Recommended Topic Related To:

Erbitux

"The therascreen KRAS RGQ PCR Kit can provide information about the KRAS gene mutation in patients whose CRC has spread to other parts of their body (metastasized). Studies have found that Eribitux is not effective in those who have the mut"...

Erbitux

INDICATIONS

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Erbitux is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. [See Clinical Studies.]

Erbitux is indicated in combination with platinum-based therapy with 5-FU for the firstline treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck. [See Clinical Studies.]

Erbitux, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed. [See Clinical Studies.]

K-Ras Mutation-negative, EGFR-expressing Colorectal Cancer

Erbitux is indicated for the treatment of K-Ras mutation-negative (wild-type), epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, Clinical Studies]

Limitation of Use

Erbitux is not indicated for treatment of K-Ras mutation-positive colorectal cancer [see WARNINGS AND PRECAUTIONS, Clinical Studies].

DOSAGE AND ADMINISTRATION

Squamous Cell Carcinoma of the Head and Neck

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

  • The recommended initial dose is 400 mg/m² administered one week prior to initiation of a course of radiation therapy or on the day of initiation of platinumbased 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.
  • The 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
  • The recommended initial dose is 400 mg/m² administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min).
  • The 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

  • Determine K-Ras mutation and EGFR-expression status using FDA-approved tests prior to initiating treatment. Only patients whose tumors are K-Ras mutationnegative (wild-type) should receive Erbitux.
  • The recommended initial dose, 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.
  • The 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.

Recommended Premedication

Premedicate with an H1 antagonist (eg, 50 mg of diphenhydramine) intravenously 30-60 minutes prior to the first dose; premedication should be administered for subsequent Erbitux doses based upon clinical judgment and presence/severity of prior infusion reactions.

Dose Modifications

Infusion Reactions

Reduce the infusion rate by 50% for NCI CTC Grade 1 or 2 and non-serious NCI CTC Grade 3 infusion reaction.

Immediately and permanently discontinue Erbitux for serious infusion reactions, requiring medical intervention and/or hospitalization. [See WARNINGS AND PRECAUTIONS.]

Dermatologic Toxicity

Recommended dose modifications for severe (NCI CTC Grade 3 or 4) acneiform rash are specified in Table 1. [See WARNINGS AND PRECAUTIONS]

Table 1: Erbitux Dose Modification Guidelines for Rash

Severe Acneiform Rash Erbitux Outcome Erbitux Dose Modification
1st occurrence Delay infusion 1 to 2 weeks Improvement No Improvement Continue at 250 mg/m² Discontinue Erbitux
2nd occurrence Delay infusion 1 to 2 weeks Improvement No Improvement Reduce dose to 200 mg/m² Discontinue Erbitux
3rd occurrence Delay infusion 1 to 2 weeks Improvement No Improvement Reduce dose to 150 mg/m² Discontinue Erbitux
4th occurrence 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.

HOW SUPPLIED

Dosage Forms And Strengths

100 mg/50 mL, single-use vial

200 mg/100 mL, single-use vial

Storage And Handling

Erbitux® (cetuximab) is supplied at a concentration of 2 mg/mL as a 100 mg/50 mL, single-use vial or as a 200 mg/100 mL, single-use vial as a sterile, injectable liquid containing no preservatives.

NDC 66733-948-23 100 mg/50 mL, single-use vial, individually packaged in a carton

NDC 66733-958-23 200 mg/100 mL, single-use vial, individually packaged in a carton

Store vials under refrigeration at 2° C to 8° C (36° F to 46° F). Do not freeze. Increased particulate formation may occur at temperatures at or below 0° C. This product contains no preservatives. Preparations of Erbitux in infusion containers are chemically and physically stable for up to 12 hours at 2° C to 8° C (36° F to 46° F) and up to 8 hours at controlled room temperature (20° C to 25° C; 68° F to 77° F). Discard any remaining solution in the infusion container after 8 hours at controlled room temperature or after 12 hours at 2° C to 8° C. Discard any unused portion of the vial.

Manufactured by ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. Distributed and marketed by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA, Co-marketed by Eli Lilly and Company, Indianapolis, IN 46285 USA. Rev March 2013

Last reviewed on RxList: 3/25/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Erbitux - User Reviews

Erbitux User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Erbitux sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cancer

Get the latest treatment options.