For doctors
What is it and how is it used?
What Erbitux is

Erbitux contains cetuximab, a monoclonal antibody. Monoclonal antibodies are proteins thatspecifically recognise and bind to other unique proteins called antigens. Cetuximab binds to theepidermal growth factor receptor (EGFR), an antigen on the surface of certain cancer cells. As a resultof this binding, the cancer cell can no longer receive the messages it needs for growth, progression andmetastasis.

What Erbitux is used for

Erbitux is used to treat two different types of cancer:

What do you have to consider before using it?
Do not use Erbitux
Do not use Erbitux if you have ever had a severe hypersensitivity (allergic) reaction to cetuximab.

Take special care with Erbitux
Erbitux may cause infusion-related side effects. Such reactions may be allergic in nature. Please read'Infusion-related side effects' in section 4 for details, as they may have serious consequences for you,including life-threatening conditions. These side effects normally occur during the infusion, within1 hour afterwards, or sometimes also after this period. To recognise early signs of such effects, yourcondition will be checked regularly while you receive each infusion of Erbitux and for at least 1 hourafterwards.

If you receive Erbitux in combination with anticancer medicines including platinum, it is more likelythat your white blood cell count may be reduced. Your doctor will therefore monitor your blood andgeneral condition for signs of infection (see also 'Side effects in combination with other anticancertreatments' in section 4).

If you receive Erbitux in combination with other anticancer medicines, including fluoropyrimidines,it may be more likely that you experience heart problems which may be life-threatening. Your doctorwill discuss with you whether you may need any particular supervision (see also 'Side effects incombination with other anticancer treatments' in section 4).

Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, includingmedicines obtained without a prescription.

Pregnancy
Tell your doctor if you are pregnant or if you are not using reliable contraception (speak to your doctorif you are not sure). Your doctor will then discuss with you the risks and benefits of using Erbitux inthese situations.

Breast-feeding
Do not breast-feed your baby during the period over which you are being treated with Erbitux and fortwo months after the last dose.

Driving and using machines
Do not drive or use any tools or machines if you experience treatment-related symptoms that affectyour ability to concentrate and react.

How is it used?
A doctor experienced in the use of anticancer medicines will supervise your Erbitux therapy. Duringeach infusion and for at least 1 hour afterwards, your condition will be checked regularly for earlysigns of a possible infusion-related side effect.

Pre-treatment

Before the first dose, you will receive an antiallergic medicine in order to reduce the risk of an allergicreaction. Your doctor will decide whether such pre-treatment is necessary for subsequent doses.

Dosage and administration

Erbitux is usually infused into a vein (given as a drip) once a week. Your doctor will calculate thecorrect dose of Erbitux for you because it depends on your body surface area. The first dose (400 mg/m² body surfa