Information on Erythropoiesis-Stimulating Agents (ESAs)
Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp)
Update
In August, 2008, Amgen submitted labeling supplements for Epogen/Procrit and Aranesp in response to FDAs Safety Labeling Change Order, issued under the authority of section 505(o)(4)(E) of the Federal Food, Drug and Cosmetic Act (FDCA). FDA approved these changes, which include the replacement of the existing Patient Package Insert with a Medication Guide and the revision of the Boxed Warning, Indications and Usage, Warnings and Dosage and Administration sections of the package insert. Access to the approval letter and labeling are provided below.
Questions and Answers on Medication Guides for ESAs (12/2/2008)
Aranesp Information
Epogen and Procrit Information
Eprex Information
Historical Information
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Date created: November 16, 2006, updated December 2, 2008 |