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Darbepoetin alfa, Epoetin alfa

Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Increased Risk of 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 ESA dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions].

Cancer

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers [see Table 2, Warnings and Precautions].
  • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Epogen or Aranesp to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance [see Warnings and Precautions].
  • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration].
  •  Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage].
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage].
  • Discontinue following the completion of a chemotherapy course [see Dosage and Administration].

 

Perisurgery (Epoetin alfa only)

  • Epoetin alfa increases the risk of deep venous thromboses, deep venous thrombosis prophylaxis is recommended.

FDA and Industry Communications

Index to FDA Drug Safety Information

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Epogen

Aranesp

Updated June 2018