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.

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.

No formal drug/drug interaction studies with Plenaxis™ were performed. Cytochrome P-450 is not known to be involved in the metabolism of Plenaxis™. Plenaxis™ is highly bound to plasma proteins (96 to 99%).

Laboratory Tests

Response to Plenaxis™ should be monitored by measuring serum total testosterone concentrations just prior to administration on Day 29 and every 8 weeks thereafter (see WARNINGS). Serum transaminase levels should be obtained before starting treatment with Plenaxis™ and periodically during treatment. Periodic measurement of serum PSA levels may also be considered.

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