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

• OMONTYS

Medication Guides

Patient Medication Guide

Package Inserts

Peginesatide

Additional Information

Drug Discontinued