Drugs
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 (updated 1/2009)
Aranesp Information
- Package Insert [PDF] (labeling)
- Medication Guide [PDF]
- Medication Guide letter [PDF]
- Approval History for Aranesp from Drugs@FDA
Epogen and Procrit Information
- Package Insert (labeling)
- Medication Guides
- Epogen [PDF]
- Procrit [PDF]
- Medication Guide letter [PDF]
- Approval History for Epogen and Procrit from Drugs@FDA
Eprex Information
- Early Communication about an Ongoing Safety Review: Epoetin alfa (9/26/2008) FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke.
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.
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