IMPORTANT SAFETY INFORMATION ABOUT ZOLADEX^® (goserelin acetate implant)

ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.

The most common adverse events (incidence >5% in clinical trials) were: for ZOLADEX 3.6-mg depot — hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%). For ZOLADEX 10.8-mg depot — hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%).

ZOLADEX is also indicated for use in combination with flutamide for the management of locally advanced Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with the combination should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).

Please see full Prescribing Information for ZOLADEX.