Plenaxis (Abarelix) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 comorbidities and prostate cancer.

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.