LTC Bulletin Board - July 2011: Page 3 of 5

July 22, 2011

FDA Modifies Dosing for Treating Chronic Kidney Disease

On June 24, 2011, the FDA announced more conservative dosing guidelines for erythropoiesis-stimulating agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD), eliminating the concept of a target hemoglobin range of 10 g/dL to 12 g/dL. In addition, the prescribing information and boxed warning will now differentiate between dosing strategies for patients receiving and not receiving dialysis.

Modified language to the prescribing information and boxed warning is being added to reflect the results from clinical trials, including TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy), which showed that using ESAs to target hemoglobin levels of ≥11 g/dL increased the risk of serious and adverse cardiovascular events and provided no additional benefit to patients.

In the new guidelines, the FDA advises physicians to start ESA treatment in patients on dialysis when their hemoglobin level is <10 g/dL, and to reduce or interrupt the dose once their hemoglobin level approaches or exceeds 11 g/dL. For those not on dialysis, the FDA recommends starting ESA therapy when their hemoglobin level is <10 g/dL and the risk for red blood cell transfusion is high, and reducing or interrupting the dose when their hemoglobin level is >10 g/dL.

“The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions,” said John Jenkins, MD, director, Office of New Drugs, Center for Drug Evaluation and Research, in an FDA statement.

The FDA will continue to evaluate the safety of ESAs and is requiring their manufacturer, Amgen Inc., to conduct additional trials. It is also approving modifications to the existing Risk Evaluation and Mitigation Strategy for these agents.