Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
1. NAME OF THE MEDICINAL PRODUCT
 Erbitux 5 mg/ml solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each ml of solution for infusion contains 5 mg cetuximab.

Each vial of 10 ml contains 50 mg cetuximab.

Each vial of 20 ml contains 100 mg cetuximab.

Each vial of 50 ml contains 250 mg cetuximab.

Each vial of 100 ml contains 500 mg cetuximab.

Cetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

 Solution for infusion.

Colourless solution.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer

• in combination with irinotecan-based chemotherapy or FOLFOX4 (for details, see section 5.1),

• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck

• in combination with radiation therapy for locally advanced disease,

• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

4.2 Posology and method of administration

 Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion. Availability of resuscitation equipment must be ensured.

Posology

Prior to the first infusion, patients must receive premedication with an antihistamine and a corticosteroid. This premedication is recommended prior to all subsequent infusions.

In all indications, Erbitux is administered once a week. The initial dose is 400 mg cetuximab per m2 body surface area. All subsequent weekly doses are 250 mg cetuximab per m2 each.

Colorectal cancer

In patients with metastatic colorectal cancer, cetuximab is used in combination with chemotherapy or as a single agent (see section 5.1). Detection of KRAS mutational status must be performed prior to the first cetuximab infusion.