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 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 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 (see section 5.1). Chemotherapy must not be administered earlier than 1 hour after the end of the cetuximab infusion.

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).

For the initial dose, the recommended infusion period is 120 minutes. For the subsequent weekly doses, the recommended infusion period is 60 minutes. The maximum infusion rate must not exceed 10 mg/min.

Special populations

Only patients with adequate renal and hepatic function have been investigated to date (see section 4.4).

Cetuximab has not been studied in patients with pre-existing haematological disorders (see section 4.4).

No dose adjustment is required in the elderly, but the experience is limited in patients 75 years of age and above.

Paediatric population

The efficacy of cetuximab in paediatric patients below the age of 18 years has not been established. No new safety signals were identified in paediatric patients as reported from a phase-I study.

4.3 Contraindications

 Erbitux is contraindicated in patients with known severe (grade 3 or 4) hypersensitivity reactions to cetuximab.

Before initiation of combination treatment, contraindications for concomitantly used chemotherapeutic agents or radiation therapy must be considered.

4.4 Special warnings and precautions for use

 Infusion-related reactions

If the patient experiences a mild or moderate infusion-related reaction, the infusion rate may be decreased. It is recommended to maintain this lower infusion rate in all subsequent infusions.

Severe infusion-related reactions have been reported in patients treated with cetuximab (see section 4.8). Symptoms usually occurred during the first infusion and up to 1 hour after the end of infusion, but may occur after several hours or with subsequent infusions. It is recommended to warn patients of the possibility of such a late onset and instruct them to contact their physician if symptoms of an infusion-related reaction occur. Occurrence of a severe infusion-related reaction requires immediate and permanent discontinuation of cetuximab therapy and may necessitate emergency treatment.

Special attention is recommended for patients with reduced performance status and pre-existing cardio-pulmonary disease.

Respiratory disorders