Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
alemtuzumab
Genzyme Europe B.V.
L01XC04
alemtuzumab
Antineoplastic agents
Leukemia, Lymphocytic, Chronic, B-Cell
MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.
Revision: 14
Withdrawn
2001-07-06
47 B. PACKAGE LEAFLET Medicinal product no longer authorised 48 PACKAGE LEAFLET: INFORMATION FOR THE USER MABCAMPATH 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Alemtuzumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What MabCampath is and what it is used for 2. Before you use MabCampath 3. How to use MabCampath 4. Possible side effects 5. How to store MabCampath 6. Further information 1. WHAT MABCAMPATH IS AND WHAT IT IS USED FOR MabCampath is used to treat patients with chronic lymphocytic leukaemia (CLL), a cancer of the lymphocytes (a type of white blood cell). It is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate. The active substance in MabCampath, alemtuzumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body. In CLL, too many lymphocytes are produced. Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with sugar molecules) that is found on the surface of lymphocytes. As a result of this binding, the lymphocytes die, and this helps to control the CLL. 2. BEFORE YOU USE MABCAMPATH DO NOT USE MABCAMPATH IF YOU: are allergic to alemtuzumab or to proteins of a similar origin or to any of the other ingredients of MabCampath (see section 6 “Further Information”). Your doctor will inform you accordingly have an infection have HIV have an active second malignancy are pregnant (see also “Pregnancy”). TAKE SPECIAL CARE WITH MABCAMPATH: When you FIRST RECEIVE MabCampath, you may experience side effects Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT MabCampath 10 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains 10 mg of alemtuzumab. Each ampoule contains 30 mg of alemtuzumab. Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52). The antibody is produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Colourless to slightly yellow concentrate. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (B- CLL) for whom fludarabine combination chemotherapy is not appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION MabCampath should be administered under the supervision of a physician experienced in the use of cancer therapy. Posology During the first week of treatment, MabCampath should be administered in escalating doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3 assuming that each dose is well tolerated. Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days up to a maximum of 12 weeks. In most patients, dose escalation to 30 mg can be accomplished in 3-7 days. However, if acute moderate to severe adverse reactions such as hypotension, rigors, fever, shortness of breath, chills, rashes and bronchospasm (some of which may be due to cytokine release) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated before further dose escalation is attempted (see section 4.4). Median duration of treatment was 11.7 weeks for first-line patients and 9.0 weeks for previously treated patients. Once a patient meets all laboratory and clinical criteria for a complete resp Прочетете целия документ