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Erbitux
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Basic Drug Information
Name: Erbitux
Active ingredient: cetuximab
Strength: 100 mg/50 mL and 200 mg/100 mL vial
Dosage: Intravenous (IV) infusion
Availability: Prescription only
Company: ImClone, Bristol-Myers Squibb and Merck
Approval date: February 2004
Erbitux is a prescription drug used for the treatment of certain cancers.
Erbitux belongs to a family of drugs called epidermal growth factor receptor (EGFR) inhibitors. Another member of this family is panitumumab (Vectibix).
Erbitux is co-marketed by ImClone, Bristol-Myers Squibb and Merck.
Uses
Erbitux is specifically indicated for treatment of the following conditions:
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- locally or regionally advanced squamous cell carcinoma of the head and neck (in combination with radiation therapy)
- recurrent or metastatic squamous cell carcinoma of the head and neck for whom platinum-based therapy has failed
Colorectal Cancer
- EGFR-expressing metastatic colorectal cancer after failure or intolerance of both irinotecan- and oxaliplatin-based regimens
- EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy (in combination with irinotecan)
How Erbitux is Taken
Squamous Cell Carcinoma of the Head and Neck
Erbitux in combination with radiation therapy:
- 400 mg/m^2 administered one week prior to initiation of a course of radiation therapy as a 120-minute intravenous infusion
- Subsequent weekly dose 250 mg/m^2 infused over 60 minutes for the duration of radiation therapy (6-7 weeks)
Erbitux by itself:
- 400 mg/m^2 administered as a 120-minute intravenous infusion
- Subsequent weekly dose 250 mg/m^2 infused over 60 minutes until disease progression or unacceptable toxicity
Colorectal Cancer
- 400 mg/m^2 administered as a 120-minute intravenous infusion
- Subsequent weekly dose 250 mg/m^2 infused over 60 minutes until disease progression or unacceptable toxicity
How Erbitux Works
Expression of a tyrosine kinase protein called epidermal growth factor receptor (EGFR) is detected in many human cancers including those of the head and neck, colon, and rectum.
Cetuximab binds specifically to the EGFR on tumor cells, thereby blocking epidermal growth factor (EGF) and other factors from binding and activating EGFR.
This blockade is believed to be the mechanism by which Erbitux prevents the growth of tumor cells.
How the Body Affects Erbitux
Peak circulating levels of cetuximab reach a steady-state by the third week of treatment.
Side Effects
The most common side effects (occurring in ≥25% of treated patients) are:
- skin reactions (including rash, itching, and nail changes)
- headache
- diarrhea
- infection
Risks and Precautions
- Infusion reactions may occur and may cause fevers, chills, or breathing problems.
- There are risks to use of this drug during pregnancy or nursing, so adequate contraception in both males and females during and for 6 months following, Erbitux therapy.
- Nursing is not recommended during, and for two months following, Erbitux therapy.
- Sun exposure is to be limited while receiving, and for 2 months following, Erbitux therapy.
Drug Interactions
A drug interaction study was performed in which Erbitux was administered in combination with irinotecan.
Effectiveness[1]
Squamous cell carcinoma of the head and neck (SCCHN)
A European trial, EXTREMEf, studied more than 400 patients treated with Erbitux in combination with either cisplatin- or carboplatin-based therapy compared with patients treated with platinum-based therapy alone.
Patients receiving Erbitux had a significantly higher response rate, an almost doubling of the time to tumor progression, and significantly longer survival.
Colorectal cancer (CRC)
The international CRYSTALa trial studied over 1,000 patients and demonstrated a significant increase of progression-free survival in the Erbitux/Folfiri group compared with the Folfiri alone group.
There was an overall 15% reduction in the risk of CRC growing or spreading. The study also showed that using Erbitux significantly increased response rate (increased tumor shrinkage by 50% or more).
References
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