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 surface area) is infused over a period of approximately 2 hours. Each subsequent dose(250 mg/m²) is infused in approximately 1 hour. Erbitux must not be infused more rapidly than 10 mg/min.
Detailed instructions for your doctor or your nurse on how to prepare the Erbitux infusion are includedat the end of this package leaflet (see 'Handling instructions').
Duration of treatment
Erbitux is usually infused once a week. The duration of treatment may vary depending on your diseaseas well as from person to person and your doctor will therefore discuss with you how long you willreceive Erbitux.
Combination with other anticancer treatments
If you receive Erbitux in combination with other anticancer medicines, these medicines must beadministered at least 1 hour after the end of the Erbitux infusion.
If you receive Erbitux in combination with radiation therapy, treatment with Erbitux is usually startedone week before radiation therapy.
What are possible side effects?
Like all medicines, Erbitux can cause side effects, although not everybody gets them.
The main side effects of Erbitux are infusion-related side effects and side effects concerning the skin:
Infusion-related side effects
More than 10 out of 100 patients are likely to experience infusion-related side effects; in more than 1out of 100 patients these side effects are likely to be severe. Such reactions may be allergic in nature.They normally occur during the infusion, within 1 hour afterwards, or sometimes also after this period.
Mild or moderate infusion-related side effects include:
Severe infusion-related side effects include:
Side effects concerning the skin
More than 80 out of 100 patients are likely to experience side effects involving the skin. In about15 out of 100 patients these skin reactions are likely to be severe. Most of these side effects developwithin the first three weeks of treatment. They usually disappear over time after the end of Erbituxtherapy.
Main side effects concerning the skin include:
If you notice extensive skin alterations, please inform your doctor as soon as possible because theErbitux dose or the time between infusions may need to be changed. Your doctor will decide whethertreatment has to be stopped if skin reactions reappear after several dose reductions.
If you notice that already affected areas of your skin get worse, speak to a doctor immediately,especially if you also experience general signs of infection such as fever and tiredness. These signsmay indicate a skin infection, which may have serious consequences including life-threateningconditions.
Other side effects
Very common side effects (may affect more than 1 user in 10)
Common side effects (may affect 1 to 10 users in 100)
Uncommon side effects (may affect 1 to 10 users in 1,000)
Side effects of which the frequency is not known
Side effects in combination with other anticancer treatments
If you receive Erbitux in combination with other anticancer medicines, some of the side effects youmay experience can also be related to the combination or the other medicines. Therefore, please makesure that you also read the package leaflet for the other medicines.
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likelythat your white blood cell count may be reduced. This may lead to infectious complications includinglife-threatening conditions, especially if you experience skin reactions, inflammation of the lining ofthe intestine and mouth or diarrhoea. Therefore, if you experience general signs of infection such asfever and tiredness, please speak to a doctor immediately.
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). Do not freeze.
Once opened, Erbitux is intended for immediate use.
