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Erbitux Dosage

Generic name: cetuximab 2mg in 1mL
Dosage form: injection, solution

Medically reviewed on June 5, 2018.

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

In combination with radiation therapy or platinum-based therapy and fluorouracil

  • The recommended initial dose is 400 mg/m2 administered one week prior to initiating a course of radiation therapy or on the first day of platinum-based therapy and fluorouracil as a 120-minute intravenous infusion.
  • The recommended subsequent dosage (all other infusions) is 250 mg/m2 weekly as a 60-minute infusion for the duration of radiation therapy (6–7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy and fluorouracil.
  • Complete ERBITUX administration 1 hour prior to radiation therapy or platinum-based therapy with fluorouracil.

Monotherapy

  • The recommended initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion.
  • The recommended subsequent dosage (all other infusions) is 250 mg/m2 weekly as a 60-minute infusion until disease progression or unacceptable toxicity.

Recommended Dosage for Colorectal Cancer (CRC)

Determine EGFR-expression status using FDA-approved tests prior to initiating treatment. Also confirm the absence of a Ras mutation prior to initiation of treatment with ERBITUX. Information on FDA-approved tests for the detection of K-Ras mutations in patients with metastatic CRC is available at: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm.

  • The recommended initial dose, either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, fluorouracil, leucovorin), is 400 mg/m2 administered as a 120-minute intravenous infusion.
  • The recommended subsequent dosage, either as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m2 weekly as a 60-minute infusion until disease progression or unacceptable toxicity.
  • Complete ERBITUX administration 1 hour prior to irinotecan or FOLFIRI.

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

  • 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.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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