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].
- 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
Patient Counseling Information