Prostate cancer develops when cells in the prostate gland begin to multiply quickly. This means that new cells form where the body does not need them and old cells do not die when they should. These extra cells form a mass of tissue called a tumor. The tumor is described as being "malignant" if the cells have the ability to spread beyond the area in which they first developed.
Prostate cancer usually grows slowly and can remain within the prostate gland for years (localized cancer). However, as the cancer develops, it can invade and damage the surrounding tissues or spread to other areas of the body (metastasis).
INDICATIONS AND USAGE
FIRMAGON® is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.
IMPORTANT SAFETY INFORMATION
The most commonly observed adverse reactions during FIRMAGON® therapy included injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). 99% of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in 2% or less of patients receiving FIRMAGON®.
FIRMAGON® is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. FIRMAGON® is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications.
Please see the Full Prescribing Information. You can view or download it by clicking on the link in the right-hand column of the page.
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