YOU DON’T HAVE TO WAIT TO DROP TESTOSTERONE (T)

Drop in T Levels

Patient Castrate Levels

Reduction in PSA Levels

FIRMAGON^® (degarelix for injection) WAS PROVEN TO DROP T BY 88% ON DAY 1^1,2

View Safety Profile

Change in T Levels From Baseline Over 28 Days¹

+43%

+65%

+8%

–75%

–97%

–88%

–94%

–96%

–97%

–98%

Chart showing change in testosterone levels over 28 days

Use of the LHRH agonist leuprolide led to an initial 65% increase in testosterone over the first 3 days compared to a reduction of 94% with FIRMAGON.^2,3

Study Design

The pivotal phase 3 trial (CS21) was a 3-armed, randomized (1:1:1), active-controlled, open-label, parallel-group, 12-month clinical study of FIRMAGON compared to leuprolide acetate (Lupron Depot^®).³ Serum levels of testosterone were measured at screening, on days 0, 1, 3, 7, 14,
and 28 in the first month, and then monthly until the end of the study.¹

PRIMARY ENDPOINT³:

FIRMAGON was shown to maintain testosterone suppression below castration level (≤50 ng/dL) during 12 months of treatment.

SECONDARY ENDPOINTS³:

Proportion of patients with testosterone ≤50 ng/dL
Serum levels of testosterone, prostate-specific antigen (PSA), luteinizing hormone (LH), and follicle-stimulating hormone (FSH) over time
Percentage change in PSA from baseline

Abbreviations: T = testosterone.

Lupron Depot is a registered trademark of ABBVIE ENDOCRINE INC.

Monthly Matters

Help make the most of your patient's treatment experience

Make the most of monthly visits. Help your patients feel connected to their therapy through the reassurance of regular treatment and progress check-ins. Ferring is here to help enhance this connection at every step.

I like the regularity of the monthly shot and the chance it gives me to build a relationship with my treatment team.

Actual physician quote

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.

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.

YOU DON’T HAVE TO WAIT TO DROP TESTOSTERONE (T)

FIRMAGON® (degarelix for injection) WAS PROVEN TO DROP T BY 88% ON DAY 11,2

Change in T Levels From Baseline Over 28 Days1