FIRMAGON Powder and Solvent for Solution for Injection 80 mg

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

Therapeutic

Prescription Only

INJECTION, POWDER, FOR SOLUTION

**POSOLOGY AND METHOD OF ADMINISTRATION** Posology  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. Method of administration FIRMAGON® must be reconstituted prior to administration. For instructions on reconstitution and administration, please see section Instructions For Use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **FIRMAGON® is for subcutaneous use ONLY**, not to be administered intravenously. Intramuscular administration is not recommended as it has not been studied. FIRMAGON® is administered as a subcutaneous injection in the abdominal region. The injection site should vary periodically. Injections should be given in areas where the patient will not be exposed to pressure e.g. not close to waistband or belt and not close to the ribs. Special patient populations _Elderly, hepatically or renally impaired patients:_ There is no need to adjust the dose for the elderly or in patients with mild or moderate liver or kidney function impairment (see section Pharmacokinetic Properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with severe liver or kidney impairment have not been studied and caution is therefore warranted (see section Special Warnings and Precautions for Use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). There is no relevant indication for use of FIRMAGON® in women, children and adolescents.