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U.S. Department of Health and Human Services


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Aranesp (darbepoetin alfa)

Audience: Hematology/Oncology, Nephrology and other healthcare professionals

[Posted 12/01/2005] Amgen and FDA notified healthcare professionals of revision to the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Aranesp. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with Aranesp. This has been reported predominantly in patients with CRF receiving Aranesp by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.

[November 2005 - Aranesp Letter - Amgen]
[October 2005 - Aranesp Label - Amgen]