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Erbitux Dosage

Drug Detail:Erbitux (Cetuximab [ se-tux-i-mab ])

Generic Name: cetuximab 2mg in 1mL

Dosage Form: injection, solution

Drug Class: EGFR inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Patient Selection

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

  • Ras wild-type, EGFR-expressing CRC [see Clinical Studies (14.2)], or
  • BRAF V600E mutation-positive metastatic CRC [see Clinical Studies (14.3)]

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 [see Warnings and Precautions (5.1)].

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 [see Warnings and Precautions (5.1)] Grade 1 or 2 Reduce the infusion rate by 50%.
Grade 3 or 4 Immediately and permanently, discontinue ERBITUX.
Dermatologic toxicities and infectious sequelae (e.g., acneiform rash, mucocutaneous disease) [see Warnings and Precautions (5.4)] 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 [see Warnings and Precautions (5.3)] 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.
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