It is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer: Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU. Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. Colorectal Cancer: As a single agent,EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens or in patients who are intolerant to irinotecan-based regimens. In combination with irinotecan,EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. Approval is based on objective response rate; no data are available demonstrating an improvement in increased survival.
Cetuximab is a recombinant human/mouse chimeric monoclonal antibody. It binds specifically to the epidermal growth factor receptor (EGFR), thus competitively inhibiting the binding of epidermal growth factor (EGF) and other ligands. This blocks phosphorylation and activation of receptor-associated kinases, thus inhibiting cell growth, inducing apoptosis and decreases matrix metalloproteinase and vascular EGF production.
Premedicate with an H1 antagonist. Administer 400 mg/m2 initial dose as a 120-minute intravenous infusion followed by 250 mg/m2 weekly infused over 60 minutes. Initiate Erbitux one week prior to initiation of radiation therapy. Complete Erbitux administration 1 hour prior to platinum-based therapy with 5-FU. Reduce the infusion rate by 50% for NCI CTC Grade 1 or 2 infusion reactions and non-serious NCI CTC Grade 3 infusion reaction. Permanently discontinue for serious infusion reactions. Withhold infusion for severe,persistent acneiform rash. Reduce dose for recurrent,severe rash.
No pharmacokinetic interaction was observed between cetuximab and irinotecan, cetuximab and cisplatin, and cetuximab
and carboplatin
Infusion Reactions,Cardiopulmonary Arrest ,Pulmonary Toxicity ,Dermatologic Toxicity ,Use of Erbitux in Combination With Radiation and Cisplatin ,Hypomagnesemia and Electrolyte Abnormalities ,Epidermal Growth Factor Receptor (EGFR) Expression and Response
Infusion Reactions: Immediately stop and permanently discontinue Erbitux for serious infusion reactions. Monitor patients following infusion. Cardiopulmonary Arrest: Closely monitor serum electrolytes during and after Erbitux. Pulmonary Toxicity: Interrupt therapy for acute onset or worsening of pulmonary symptoms. Dermatologic Toxicity: Limit sun exposure. Monitor for inflammatory or infectious sequelae. Hypomagnesemia: Periodically monitor during and for at least 8 weeks following the completion of Erbitux. Replete electrolytes as necessary.
Administer Erbitux to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
The maximum single dose of cetuximab administered is 1000 mg/m2 in one patient. No adverse events were reported for this patient.
Store vials under refrigeration at 2° to 8° C. Do not freeze.
.png&w=384&q=75)