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 RATESWITH FIRMAGON VS LEUPROLIDE||FIRMAGON 240/80 mg |
|Leuprolide 7.5 mg |
|Percentage of subjects with adverse events||79%||78%|
|Body as a whole|
|Injection site adverse events||35%/4%*||<1%|
|Urinary tract infection||5%||9%|
|Increases in transaminases and GGT||10%||5%|
N = 207
N = 201
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 FIRMAGON
In an extension study, 135 patients crossed over from leuprolide to FIRMAGON.
Abbreviations: ADT = androgen deprivation therapy; QTcF = QT Interval Corrected by the Fridericia Correction Formula.
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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.