mmended that women do not breast-feed during treatment with Erbitux and for 2 months after the last dose, because it is not known whether cetuximab is excreted in breast milk.
Fertility
There are no data on the effect of cetuximab on human fertility. Effects on male and female fertility have not been eva luated within formal animal studies (see section 5.3).
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. If patients experience treatment-related symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
4.8 Undesirable effects
The main undesirable effects of cetuximab are skin reactions, which occur in more than 80% of patients, hypomagnesaemia which occurs in more than 10% of patients and infusion-related reactions, which occur with mild to moderate symptoms in more than 10% of patients and with severe symptoms in more than 1% of patients.
The following definitions apply to the frequency terminology used hereafter:
Very common ( 1/10)
Common ( 1/100 to < 1/10)
Uncommon ( 1/1,000 to < 1/100)
Rare ( 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Frequency not known (cannot be estimated from the available data)
An asterisk (*) indicates that additional information on the respective undesirable effect is provided below the table.
Metabolism and nutrition disorders
|
Very common:
|
Hypomagnesaemia (see section 4.4).
|
|
Common:
|
Dehydration, in particular secondary to diarrhoea or mucositis; hypocalcaemia (see section 4.4); anorexia which may lead to weight decrease.
|
|
Nervous system disorders
|
|
Common:
|
Headache.
|
|
Frequency not known:
|
Aseptic meningitis.
|
|
Eye disorders
|
|
Common:
|
Conjunctivitis.
|
|
Uncommon:
|
Blepharitis, keratitis.
|
|
Vascular disorders
|
|
Uncommon:
|
Deep vein thrombosis.
|
|
Respiratory, thoracic and mediastinal disorders
|
|
Uncommon:
|
Pulmonary embolism, interstitial lung disease.
|
|
Gastrointestinal disorders
|
|
Common:
|
Diarrhoea, nausea, vomiting.
|
|
Hepatobiliary disorders
|
|
Very common:
|
Increase in liver enzyme levels (ASAT, ALAT, AP).
|
|
Skin and subcutaneous tissue disorders
|
|
Very common:
|
Skin reactions*.
|
|
Very rare:
|
Stevens-Johnson syndrome/toxic epidermal necrolysis.
|
|
Frequency not known:
|
Superinfection of skin lesions*.
|
