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 hr after the end of the infusion. Availability of resuscitation equipment must be ensured.
Prior to the 1st 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 1st dose is cetuximab 400 mg/m2 body surface area. All subsequent weekly doses are 250 mg/m2 each.
Colorectal Cancer: In patients with metastatic colorectal cancer, cetuximab is used in combination with chemotherapy or as a single agent (see Pharmacology under Actions). Detection of KRAS mutational status must be performed prior to the 1st cetuximab infusion. It is important that a validated test method is used by an experienced laboratory (see Pharmacology under Actions and Precautions).
For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these medicinal products. They must not be administered earlier than 1 hr after the end of the cetuximab infusion.
It is recommended that cetuximab treatment be continued until progression of the underlying disease.
Squamous Cell Cancer of the Head and Neck: In patients with locally advanced squamous cell cancer of the head and neck, cetuximab is used concomitantly with radiation therapy. It is recommended to start cetuximab therapy 1 week before radiation therapy and to continue cetuximab therapy until the end of the radiation therapy period.
In patients with recurrent and/or metastatic squamous cell cancer of the head and neck, cetuximab is used in combination with platinum-based chemotherapy followed by cetuximab as maintenance therapy until disease progression (see Pharmacology under Actions). Chemotherapy must not be administered earlier than 1 hr after the end of the cetuximab infusion.
Special Populations: Only patients with adequate renal and hepatic function have been investigated to date (see Precautions).
Cetuximab has not been studied in patients with preexisting haematological disorders (see Precautions).
No dose adjustment is required in the elderly, but the experience is limited in patients ≥75 years.
Paediatric Population: There is no experience in children (see Precautions).
Administration: Erbitux 5 mg/mL is administered IV with an infusion pump, gravity drip or a syringe pump (for handling instructions, see Cautions For Usage).
For the initial dose, the recommended infusion period is 120 min.
For the subsequent weekly doses, the recommended infusion period is 60 min. The maximum infusion rate must not exceed 10 mg/min.