In the treatment of advanced prostate cancer (APC) with hormone therapy

Why Wait to Lower Testosterone?

It Drops THAT Fast

FIRMAGON® (degarelix for injection), the GnRH receptor antagonist, is the only ADT proven to drop T by 88% on day 1 (N=207)1,2

PRIMARY ENDPOINT: FIRMAGON maintained testosterone suppression below castration level (≤50 ng/dL) over 364 days of treatment.3

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FIRMAGON, the only GnRH antagonist, directly blocks the pituitary GnRH receptors1
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FIRMAGON is approved for all stages of APC

FIRMAGON is proven to suppress T in all stages of APC3

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Abbreviations: GnRH = gonadotropin-releasing hormone; T = testosterone.

REFERENCES: 1. FIRMAGON [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.2. Data on file. Ferring Pharmaceuticals Inc.3. Klotz L, Boccon-Gibod L, Shore ND, et al. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008;102(11):1531-1538.

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Important Safety Information

FIRMAGON is contraindicated in patients with a known hypersensitivity to degarelix or to any of the product components and in women who are or may become pregnant. FIRMAGON can cause fetal harm when administered to a pregnant woman.

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 serious hypersensitivity reactions to FIRMAGON should not be re-challenged with FIRMAGON.

Long-term androgen deprivation therapy (ADT) 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 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 (eg, pain, erythema, swelling, or induration), hot flashes, increased weight, 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%).

Indication

FIRMAGON® is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.

Important Safety Information

FIRMAGON is contraindicated in patients with a known hypersensitivity to degarelix or to any of the product components and in women who are or may become pregnant. FIRMAGON can cause fetal harm when administered to a pregnant woman.

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 serious hypersensitivity reactions to FIRMAGON should not be re-challenged with FIRMAGON.

Long-term androgen deprivation therapy (ADT) 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 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 (eg, pain, erythema, swelling, or induration), hot flashes, increased weight, 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%).

Indication

FIRMAGON® is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.