Active Ingredient: Cetuximab
Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck:
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
250 - 400 mg per m² of body surface area (BSA)
From 250 To 400 mg per m² of body surface area (BSA) once every 7 day(s)
400 mg per m² of body surface area (BSA)
250 mg per m² of body surface area (BSA)
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, cetuximab is administered once a week. The initial dose is 400 mg cetuximab per m² body surface area. All subsequent weekly doses are 250 mg cetuximab per m² each.
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 one 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. Chemotherapy must not be administered earlier than 1 hour after the end of the cetuximab infusion.
The initial dose should be given slowly and speed of infusion must not exceed 5 mg/min. 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.
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