Erbitux Dosage

Generic name: cetuximab 2mg in 1mL
Dosage form: injection, solution
Drug class: EGFR inhibitors

Medically reviewed by Drugs.com. Last updated on Jul 25, 2024.

Patient Selection

Select patients with metastatic colorectal cancer (CRC) for treatment with ERBITUX based on the presence of:

Ras wild-type, EGFR-expressing CRC, or
BRAF V600E mutation-positive metastatic CRC

Information on FDA-approved tests for the detection of K-Ras or BRAF V600E mutations in CRC in patients with metastatic CRC is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage for Squamous Cell Carcinoma of the Head and Neck (SCCHN)

In combination with radiation therapy

Initial dose: 400 mg/m2 administered as a 120-minute intravenous infusion one week prior to initiating a course of radiation therapy.
Subsequent doses: 250 mg/m2 administered as a 60-minute infusion every week for the duration of radiation therapy (6–7 weeks).
Complete ERBITUX administration 1 hour prior to radiation therapy.

As a single-agent or in combination with platinum-based therapy and fluorouracil

Administer Erbitux as a single-agent or in combination with platinum-based therapy and fluorouracil on a weekly or biweekly schedule.

Weekly Dosage

Initial dose: 400 mg/m2 administered as a 120-minute intravenous infusion
Subsequent doses: 250 mg/m2 administered as a 60-minute infusion every week

Biweekly Dosage

Initial and subsequent doses: 500 mg/m2 administered as a 120-minute intravenous infusion every 2 weeks

Complete ERBITUX administration 1 hour prior to platinum-based therapy with fluorouracil. Continue treatment until disease progression or unacceptable toxicity.

Recommended Dosage for Colorectal Cancer (CRC)

As a single-agent or in combination with irinotecan or FOLFIRI (irinotecan, fluorouracil, leucovorin)

Administer Erbitux as a single-agent or in combination with irinotecan or FOLFIRI (irinotecan, fluorouracil, leucovorin) on a weekly or biweekly schedule.

Weekly Dosage

Initial dose: 400 mg/m2 administered as a 120-minute intravenous infusion
Subsequent doses: 250 mg/m2 administered as a 60-minute infusion every week

Biweekly Dosage

Initial and subsequent doses: 500 mg/m2 administered as a 120-minute intravenous infusion every 2 weeks

Complete ERBITUX administration 1 hour prior to irinotecan or FOLFIRI. Continue treatment until disease progression or unacceptable toxicity.

In combination with encorafenib

The recommended initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion in combination with encorafenib.
The recommended subsequent dosage is 250 mg/m2 weekly as a 60-minute infusion in combination with encorafenib until disease progression or unacceptable toxicity.

Refer to the encorafenib prescribing information for recommended encorafenib dosage information.

Premedication

Premedicate with a histamine-1 (H1) receptor antagonist intravenously 30–60 minutes prior to the first dose or subsequent doses as deemed necessary.

Dosage Modifications for Adverse Reactions

Reduce, delay, or discontinue ERBITUX to manage adverse reactions as described in Table 1.

Table 1: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction	Severitya	Dosage Modification
a National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.
Infusion reactions	Grade 1 or 2	Reduce the infusion rate by 50%.
Infusion reactions	Grade 3 or 4	Immediately and permanently, discontinue ERBITUX.
Dermatologic toxicities and infectious sequelae (e.g., acneiform rash, mucocutaneous disease)	1st occurrence; Grade 3 or 4	Delay infusion 1 to 2 weeks; if condition improves, continue at 250 mg/m2. If no improvement, discontinue ERBITUX.
	2nd occurrence; Grade 3 or 4	Delay infusion 1 to 2 weeks; if condition improves, continue at 200 mg/m2. If no improvement, discontinue ERBITUX.
	3rd occurrence; Grade 3 or 4	Delay infusion 1 to 2 weeks; if condition improves, continue at 150 mg/m2. If no improvement, discontinue ERBITUX.
	4th occurrence; Grade 3 or 4	Discontinue ERBITUX.
Pulmonary toxicity	Acute onset or worsening pulmonary symptoms	Delay infusion 1 to 2 weeks; if condition improves, continue at the dose that was being administered at the time of occurrence. If no improvement in 2 weeks or interstitial lung disease (ILD) is confirmed, discontinue ERBITUX.

Preparation for Administration

The solution should be clear and colorless and may contain a small amount of easily visible, white, amorphous, cetuximab particulates. Do not shake or dilute.
Visually inspect for foreign particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if solution is discolored, cloudy, or contains foreign particulate matter.
Do not administer ERBITUX as an intravenous push or bolus.
Administer via infusion pump or syringe pump. Do not exceed an infusion rate of 10 mg/min.
Administer through a low protein binding 0.22-micrometer in-line filter.