FIRMAGON® (degarelix for injection) is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.
Important Safety Information
FIRMAGON is contraindicated in patients with a history of severe hypersensitivity to degarelix or to any of the product components.
Hypersensitivity reactions, including anaphylaxis, urticaria, and angioedema, have been reported post-marketing with FIRMAGON. In case of a serious hypersensitivity reaction, discontinue FIRMAGON immediately if the injection has not been completed, and manage as clinically indicated. Patients with a known history of severe hypersensitivity reactions to FIRMAGON should not be re-challenged with FIRMAGON.
FIRMAGON is contraindicated in women who are or may become pregnant. FIRMAGON can cause fetal harm and loss of pregnancy when administered to a pregnant woman.
Long-term androgen deprivation therapy (ADT) may prolong 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 drugs known to prolong the QT interval (e.g., Class IA or Class III antiarrhythmic medications.)
Therapy with FIRMAGON results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after FIRMAGON may be affected. The therapeutic effect of FIRMAGON should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured.
The most common adverse reactions (≥10%) during FIRMAGON therapy included injection site reactions (e.g., pain, erythema, swelling, induration or inflammation), pyrexia, hot flashes, weight loss or gain, 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%).
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Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
You may also contact Ferring Pharmaceuticals Inc. at 1-888-FERRING.