...for use in the United States to reflect the most current data on the risks and benefits of Epoetin alfa therapy. These updates for patients with CRF included information on the Hb range, safety, health-related quality of life (HRQoL), and hyporesponse to therapy. This update in the prescribing information was based on thorough review of safety and outcomes data conducted in September 2007 by a joint meeting of the FDA's Cardio-Renal Drug Advisory Committee (CRDAC) and Drug Safety and Risk Management Advisory Committee (DSRMAC). This article provides an overview of the changes in the Epoetin alfa prescribing information for patients with CRF, and the implications for nephrology nurses and patient care.

FDA Joint Advisory Committees On Use of Epoetin alia in Patients with CRF

The joint meeting of the CRDAC and DSRMAC convened to discuss the risks and benefits of Epoetin alfa in the treatment of the anemia of CRE This re-analysis of data was prompted by safety concerns arising from the results of clinical studies such as the Normal Hematocrit Cardiac Trial (NHCT) (Besarab et al., 1998) and the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study (Singh et al., 2006). The results of these trials suggested an increased risk for death and serious cardiovascular events when Epoetin alfa was administered to achieve higher target Hb levels of 13.,5 and 14.0 g/dL (similar to the boxed warning), and raised concerns regarding both the target Hb level and the potential benefits of therapy in patients with CRE

The interdisciplinary committees also reviewed the historical treatment of the anemia of CRF, including blood transfusions and androgens; the negative effect of these interventions; and the beneficial impact of Epoetin alfa in ameliorating both the anemia of CRF and the need for these therapies. Though not a primary focus of the meeting, the committee also expressed a great deal of interest in research on the associations between Epoetin alfa, improved Hb, and HRQoL.

Revised Epoetin alfa Prescribing Information

On November 8, 2007 the FDA issued the revised prescribing information for use of Epoetin alfa in the United States. These revisions were consistent with the recommendations of the joint CRDAC/DSRMAC committee, and addressed five major topics: (a) Hb range, (b) safety warnings, (c) benefits of Epoetin alfa therapy in patients with CRF, (d) dosing recommendations, and (e) how to define and manage hyporesponse to Epoetin alfa therapy.

Hemoglobin Range

The revised prescribing information recommends that patients should achieve and maintain Hb levels within the range of 10 to 12 g/dL. This is a significant change from the March 2007 prescribing information revision that...

NOTE: All illustrations and photos have been removed from this article.



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