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Cetuximab

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

Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), blocking signals that promote cancer cell growth and survival. It is primarily used to treat metastatic colorectal cancer and squamous cell carcinoma of the head and neck. By inhibiting EGFR, cetuximab can slow tumor progression and, in some cases, shrink tumors.

Quick summary

Cetuximab is a targeted cancer therapy monoclonal antibody that blocks EGFR to treat colorectal and head/neck cancers.

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

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
L01FE01
RxNorm
318341
Generic
Cetuximab
Class
atc-l01
Brands
Erbitux
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
400mg/m² initial dose followed by 250mg/m² weekly
Maximum
consult physician
Frequency
once weekly
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (limited_data)intravenous infusion
Usual dose
250-400mg/m² weekly (limited clinical data)
Maximum
consult physician
Frequency
once weekly
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)intravenous infusion
Usual dose
400mg/m² initial dose followed by 250mg/m² weekly
Maximum
consult physician
Frequency
once weekly
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 infusion reactions and dermatologic toxicity
Chronic overdose: cumulative dosing above recommended may lead to severe skin toxicity and electrolyte disturbances
Immediate actions
discontinue infusion, administer supportive care, monitor vital signs
Antidote
no specific antidote available(supportive care only, no specific antidote exists)
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 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

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

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

✗

lactation

breastfeeding
contraindicated
FDA Category
N
Dose Adjustment

discontinue breastfeeding

Key Recommendations

do not breastfeed during treatment and for at least 2 months after last dose

Monitor

not applicable

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

✗

pediatric_age

children under 18
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

not approved for use in pediatric patients; safety and efficacy not established

Monitor

not applicable

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

use with caution; monitor for adverse reactions including infusion reactions

Monitor

close monitoring for infusion reactions and skin toxicity

Use with caution and monitor for adverse effects.

⚠

renal_impairment

mild to moderate
caution
FDA Category
N
Dose Adjustment

no dose adjustment recommended

Key Recommendations

no specific dose adjustment required; monitor renal function

Monitor

regular monitoring of renal function

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild to moderate
caution
FDA Category
N
Dose Adjustment

no dose adjustment recommended

Key Recommendations

no specific dose adjustment for mild to moderate impairment; limited data for severe impairment

Monitor

monitor liver function tests

Use with caution and monitor for adverse effects.

⚠

alcohol_users

regular alcohol consumption
caution
FDA Category
N
Dose Adjustment

avoid or limit alcohol

Key Recommendations

avoid alcohol consumption during treatment as it may exacerbate skin reactions and dehydration

Monitor

monitor for worsening of skin toxicity and dehydration

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2004

FDA approval for Cetuximab

drug_classWHO
2023

Drug class

Value:Monoclonal antibody (EGFR inhibitor)

Drug class classification

usageMedical guidelines
2023

Common uses

Value:Metastatic colorectal cancer, head and neck squamous cell carcinoma

Therapeutic indications

Metastatic colorectal cancer (particularly in patients with KRAS wild-type tumors), squamous cell carcinoma of the head and neck (locally or regionally advanced and recurrent/metastatic disease), and locally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.

Cetuximab is a monoclonal antibody that binds specifically to the extracellular domain of the epidermal growth factor receptor (EGFR/HER1), blocking ligand binding and preventing receptor activation. This inhibition interferes with cancer cell proliferation, angiogenesis, and metastasis while promoting apoptosis.

Common side effects include acneiform skin rash (which correlates with treatment response), infusion reactions, hypomagnesemia, and electrolyte abnormalities. Cardiac arrhythmias and severe infusion reactions can occur. Requires pre-medication and careful monitoring during administration.

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