Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Degarelix acetate
Ferring Pharmaceuticals Ltd
L02BX02
Degarelix acetate
80mg
Powder and solvent for solution for injection
Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5015919788821
2009054354 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. Rare (may affect up to 1 in 1,000 people) - febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart failure. REPORTING OF SIDE EFFECTS If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Ireland Do not use this medicine after the expiry date which is stated on the vials, syringes and outer packaging. The expiry date refers to the last day of that month. FIRMAGON contains degarelix. Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult male patients. Degarelix mimics a natural hormone (gonadotrophin-releasing 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. 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. - Osteoporosis or any condition that affects the strength of your bones. Reduced level of testosterone may cause a reduction in bone calcium (thinning of bones). - Severe hypersensitivity. Use of FIRMAGON has not been investigated in patients with severe hypersensitivit Read the complete document
OBJECT 1 FIRMAGON 80MG INJECTION Summary of Product Characteristics Updated 21-Mar-2017 | Ferring Pharmaceuticals Ltd 1. Name of the medicinal product FIRMAGON 80 mg powder and solvent for solution for injection 2. Qualitative and quantitative composition Each vial contains 80 mg degarelix (as acetate). After reconstitution, each ml of solution contains 20 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. 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. 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 populations _Elderly, hepatically or renally impaired patients:_ There is no need to ad Read the complete document