FIRMAGON^® (degarelix for injection) HAS A PROVEN SAFETY PROFILE OF OVER 5 YEARS

FIRMAGON SIDE EFFECTS

ADVERSE EVENT RATES WITH FIRMAGON VS LEUPROLIDE

ADVERSE EVENT RATES REPORTED IN ≥5% OF PATIENTS WITH FIRMAGON VS LEUPROLIDE	FIRMAGON 240/80 mg (subcutaneous) N=207	Leuprolide 7.5 mg (intramuscular) N=201
Percentage of subjects with adverse events	79%	78%
Body as a whole
Injection site adverse events	35%/4%^*	<1%
Weight increase	9%	12%
Fatigue	3%	6%
Chills	5%	0%
Cardiovascular system
Hot flash	26%	21%
Hypertension	6%	4%
Musculoskeletal system
Back pain	6%	8%
Arthralgia	5%	9%
Urogenital system
Urinary tract infection	5%	9%
Digestive system
Increases in transaminases and GGT	10%	5%
Constipation	5%	5%

FIRMAGON

240/80 mg

(subcutaneous)

N = 207

leuprolide

7.5 mg

(intramuscular)

 N = 201

Percentage of subjects with adverse events

79%

78%

Body as a whole Injection site adverse events

35%^*

<1%

Body as a wholeWeight increase

12%

Body as a wholeFatigue

Body as a wholeChills

Cardiovascular systemHot Flash

26%

21%

Cardiovascular systemHypertension

Musculoskeletal systemBack pain

Musculoskeletal systemArthralgia

Urogenital systemUrinary track infection

Digestive systemIncreases in transaminases and GGT

10%

Digestive system Constipation

The most common adverse reactions reported in ≥10% of the patients were injection site reactions (eg, pain, erythema, swelling, induration, or inflammation), pyrexia, hot flush, weight loss or gain, fatigue, and increases in serum levels of hepatic transaminases and gamma-glutamyltransferase (GGT).

In the pivotal trial, <1% of patients (n=7) in the pooled FIRMAGON group, compared to 2% of patients (n=4) in the leuprolide group, had a QTcF ≥500 msec. From baseline to end of study, the median change for FIRMAGON was 12.3 msec and 16.7 msec for leuprolide.¹

*Injection site reactions occurred in only 4% of maintenance dose injections.²

Patients have safely switched from leuprolide to FIRMAGON¹

In an extension study, 135 patients crossed over from leuprolide to FIRMAGON. During followup, testosterone- and prostate-specific antigen suppression were similar to those in the 1-year trial in patients who continued on degarelix or switched from leuprolide. Adverse event frequency was similar between the groups and decreased with time.^1,3

Abbreviations: ADT = androgen deprivation therapy; QTcF = QT Interval Corrected by the Fridericia Correction Formula.

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.

One-month depot is ideal for my patients. They love to come in, get checked, and see their nurse practitioner to ask questions and get updated data about their condition.

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. 3. Crawford ED, Tombal B, Miller K, et al. A Phase III Extension Trial With a 1-Arm Crossover From Leuprolide to Degarelix: Comparison of Gonadotropin-Releasing Hormone Agonist and Antagonist Effect on Prostate Cancer. J Urol. 2011;186(3):889-897.

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) HAS A PROVEN SAFETY PROFILE OF OVER 5 YEARS