1. Aschenbrenner, Diane S. MS, APRN, BC

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Erythropoiesis-stimulating agents (Aranesp, Epogen, and Procrit), used to treat anemia secondary to chronic renal failure or to chemotherapy, are exogenous forms of erythropoietin that stimulate the production of red blood cells. The black box warning on the labeling of these agents has been recently revised to emphasize the risks posed by off-label usage. The revised warning states that use of the agents at doses intended to raise the hemoglobin level to 12 g/dL or higher can promote the progression of tumor growth and shorten the duration of survival in patients with advanced breast, head and neck, lymphoid, or non-small cell lung cancer (a level below 12 g/dL is the treatment goal indicated in the product labeling). It also states that there are no clinical data determinative of a comparable risk posed when the treatment goal remains below 12 g/dL, the hemoglobin level commonly sought in clinical practice. The therapy should be discontinued when the treatment goal has been reached.


The revised warning also states that these agents should be used in patients with cancer only in the treatment of anemia caused by chemotherapy, and that quality of life and symptoms of anemia and fatigue are not improved by erythropoiesis-stimulation therapy in such patients.


The warning also states that in patients with chronic renal failure the treatment goal is a hemoglobin level of 10 to 12 g/dL, and that maintaining a higher level in such patients increases the risk of serious cardiovascular events such as stroke, heart attack, and heart failure, as well as death. Further revisions to the labeling specify instructions for adjustment of the dosage and for monitoring the hemoglobin level in patients with chronic renal failure who are unresponsive to the agents.


Nurses should be aware of the revised warnings and should monitor the hemoglobin level closely in patients receiving erythropoiesis-stimulating agents.


FDA strengthens boxed warnings, ap-proves other safety labeling changes forerythropoiesis-stimulating agents (ESAs) [press release]. FDA News 2007 Nov 8.