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Amgen Announces Modifications to U.S. Prescribing Information for Use of Erythropoiesis-Stimulating Agents in Chronic Kidney Disease
Date:6/24/2011

THOUSAND OAKS, Calif., June 24, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has approved modified language in the prescribing information for the use of erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa), in patients with chronic kidney disease (CKD). The modified language, including changes to the Boxed Warning, provides important new information for the treatment of patients with CKD who are on dialysis, as well as those not on dialysis, to inform prescribers and patients of safety risks that have been identified in clinical trials.  In recognition of the different benefit-risk profiles of ESA therapy in patients on dialysis compared to patients not on dialysis, the modified labeling provides separate treatment guidance for these two CKD populations.

Specifically, for patients on dialysis, the label advises physicians to initiate ESA therapy when the hemoglobin level is less than 10 g/dL and guides physicians to reduce or interrupt the dose when the hemoglobin approaches or exceeds 11 g/dL. For patients not on dialysis, physicians are asked to consider initiating ESA therapy when the hemoglobin level is below 10 g/dL, when reducing red blood cell transfusion-related risks is a clinical goal and when the rate of hemoglobin decline suggests a transfusion will be likely. Further, for those not on dialysis, physicians should reduce or interrupt the dose when the hemoglobin exceeds 10 g/dL. This guidance replaces the previous label language specifying a hemoglobin target range of 10-12 g/dL for both populations. The modified prescribing information continues to recognize the benefit of reducing the need for transfusions in CKD patients.

In addition, the Boxed Warning, Warnings and Precautions and Clinical Studies sections have been modified
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