Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
degarelix
Ferring Pharmaceuticals A/S
L02BX02
degarelix
Endocrine therapy
Prostatic Neoplasms
FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer.- for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.- as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.
Revision: 19
Authorised
2009-02-17
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER FIRMAGON 80 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION degarelix 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 of the 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 FIRMAGON is and what it is used for 2. What you need to know before you use FIRMAGON 3. How to use FIRMAGON 4. Possible side effects 5. How to store FIRMAGON 6. Contents of the pack and other information 1. WHAT FIRMAGON IS AND WHAT IT IS USED FOR FIRMAGON contains degarelix. Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer and for the treatment of high-risk prostate cancer prior to radiotherapy and in combination with radiotherapy in adult male patients. Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its effects. By doing so, degarelix immediately reduces the level of the male hormone testosterone that stimulates the prostate cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FIRMAGON DO NOT USE FIRMAGON − If you are allergic to degarelix or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Please tell your doctor if you have any of the following: − Any cardiovascular conditions or heart rhythm problems (arrythmia), or are being treated with medicines for this condition. The risk of heart rhythm problems may be increased when using FIRMAGON. − Diabetes mellitus. Worsening or onset of diabetes may occur. If you have diabetes, you may have to measure blood glucose more frequently. − Liver disease. Liver function may need to be monitored. − Kidney disease. Use of FIRMAGON has not been investigated in patients with severe kidney disease. − Osteopor Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FIRMAGON 80 mg powder and solvent for solution for injection Each vial contains 80 mg degarelix (as acetate). After reconstitution, each ml of solution contains 20 mg of degarelix. FIRMAGON 120 mg powder and solvent for solution for injection Each vial contains 120 mg degarelix (as acetate). After reconstitution, each ml of solution contains 40 mg of degarelix. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection Powder: white to off-white powder. Solvent: clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated: - for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology STARTING DOSE MAINTENANCE DOSE – MONTHLY ADMINISTRATION 240 mg administered as two consecutive subcutaneous injections of 120 mg each 80 mg administered as one subcutaneous injection The first maintenance dose should be given one month after the starting dose. FIRMAGON may be used as neo-adjuvant or adjuvant therapy in combination with radiotherapy in high-risk localised and locally advanced prostate cancer. The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels. Clinical studies have shown that testosterone (T) suppression occurs immediately after 3 administration of the starting dose with 96% of the patients having serum test Lestu allt skjalið