Starting Dose: 240 mg administered as 2 SC inj of 120 mg each. Monthly Maintenance Dose: 80 mg administered as 1 SC inj.
The 1st maintenance dose should be given 1 month after the starting dose.
The therapeutic effect of degarelix should be monitored by clinical parameters and PSA serum levels. Clinical studies have shown that testosterone suppression occurs immediately after administration of the starting dose with 96% of the patients having plasma testosterone levels corresponding to medical castration (T≤0.5 ng/mL) after 3 days and 100% after 1 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 antiandrogen as surge protection at initiation of therapy.
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.
Administration: Firmagon must be reconstituted prior to administration. For instructions on reconstitution and administration, see Instructions for Use under Cautions for Usage.
SC use only, not to be administered IV.
Intramuscular administration is not recommended as it has not been studied.
Firmagon is administered as a SC injection in the abdominal region. As with other medicinal products administered by SC injection, the injection site should vary periodically. Injections should be given in areas where the patient will not be exposed to pressure eg, not close to waistband or belt and not close to the ribs.