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Degarelix (FIRMAGON(R)) vs Leuprolide (Lupron Depot(R)) in Patients With Advanced Prostate Cancer: Further Analysis From a Phase III Pivotal Trial
Date:12/4/2009

rolide, an established treatment for prostate cancer, FIRMAGON does not induce an initial testosterone surge. FIRMAGON is administered monthly by subcutaneous injection. The starting dose is 240 mg, followed by monthly maintenance doses of 80 mg. FIRMAGON is available for order through traditional and specialty pharmacy distributors. The average monthly cost of one year of FIRMAGON treatment is comparable to other hormone treatments for prostate cancer.

The most commonly observed adverse reactions during FIRMAGON therapy included injection site reactions (e.g. pain, erythema, swelling or induration) and other androgen deprivation therapy (ADT) associated side effects including hot flashes, increased weight and fatigue. Ninety-nine percent 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 two percent 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 ADT 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.

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of infertility, urology, and orthopaedic produc
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SOURCE Ferring Pharmaceuticals Inc.
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