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Aranesp (darbepoetin alfa) - Jan 14, 2005

January 14, 2005

Audience: Oncologists, hematologists and other healthcare professionals

FDA and Amgen notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Aranesp, indicated for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. This safety information alerts physicians to the adverse effects observed with other products in this class in association with off-label dosing strategies. Two recent investigational studies with other erythropoietic products permitted or required dosing to achieve hemoglobin levels of greater than 12 grams per deciliter. An increased frequency of adverse patient outcomes, including increased mortality and thrombotic vascular events were reported in these studies. As indicated in the Aranesp prescribing information, the target hemoglobin level should not exceed 12 grams per deciliter in men or women.

[January 11, 2005 - Letter - Amgen]
[December 16, 2004 - Label - Amgen]

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