Title: Anaphylaxis and Hypotension after Administration of Peginesatide
Abstract: Anaphylaxis and Hypotension after Administration of PeginesatideTo the Editor: Anemia in patients who have chronic kidney disease and are undergoing dialysis is treated with erythropoiesis-stimulating agents (ESAs). 1 In 2012, the Food and Drug Administration approved peginesatide, an ESA that is administered monthly to such patients. 2,3 In July 2012, a large dialysis organization with 2100 centers in the United States initiated a pilot introduction of peginesatide that included concurrent evaluation of the efficacy and safety of peginesatide and the logistics of administering it.Work groups established systems for evaluating clinical conditions, dosages of the drug, logistics of administration, and review of the efficacy and safety of the product.Personnel at each site were educated about the mechanism of action, pharmacokinetics, storage, handling, and dosing of the drug.The manufacturer provided site specialists.Although registration trials revealed no new toxic effects, by September, eight cases of anaphylaxis and hypotension among patients in the pilot initiative were reported, including two deaths from cardiorespiratory causes and three grade 4 anaphylaxis and hypotension events.In December 2012, the man-