Amgen Revises Labeling on Erythropoietin-stimulating Agents
Amgen, in collaboration with the United States Food and Drug Administration (FDA) and Johnson and Johnson Pharmaceutical Research & Development, has updated package inserts for Aranesp® (darbepoetin alfa) and Epogen®/Procrit® (epoetin alfa).
The labeling changes include revisions to the boxed warnings, additions to the indication and usage section and the warnings section, as well as clarification of target hemoglobin range for patients with chronic renal failure patients.
The boxed warning includes “The risks of shortened survival and tumor promotion have not been excluded when ESAs are dosed to target a hemoglobin of less than 12 g/dL. To minimize these risks as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.”
The revisions also recommend that physicians stop using ESAs once chemotherapy courses are completed and not to exceed hemoglobin levels of 12 g/dL.
Reference: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01740.html Accessed, November 8, 2007.
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