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Immediate-Onset Systemic Allergic Reactions: See BOXED WARNINGS and WARNINGS

In the single study of Plenaxis™ conducted in men with advanced symptomatic prostate cancer, adverse events reported by ≥ 10% of patients are listed in Table 4. Adverse events are listed without regard to causality. Causality is often difficult to assess in elderly patients with multiple co-morbidities and prostate cancer.

Table 4: Adverse Events in ≥ 10% of Patients in the Advanced Symptomatic Prostate Cancer Study (without regard for causality).

Preferred Term Plenaxis™
N=81
n (%)
Hot flushes* 64 (79)
Sleep disturbance* 36 (44)
Pain 25 (31)
Breast enlargement* 24 (30)
Breast pain/nipple tenderness* 16 (20)
Back pain 14 (17)
Constipation 12 (15)
Peripheral edema 12 (15)
Dizziness 10 (12)
Headache 10 (12)
Upper respiratory tract infection 10 (12)
Diarrhea 9 (11)
Dysuria 8 (10)
Fatigue 8 (10)
Micturition frequency 8 (10)
Nausea 8 (10)
Urinary retention 8 (10)
Urinary tract infection 8 (10)
* Pharmacological consequence of androgen deprivation

Changes in Laboratory Values

Clinically meaningful increases in serum transaminases were seen in a small percentage of patients in both treatment groups in each active-controlled Plenaxis™ study. In Study 1 and Study 2 combined, the percentage of Plenaxis™ patients reporting serum ALT > 2.5 times upper limit of normal or > 200 U./L was 8.2% and 1.8%, respectively. The percentage reporting serum AST > 2.5 times upper limit of normal or > 200 U/L was 3.1% and 0.8%, respectively. Similar results were reported for active comparators.

Slight decrease in hemoglobin, a pharmacological consequence of castration, were observed in patients receiving Plenaxis™ and active comparator. Mean increases in serum triglycerides of approximately 10% were seen in Plenaxis™ -treated patients.