Information for Healthcare Providers

Pure red cell aplasia (PRCA) is a rare condition that has been associated with autoimmune diseases, infections, neoplastic diseases, thymoma and exposure to certain drugs. Antibody-mediated PRCA is a rare to very rare adverse drug reaction in which patients who are treated with erythropoiesis-stimulating agents (ESAs) develop neutralizing antibodies to the ESA. These antibodies inactivate ESAs and naturally produced erythropoietin. The resulting anemia does not respond to treatment with an ESA. Patients with antibody-mediated PRCA need to receive red blood cell transfusions on a regular basis typically over a number of months.

Antibody-mediated PRCA cases have been reported predominantly in patients with chronic renal failure (CRF) receiving ESAs by subcutaneous administration. PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon alfa or pegylated interferon alfa and ribavirin. ESAs are not approved by the U.S. Food and Drug Administration (FDA) for use in patients with HCV.

Identification and Reporting of Pure Red Cell Aplasia (PRCA) and Severe Anemia with Neutralizing Antibodies

Any patient who develops a sudden loss of response to an ESA accompanied by severe anemia should be evaluated for the etiology of loss of effect, including the presence of binding and neutralizing antibody to erythropoietin. If anti-erythropoietin antibody-mediated anemia is suspected, ESA therapy should be withheld. In patients with antibody-mediated anemia, ESA treatment should be permanently discontinued. Patients who develop PRCA should not be switched to other ESAs as antibodies may cross-react. For EPOGEN® and Aranesp®, contact Amgen (1-800-77AMGEN) to perform assays for binding and neutralizing antibodies.

For more information, please visit the EPOGEN and Aranesp web sites and see the U.S. prescribing information for EPOGEN®, and Aranesp®, including WARNINGS, Pure Red Cell Aplasia.

(Updated April 10, 2009)