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Full Prescribing Information
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

How Many Men Are Affected?

Prostate cancer is the most common cancer in men in developed nations and the third most prevalent cancer in the world.

  • 679,000 men worldwide live with prostate cancer.
  • It is estimated that 1 in 6 men will develop the disease during their lifetime.
  • Three-quarters of all cases are in men aged 65 years or older.
  • Mortality rates have been declining in some developed nations because of better detection and screening.
  • Most prostate cancers are slow growing and do not reduce life expectancy.
  • The introduction of the PSA test (prostate-specific antigen test) and screening programs are linked to increased detection and therefore the increased incidence of prostate cancer observed in many countries. This testing has enabled many men to access treatment far earlier than was previously possible.
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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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