Firmagon

/ Ferring Pharmaceuticals

See prescribing information for full details.

For the treatment of adult male patients with advanced hormone-dependent prostate cancer.

Hypersensitivity to the active substance or to any of the excipients.

The data available on efficacy and safety is limited to a one year treatment.Effect on QT/QTc interval: Long-term androgen deprivation therapy may prolong the QT interval. In the confirmatory study comparing Firmagon to leuprorelin periodic (monthly) ECGs were performed; both therapies showed QT/QTc intervals exceeding 450 msec in approximately 20% of the patients, and 500 msec in 1% and 2% of the degarelix and leuprorelin patients, respectively. See prescribing information for full details. Treatment has not been studied in patients with a history of a corrected QT interval over 450 msec, in patients with a history of or risk factors for torsades de pointes and in patients receiving concomitant medicdbinal products that might prolong the QT interval. Therefore in such patients, the benefit/risk ratio must be thoroughly appraised. See prescribing information for full details. Hepatic impairment: Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with degarelix. Mild, transient increases in ALT and AST have been seen, these were not accompanied by a rise in bilirubin or clinical symptoms. Monitoring of liver function in patients with known or suspected hepatic disorder is advised during treatment. The pharmacokinetics of degarelix has been investigated after single IV administration in subjects with mild to moderate hepatic impairment. See prescribing information for full details. Renal impairment: Has not been studied in patients with severe renal impairment and caution is therefore warranted. Hypersensitivity: Has not been studied in patients with a history of severe untreated asthma, anaphylactic reactions or severe urticaria or angioedema.Changes in bone density: Decreased bone density has been reported in the medicdbal literature in men who have had orchiectomy or who have been treated with a GnRH agonist. It can be anticipated that long periods of testosterone suppression in men will have effects on bone density. Bone density has not been measured during treatment.Glucose tolerance: A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist. Development or aggravation of diabetes may occur; therefore diabetic patients may require more frequent monitoring of blood glucose when receiving androgen deprivation therapy. The effect of degarelix on insulin and glucose levels has not been studied.

The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study (N=409) were due to the expected physiological effects of testosterone suppression, including hot flushes and weight increase (reported in 25% and 7%, respectively, of patients receiving treatment for one year), or injection site adverse events. Transient chills, fever or influenza like illness were reported to occur hours after dosing (in 3%, 2% and 1% of patients, respectively).The injection site adverse events reported were mainly pain and erythema, reported in 28% and 17% of patients, respectively, less frequently reported were swelling (6%), induration (4%) and nodule (3%).
See prescribing information for full details.

No formal drug-drug interaction studies have been performed.
See prescribing information for full details.