BlackBoxRX
 
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Peginesatide

ESAs Increase the Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism, Thrombosis of Vascular Access, and Tumor Progression or Recurrence

Chronic Kidney Disease

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
  • Use the lowest peginesatide dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Approved Risk Evaluation and Mitigation Strategies (REMS)

OMONTYS (Peginesatide) Injection

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Peginesatide

Additional Information

Drug Discontinued

Updated February 2016