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).
|Hot flushes*||64 (79)|
|Sleep disturbance*||36 (44)|
|Breast enlargement*||24 (30)|
|Breast pain/nipple tenderness*||16 (20)|
|Back pain||14 (17)|
|Peripheral edema||12 (15)|
|Upper respiratory tract infection||10 (12)|
|Micturition frequency||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.