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Prescribing Information Changes for Erythropoiesis Stimulating Agents

August 8, 2008

Source: The Food and Drug Administration

Amgen, the manufacturer of Erythropoiesis Stimulating Agents (ESAs), medications used by cancer and renal failure patients, is now required to include additional safety information regarding prescribing and usage.

Amgen and the FDA informed healthcare professionals of recent modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for these medications. Common ESAs include Epoetin alfa (marketed as Procrit, Epogen) and Darbepoetin alfa (marketed as Aranesp).

These prescribing and usage modifications state the FDA approved conditions for use of ESAs in patients with cancer, and revise directions for dosing to clarify the appropriate hemoglobin level at which treatment with an ESA should be initiated.

In addition, these prescribing updates make it clear that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure. Details on when to initiate and discontinue ESA dosing will be forthcoming.

Before starting or continuing therapy with ESAs, health care professionals are encouraged to discuss with their patients the benefits as well as the potential or demonstrated risks of treatment with ESAs.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Follow Up to an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA2.