"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
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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.
Read the Plenaxis (abarelix) Side Effects Center for a complete guide to possible side effects
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%).
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/26/2011
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