FIRMAGON^® (degarelix for injection) DROPS PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS

Drop in T Levels

Patient Castrate Levels

Reduction in PSA Levels

When Testosterone drops, PSA reduction follows

FIRMAGON RESULTED IN A REDUCTION OF PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS, A SECONDARY ENDPOINT¹*

View Safety Profile

REDUCTION IN PSA LEVELS FOR PATIENTS RECEIVING FIRMAGON (N=207)¹

Chart showing how Firmagon® maintained prostate-specific antigen suppression through 12 months of treatment

FIRMAGON maintained PSA suppression through 12 months of treatment¹

START T SUPPRESSION TODAY¹

Prostate-specific antigen (PSA) level is a nonspecific measurement that may indicate cancer progression. These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to clinical benefit. Therefore, PSA data should not be viewed independently as evidence of the effectiveness of FIRMAGON.¹

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^®).² 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 ENDPOINT²:

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

KEY SECONDARY ENDPOINTS²:

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 to 14-28 days

Abbreviations: ADT = androgen deprivation therapy; FSH = follicle-stimulating hormone; LH = luteinizing hormone; PSA = prostate-specific antigen; T = testosterone.

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. 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.

Indication

FIRMAGON^® (degarelix for injection) is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.

Important Safety Information

FIRMAGON is contraindicated in patients with a history of severe hypersensitivity to degarelix or to any of the product components.

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

FIRMAGON is contraindicated in women who are or may become pregnant. FIRMAGON can cause fetal harm and loss of pregnancy when administered to a pregnant woman.

Long-term androgen deprivation therapy (ADT) may prolong 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 drugs known to prolong the QT interval (e.g., 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 (e.g., pain, erythema, swelling, induration or inflammation), pyrexia, hot flashes, weight loss or gain, 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%).

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

You may also contact Ferring Pharmaceuticals Inc. at 1-888-FERRING.

FIRMAGON® (degarelix for injection) DROPS PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS

When Testosterone drops, PSA reduction follows

FIRMAGON RESULTED IN A REDUCTION OF PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS, A SECONDARY ENDPOINT1*

REDUCTION IN PSA LEVELS FOR PATIENTS RECEIVING FIRMAGON (N=207)1

START T SUPPRESSION TODAY1

Study Design

PRIMARY ENDPOINT2:

KEY SECONDARY ENDPOINTS2: