Cetuximab

Cetuximab
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Black Box Warning

WARNING: SERIOUS INFUSION REACTIONS and CARDIOPULMONARY ARREST See full prescribing information for complete Boxed Warning. * Serious infusion reactions, some fatal, occurred in approximately 3% of patients. (5.1) Cardiopulmonary arrest and/or sudden death occurred in 2% of patients with squamous cell carcinoma of the head and neck treated with Erbitux and radiation therapy and in 3% of patients with squamous cell carcinoma of the head and neck treated with cetuximab in combination with platinum-based therapy with 5-fluorouracil (5-FU). Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after Erbitux administration. (5.2, 5.6)

Overview

Cetuximab is a Monoclonal Antibody that is FDA approved for the {{{indicationType}}} of Squamous Cell Carcinoma of the Head and Neck (SCCHN), K-Ras Mutation-negative, EGFR-expressing Colorectal Cancer. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Acneiform eruption, Dry skin, Pruritus, Radiation dermatitis, Rash, Hypomagnesemia, Weight decreasing, Constipation, Diarrhea, Nausea, Neutropenia, Infectious disease, Asthenia, Headache, Sensory neuropathy, Dyspnea, Fatigue, Late effect of radiation, Pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Squamous Cell Carcinoma of the Head and Neck

• Dosing information

• Erbitux in combination with radiation therapy or in combination with platinum-based therapy with 5-FU:

• Recommended initial dosage: 400 mg/m2 administered one week prior to initiation of a course of radiation therapy or on the day of initiation of platinum-based therapy with 5-FU as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Erbitux administration 1 hour prior to platinum-based therapy with 5-FU.
• Recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) for the duration of radiation therapy (6–7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy with 5-FU.
• Complete Erbitux administration 1 hour prior to radiation therapy or platinum-based therapy with 5-FU.

• Erbitux monotherapy:

• Recommended initial dosage:400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min).
• Recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity.

Colorectal Cancer

• Dosing information

• Determine K-Ras mutation and EGFR-expression status using FDA-approved tests prior to initiating treatment. Only patients whose tumors are K-Ras mutation-negative (wild-type) should receive Erbitux.
• Recommended initial dosage: either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Erbitux administration 1 hour prior to FOLFIRI.
• Recommended subsequent weekly dose, either as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Complete Erbitux administration 1 hour prior to FOLFIRI.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cetuximab in adult patients.

Non–Guideline-Supported Use

Gastric cancer

• Dosing information

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Cetuximab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cetuximab in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cetuximab in pediatric patients.

Contraindications

There is limited information regarding Cetuximab Contraindications in the drug label.

Warnings

WARNING: SERIOUS INFUSION REACTIONS and CARDIOPULMONARY ARREST See full prescribing information for complete Boxed Warning. * Serious infusion reactions, some fatal, occurred in approximately 3% of patients. (5.1) Cardiopulmonary arrest and/or sudden death occurred in 2% of patients with squamous cell carcinoma of the head and neck treated with Erbitux and radiation therapy and in 3% of patients with squamous cell carcinoma of the head and neck treated with cetuximab in combination with platinum-based therapy with 5-fluorouracil (5-FU). Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after Erbitux administration. (5.2, 5.6)

There is limited information regarding Cetuximab Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Cetuximab Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Cetuximab Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Cetuximab Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Cetuximab in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cetuximab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cetuximab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cetuximab in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Cetuximab in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Cetuximab in geriatric settings.

Gender

There is no FDA guidance on the use of Cetuximab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cetuximab with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cetuximab in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cetuximab in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cetuximab in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cetuximab in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Cetuximab Administration in the drug label.

Monitoring

There is limited information regarding Cetuximab Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Cetuximab and IV administrations.

Overdosage

There is limited information regarding Cetuximab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Cetuximab Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Cetuximab Mechanism of Action in the drug label.

Structure

There is limited information regarding Cetuximab Structure in the drug label.

Pharmacodynamics

There is limited information regarding Cetuximab Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Cetuximab Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Cetuximab Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Cetuximab Clinical Studies in the drug label.

How Supplied

There is limited information regarding Cetuximab How Supplied in the drug label.

Storage

There is limited information regarding Cetuximab Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Cetuximab Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Cetuximab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Cetuximab Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Cetuximab Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.