PLENAXIS SIDE EFFECTS
- Generic Name: abarelix
- Brand Name: Plenaxis
- Drug Class: Gonadotropin Releasing Hormone Antagonists
SIDE EFFECTS
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.
SRC: NLM .