Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
cetuximab
Merck Europe B.V.
L01FE01
cetuximab
Antineoplastic agents
Head and Neck Neoplasms; Colorectal Neoplasms
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer:in combination with irinotecan-based chemotherapy;in first-line in combination with FOLFOX;as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.For details, see section 5.1.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.
Revision: 29
Authorised
2004-06-29
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE USER ERBITUX 5 MG/ML SOLUTION FOR INFUSION Cetuximab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor. − If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Erbitux is and what it is used for 2. What you need to know before you use Erbitux 3. How to use Erbitux 4. Possible side effects 5. How to store Erbitux 6. Contents of the pack and other information 1. WHAT ERBITUX IS AND WHAT IT IS USED FOR WHAT ERBITUX IS Erbitux contains cetuximab, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognise and bind to other unique proteins called antigens. Cetuximab binds to the epidermal growth factor receptor (EGFR), an antigen on the surface of certain cancer cells. EGFR activates proteins called RAS. RAS proteins play an important role in the EGFR pathway – a complex signalling cascade which is involved in the development and progression of cancer. As a result of this binding, the cancer cell can no longer receive the messages it needs for growth, progression and metastasis. WHAT ERBITUX IS USED FOR Erbitux is used to treat two different types of cancer: • metastatic cancer of the large intestine. In these patients, Erbitux is used alone or in combination with other anticancer medicines. • a certain type of cancer of the head and neck (squamous cell cancer). In these patients, Erbitux is used in combination with radiation therapy or with other anticancer medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ERBITUX DO NOT USE ERBITUX Do not use Erbitux if you have ever had a severe hypersensitivity (allergic) reaction to cetuximab. Before starting treatment for metastatic cancer of the large intestine your doctor will test your cancer Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 20 mL contains 100 mg cetuximab. Each vial of 100 mL contains 500 mg cetuximab. Cetuximab is a chimeric monoclonal IgG 1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology. For the 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, RAS wild-type metastatic colorectal cancer • in combination with irinotecan-based chemotherapy, • in first-line in combination with FOLFOX, • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. _For details, see section 5.1. _ 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 at least 1 hour prior to administration of cetuximab. 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 m 2 body surface area. All subsequent weekly doses are 250 mg cetuximab per m 2 each. 3 _Col Læs hele dokumentet