Ferring

INDICATIONS AND USAGE

FIRMAGON^® is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.

IMPORTANT SAFETY INFORMATION

FIRMAGON^® is contraindicated in patients with a known hypersensitivity to degarelix or to any of the product components and in women who are or may become pregnant. FIRMAGON^® can cause fetal harm when administered to a pregnant woman.

Long-term androgen deprivation therapy (ADT) prolongs the QT interval. Physicians should consider whether the benefits of ADT outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA or Class III antiarrhythmic medications.

Diagnostic test results of pituitary gonadotropic and gonadal functions conducted during and after FIRMAGON^® may be affected. The therapeutic effect of FIRMAGON^® should be periodically monitored by measuring serum concentrations of PSA; if PSA increases, serum concentrations of testosterone should be measured.

The most common adverse reactions (?10%) during FIRMAGON^® therapy included injection site reactions (eg, pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase. The majority of adverse reactions were Grade 1 or 2; 1% or less were Grade 3/4. Injection site reactions were mostly transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%).