CTLA-4 to unleash immune system activity against cancer cells.

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

Key facts at a glance

ATC
L01FX20
RxNorm
2619313
Generic
Tremelimumab
Class
atc-l01
Brands
Imjudo
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 therapeutic dose that may cause serious toxicity
Chronic overdose: cumulative doses exceeding recommended treatment regimen leading to increased immune-mediated toxicity
Immediate actions
discontinue drug infusion, monitor vital signs, provide supportive care, evaluate for immune-mediated toxicity
Antidote
No specific antidote available(Supportive care and immunosuppressants such as corticosteroids are used to manage overdose effects)
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
unsafe
FDA Category
C
Dose Adjustment

avoid

Key Recommendations

discontinue therapy if pregnancy occurs during treatment

Monitor

fetal ultrasound monitoring

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 3 months after last dose

Monitor

not applicable

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

?

pediatric_age

children adolescents
unknown
FDA Category
N
Dose Adjustment

not established

Key Recommendations

safety and efficacy not established in pediatric patients

Monitor

not applicable

⚠

geriatric

elderly 65 years
caution
FDA Category
N
Dose Adjustment

no specific adjustment

Key Recommendations

use with caution due to potential increased adverse events

Monitor

close monitoring for immune-related adverse events

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe renal impairment
caution
FDA Category
N
Dose Adjustment

monitor closely

Key Recommendations

use with caution; no formal dosing recommendations for severe impairment

Monitor

monitor renal function regularly

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate severe hepatic
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

no dose modification recommended but monitor hepatic function closely

Monitor

regular liver function tests

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classFDA
2023

Drug class

Value:CTLA-4 inhibitor; Monoclonal antibody

Drug class classification for Tremelimumab (Imjudo)

prescribingFDA
2023

FDA approval year

Value:2022

FDA approval year for Imjudo (tremelimumab)

usageFDA
2023

Common uses

Value:Unresectable hepatocellular carcinoma, unresectable or metastatic melanoma, non-small cell lung cancer

Approved therapeutic indications for Tremelimumab

Tremelimumab is primarily indicated for the treatment of unresectable hepatocellular carcinoma (a type of liver cancer) and metastatic non-small cell lung cancer. It is typically administered in combination with durvalumab (another immunotherapy drug) in patients who meet specific clinical criteria.

Tremelimumab-actl is a monoclonal antibody that binds specifically to the CTLA-4 receptor on T-cells. By blocking CTLA-4, it prevents the protein from interacting with its ligands CD80 and CD86, thereby removing the inhibitory signal that normally suppresses T-cell activation and proliferation. This allows T-cells to become more active and effective at targeting and destroying cancer cells.

As an immunotherapy agent, tremelimumab can cause immune-related adverse events including colitis, hepatitis, pneumonitis, and endocrinopathies. Patients should be monitored closely for signs of autoimmune reactions. Pre-infusion medications may be required to manage potential infusion reactions. Treatment should only be administered by healthcare professionals experienced in cancer 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