Drug Class Description

Antineoplastic agents, monoclonal antibodies
Generic Name

Cetuximab
Drug Description

Each ml of solution for infusion contains 5 mg cetuximab. Each vial contains 10 ml, 20 ml, 50 ml or 100 ml.Cetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology
Presentation

Solution for infusion.Erbitux 5 mg/ml is a colourless solution.
Indications

Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer• in combination with chemotherapy• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck• in combination with radiation therapy for locally advanced disease• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease
Adult Dosage

Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion. Availability of resuscitation equipment must be ensured.

Prior to the first infusion, patients must receive premedication with an antihistamine and a corticosteroid. This premedication is recommended prior to all subsequent infusions.

In all indications, Erbitux is administered once a week. The very first dose is 400 mg cetuximab per m2 body surface area. All subsequent weekly doses are 250 mg/m2 each.

Colorectal cancer