Active Ingredient: Cetuximab
Cetuximab 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 400 milligrams cetuximab per square meter of body surface, one dose, over the duration of 1 week. Afterwards, intravenous, 250 milligrams cetuximab per square meter of body surface, once weekly.
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 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.
Cetuximab is administered once a week. The initial dose is 400 mg cetuximab per m² body surface area (BSA). All subsequent weekly doses are 250 mg/m² each.
No dose adjustment is required in older people, but the experience is limited in patients 75 years of age and above.
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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