Firmagon Dosage/Direction for Use

Posology: (See Table 3.)

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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, see Instructions For Use under Cautions for Usage.
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 Pharmacology: Pharmacokinetics under Actions). Patients with severe liver or kidney impairment have not been studied and caution is therefore warranted (see Precautions).
There is no relevant indication for use of FIRMAGON in women, children and adolescents.