Erbitux Dosage/Direction for Use

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.
Colorectal cancer: As a single-agent or in combination with chemotherapy: 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 Precautions and Pharmacology: Pharmacodynamics under Actions).
Erbitux may be administered in a weekly or every other week dose regimen.
Weekly dose regimen: Erbitux 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.
Biweekly dose regimen: Erbitux is administered once every other week. Each dose is 500 mg cetuximab per m² body surface area.
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 hour after the end of the Erbitux infusion.
It is recommended that Erbitux treatment be continued until progression of the underlying disease.
In combination with encorafenib: Erbitux is administered once a week. The very first dose is 400 mg cetuximab per m² body surface area (BSA). All subsequent weekly doses are 250 mg/m² each.
Evidence of BRAF V600E mutation status is required before initiating treatment with Erbitux in combination with encorafenib. Mutational status should be determined by an experienced laboratory using validated test methods for detection BRAF V600E mutations.
For the dosage or recommended dose modifications of concomitantly used encorafenib, refer to the product information for these medicinal products. Encorafinib should be administered before starting cetuximab infusion.
It is recommended that Erbitux treatment be continued until progression of the underlying disease.
Squamous cell cancer of the head and neck: In combination with radiation therapy: In patients with locally advanced squamous cell cancer of the head and neck, Erbitux is used concomitantly with radiation therapy.
Erbitux 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.
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 combination with platinum-based chemotherapy: 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. Erbitux may be administered in a weekly or every other week dose regimen.
Weekly dose regimen: Erbitux 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.
Biweekly dose regimen: Erbitux is administered once every other week. Each dose is 500 mg cetuximab per m² body surface area.
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 Precautions).
Cetuximab has not been studied in patients with pre-existing haematological disorders (see Precautions).
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 Special precautions for disposal and other handling under Cautions for Usage).
The initial dose should be given slowly to minimize risk of infusion related reactions (see Precautions). The recommended infusion period is 120 minutes. For subsequent Erbitux administration, the infusion rate must not exceed 10 mg/min. If initial infusion is well tolerated, the recommended infusion period for weekly dose regimen of 250 mg/m² is 60 minutes and recommended infusion period for biweekly dose regimen of 500 mg/m² is 120 minutes.