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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.

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.

Drug label data at the top of this Page last updated: 2006-02-18

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