Country: Israel
Language: English
Source: Ministry of Health
DEGARELIX AS ACETATE
FERRING PHARMACEUTICALS LTD
L02BX02
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
DEGARELIX AS ACETATE 120 MG
S.C
Required
FERRING GmbH ,GERMANY
DEGARELIX
For the treatment of adult male patients with advanced hormone-dependent prostate cancer.
2020-02-02
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied by doctor’s prescription only FIRMAGON 80 MG FIRMAGON 120 MG POWDER AND SOLVENT FOR PREPARING A SOLUTION FOR SUBCUTANEOUS INJECTION COMPOSITION: FIRMAGON 80 MG contains: degarelix (as acetate) 80 mg FIRMAGON 120 MG contains: degarelix (as acetate) 120 mg Inactive ingredients – see section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or the pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. This medicine is intended for adult men only. This medicine is not intended for women. 1. WHAT IS THIS MEDICINE INTENDED FOR? For treatment of advanced prostate cancer in adult men. THERAPEUTIC GROUP: GnRH antagonist. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to the active ingredient or to any of the other ingredients that this medicine contains. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: BEFORE THE TREATMENT WITH FIRMAGON, TELL YOUR DOCTOR IF: • You have diabetes; your existing diabetes may get worse. If you did not have diabetes previously it may occur now. If you have diabetes you must measure glucose levels in your blood more often. • You have problems with your heart, blood vessels, or heart-rate (heart rhythm disorders- arrhythmia), or if you have been given medication to treat this problem. Heart rhythm disorders may get worse while using Firmagon. • You have or have had in the past impaired function of the liver. Liver function must be monitored. • You have kidney disease. Treatment with Firmagon has not been tested in patients with severe kidney disease. • You have osteoporosis or any other condition which may affect Read the complete document
1 1. NAME OF THE MEDICINAL PRODUCT FIRMAGON 120 mg FIRMAGON 80 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 120 mg degarelix (as acetate). After reconstitution, each ml solution contains 40 mg of degarelix. Each vial contains 80 mg degarelix (as acetate). After reconstitution,each ml of solution contains 20 mg of degarelix. For a 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. 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. 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 administration of the starting dose with 96% of the patients having serum testosterone levels corresponding to medical castration (T ≤ 0.5 ng/ml) after three days and 100% after one month. Long term treatment with the maintenance dose up to 1 year shows that 97% of the patients have sustained suppressed testosterone levels (T ≤ 0.5 ng/ml). In case the patient's clinical response appears to be sub-optimal, it should be confirmed that serum testosterone levels are remaining sufficiently suppressed. 2 Since degarelix does not induce a testosterone surge it is not necessary to add an anti-androgen as surge protection at initiation of therapy . Special patient populations _Elderly, hepatically or renally impaired patients: _ There is no need to adjust the dose f Read the complete document