Erbitux 5mg/ml

INFUSION, SOLUTION

**4.2 Posology and method of administration** 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. Resuscitation equipment must be available. Posology Prior to the first infusion, patients must receive premedication with an antihistamine and a corticosteroid at least 1 hour prior to administration of cetuximab. This premedication is recommended prior to all subsequent infusions. In all indications, Erbitux is administered once a week. The initial dose is 400 mg cetuximab per m2 body surface area. All subsequent weekly doses are 250 mg/m2 each. _Colorectal cancer_ In patients with metastatic colorectal cancer, Erbitux is used in combination with chemotherapy or as a single agent. Evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with Erbitux. Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4) mutations (see section 4.4 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, please refer to the product information for these medicinal products. They must not be administered earlier than 1 hour after the end of the Erbitux infusion. It is recommended that Erbitux 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, Erbitux is used concomitantly with radiation therapy. It is recommended to start Erbitux therapy one week before radiation therapy and to continue Erbitux therapy until the end of the radiation therapy period. In patients with recurrent and/or metastatic squamous cell cancer of the head and neck, Erbitux is used in combination with platinum-based chemotherapy followed by Erbitux as maintenance therapy until disease progression. Chemotherapy must not be administered earlier than 1 hour after the end of the Erbitux infusion. Special populations Only patients with adequate renal and hepatic function have been investigated to date (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Cetuximab has not been studied in patients with pre-existing haematological disorders (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No dose adjustment is required in older people, but the experience is limited in patients 75 years of age and above. _Paediatric population_ There is no relevant use of cetuximab in the paediatric population in the granted indications. Method of administration Erbitux 5 mg/ml is administered intravenously with an infusion pump, gravity drip or a syringe pump (for handling instructions, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The initial dose should be given slowly and speed of infusion must not exceed 5mg/min (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The recommended infusion period is 120 minutes. For the subsequent weekly doses, the recommended infusion period is 60 minutes. The infusion rate must not exceed 10 mg/min.