Therapeutic Research

Abstract

Objective：This special investigation was conducted under the actual status of the usage to evaluate safety and efficacy of epoetin kappa（Epoetin alfa BS Inj. “JCR”，JCR Pharmaceuticals Co., Ltd., Ashiya）, the first biosimilar product; approved in Japan for renal anemia patients on hemodialysis. Methods：The renal anemia patients on hemodialysis treated with epoetin kappa from October 2010 to December 2011 were observed for 80 weeks or until dropout. Informed consent was obtained from all patients observed. Results：Of the 570 patients evaluated for safety, 6.84％ of patients （39 patients, 75events） experienced adverse drug reactions（ ADRs）. The major ADRs（ more than 0.50％） include bronchitis, blood pressure increased, shunt occlusion （four events, respectively）, nasopharyngitis, hypertension（ three events, respectively）. The incidence of serious ADRs was 2.28％ （13 patients, 18 events）. Of the 548 patients evaluated for efficacy,76.8％ of patients were evaluated as effective by the doctors at the point of final evaluation. Conclusions：As a result of this special investigation with renal anemia patients on hemodialysis, epoetin kappa was confirmed to be safe and effective as the innovator drug, epoetin alfa.