Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
water for injections, Quantity: 4.2 mL
Ferring Pharmaceuticals Pty Ltd
Degarelix,water for injections
Injection
Excipient Ingredients:
Subcutaneous
1x80mg vial and 1 diluent syringe
(S4) Prescription Only Medicine
FIRMAGON is a GnRH receptor blocker indicated for treatment of patients with prostate cancer in whom androgen deprivation is warranted.
Visual Identification: Clear, colourless; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2012-10-31
FIRMAGON ® _Degarelix (as acetate)_ POWDER AND SOLVENT FOR INJECTION, DEPOT CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Firmagon. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking/being given Firmagon against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FIRMAGON IS USED FOR Firmagon contains degarelix. Degarelix is a synthetic hormone that reduces the level of the male hormone, testosterone. Firmagon is used to treat: • prostate cancer Firmagon may slow or stop the growth of cancer. Firmagon should only be taken by men. It should not be taken by women or children. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FIRMAGON HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Firmagon for another reason. Firmagon is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN FIRMAGON _WHEN YOU MUST NOT BE GIVEN_ _IT_ FIRMAGON WILL NOT BE GIVEN IF YOU HAVE AN ALLERGY TO: • degarelix, the active ingredient in Firmagon or any similar drugs, known as GnRH antagonists (blockers) • any of the other ingredients of Firmagon listed at the end of this leaflet. Symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. YOU MUST NOT BE GIVEN FIRMAGON AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. YOU MUST NOT BE GIVEN FIRMAGON IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. _BEFORE YOU ARE GIVEN IT_ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO: • any other medicines • any ot Read the complete document
1 #22606-v16A AUSTRALIAN PI - FIRMAGON ® (DEGARELIX (AS ACETATE)) POWDER AND SOLVENT FOR INJECTION, DEPOT 1 NAME OF THE MEDICINE Degarelix (as acetate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The sterile powder is a freeze-dried product containing degarelix (as the acetate) and mannitol. The solvent consists of sterile water for injections. FIRMAGON delivers degarelix acetate, equivalent to 120 mg of degarelix for the starting dose, and 80 mg of degarelix for the maintenance dose. The 80 mg vial contains 200 mg mannitol and the 120 mg vial contains 150 mg mannitol. 3 PHARMACEUTICAL FORM Degarelix is a third generation gonadotrophin releasing hormone (GnRH) antagonist (blocker). It is a synthetic decapeptide, which forms a depot following subcutaneous injection; this depot formation results in a sustained release of degarelix. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FIRMAGON is a GnRH receptor blocker indicated for treatment of patients with prostate cancer in whom androgen deprivation is warranted. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE FOR ADULT MALES STARTING DOSE MAINTENANCE DOSE – MONTHLY ADMINISTRATION 240 mg administered as two s.c. injections of 120 mg at a concentration of 40 mg/mL 80 mg administered as one s.c. injection at a concentration of 20 mg/mL The first maintenance dose should be given one month after the starting dose. The therapeutic effect of FIRMAGON should be monitored by clinical parameters and by measuring 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 plasma testosterone at medical castration levels (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 su Read the complete document