The data available on efficacy and safety experience with degarelix is limited to a 1 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 Pharmacology: Pharmacodynamics under Actions).
Firmagon has not been studied in patients with a history of a corrected QT interval >450 msec, in patients with a history of or risk factors for Torsades de pointes and in patients receiving concomitant medicinal products that might prolong the QT interval. Therefore, in such patients, the benefit/risk ratio of Firmagon must be thoroughly appraised (see Adverse Reactions and Interactions).
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 Pharmacology: Pharmacokinetics under Actions).
Renal Impairment: Degarelix has not been studied in patients with severe renal impairment and caution is therefore warranted.
Hypersensitivity: Degarelix 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 medical 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 with degarelix.
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.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects of degarelix on the ability to drive and use machines have been performed. However, fatigue and dizziness are common adverse reactions that might influence the ability to drive and use machines.
Use in pregnancy & lactation: There is no relevant indication for use of Firmagon in women.