Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
denosumab
Amgen Europe B.V.
M05BX04
denosumab
Drugs for treatment of bone diseases
Fractures, Bone; Neoplasm Metastasis
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Revision: 24
Authorised
2011-07-13
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XGEVA 120 MG SOLUTION FOR INJECTION denosumab 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, pharmacist, or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with XGEVA. WHAT IS IN THIS LEAFLET 1. What XGEVA is and what it is used for 2. What you need to know before you use XGEVA 3. How to use XGEVA 4. Possible side effects 5. How to store XGEVA 6. Contents of the pack and other information 1. WHAT XGEVA IS AND WHAT IT IS USED FOR XGEVA contains denosumab, a protein (monoclonal antibody) that works to slow down bone destruction caused by cancer spreading to the bone (bone metastasis) or by giant cell tumour of bone. XGEVA is used in adults with advanced cancer to prevent serious complications caused by bone metastasis (e.g. fracture, pressure on the spinal cord or the need to receive radiation therapy or surgery). XGEVA is also used to treat giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option, in adults and adolescents whose bones have stopped growing. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE XGEVA DO NOT USE XGEVA - if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6). Your healthcare professional will not administer XGEVA to you if you have a very low level of calcium in your blood which has not been treated. Your healthcare professional will not administe Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT XGEVA 120 mg solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL). _ _ Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology. Excipient with known effects Each 1.7 mL of solution contains 78 mg sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION XGEVA should be administered under the responsibility of a healthcare professional. Posology Supplementation of at least 500 mg calcium and 400 IU vitamin D daily is required in all patients, unless hypercalcaemia is present (see section 4.4). Patients treated with XGEVA should be given the package leaflet and the patient reminder card. _Prevention of skeletal related events in adults with advanced malignancies involving bone _ The recommended dose is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm. _Giant cell tumour of bone _ The recommended dose of XGEVA is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy. 3 Patients in the phase II study who underwent complete Lire le document complet