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FIRMAGON® Results in Fast, Long-Term Suppression of Testosterone in Prostate Cancer Patients Without Initial Testosterone Surge
Date:6/1/2010

RMAGON® was shown to be non - inferior to leuprolide in sustaining castrate levels of testosterone from Days 28 – 364. This trial formed the primary basis for the successful Food and Drug Administration (FDA) approval of FIRMAGON® in December, 2008.  The study results showed that at day 3 of treatment, 96% of FIRMAGON® patients achieved castrate levels of testosterone, compared with zero percent receiving leuprolide. The median testosterone level with FIRMAGON® treatment was sustained at <9 ng/dL with no initial testosterone surge or microsurge following maintenance injections throughout the one-year study.

More About FIRMAGON

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.

Important Safety Information

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 ADT 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. 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 level
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SOURCE Ferring Pharmaceuticals Inc.
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