If you receive Erbitux in combination with an anticancer medicine containing fluoropyrimidines, it ismore likely that you experience the following side effects of this other medicine:

If you receive Erbitux with radiation therapy, some of the side effects you may experience can also berelated to this combination, such as:

How should it be stored?
Keep out of the reach and sight of children.

Do not use Erbitux after the expiry date which is stated on the label and the carton after EXP. Theexpiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

Once opened, Erbitux is intended for immediate use.

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For doctors
What is it?
Erbitux is a solution for infusion (drip into a vein) that contains the active substance cetuximab.

What is it used for?
Erbitux is used to treat the following types of cancer:

How is it used?
Erbitux should only be given by doctors who have experience in the use of anticancer medicines. Before receiving Erbitux for the first time, the patient must be given an antihistamine and a corticosteroid to prevent an allergic reaction. This is also recommended for all subsequent infusions. Erbitux is given once a week. The first infusion is given at a dose of 400 mg per square metre body surface area (calculated using the patient’s height and weight) over two hours. The following infusions are 250 mg/m given over one hour. When it is used on its own or with other anticancer medicines, Erbitux is continued for as long as the patient responds. When it is used with radiotherapy, Erbitux is started one week before the radiotherapy starts and continued until the radiotherapy has finished.

How does it work?
The active substance in Erbitux, cetuximab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure

(called an antigen) in the body. Cetuximab has been designed to attach to EGFR, which can be found on the surface of some tumour cells. As a result, the tumour cells can no longer receive the messages needed for growth, progression and spread. Between 79 and 89% of colorectal cancers and more than 90% of squamous cell cancers of the head and neck have EGFR on their cell surfaces.

How has it been studied?
For metastatic cancer of the colon or rectum, Erbitux was studied in five main studies:

What benefits has it shown during the studies?
In the studies of cancer of the colon or rectum, the patients who had wild-type KRAS in their tumours lived for longer without their disease getting worse when they received Erbitux:

What is the risk associated?
The most common side effects with Erbitux (seen in more than 1 patient in 10) are skin reactions such as rash, hypomagnesaemia (low blood magnesium levels), reactions linked to the infusion (such as fever, chills, dizziness and difficulty breathing), mucositis (inflammation of the lining of the mouth) and raised levels of some liver enzymes. Skin reactions are seen in more than 80% of patients. For the full list of all side effects reported with Erbitux, see the Package Leaflet.
Erbitux should not be used in people who are very hypersensitive (allergic) to cetuximab. Erbi