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      Tolerability and Efficacy of Multidose Epoetin Beta (Reco-Pen ®) for Subcutaneous Administration in Patients with Anemia due to Renal Failure

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          Aims: To assess the tolerability, safety and efficacy of the epoetin beta multidose cartridge formulation, self-administered subcutaneously via a pen device (Reco-Pen<sup>®</sup>), in adult patients with renal anemia. Methods: Patients receiving maintenance epoetin therapy were switched to the subcutaneous (SC) multidose formulation of epoetin beta (NeoRecormon<sup>®</sup>). The frequency of adverse events, local tolerability, and changes in blood pressure and laboratory variables were recorded. Hematologic parameters, transfusion requirements and epoetin beta dosage were also assessed. Results: A total of 406 patients were entered in the intention-to-treat analysis. Mean treatment duration was 82.3 days. Fifty patients (12.3%) withdrew from the study; 14 (3.4%) discontinued because of adverse events. Treatment was well tolerated, with adverse events considered probably related to treatment in only 5 cases, and 1 case of local intolerability. There were no clinically significant changes in blood pressure or laboratory variables, and no changes in hematologic parameters or transfusion requirements. Unexpectedly, the epoetin beta dose was reduced by almost one-third in patients previously maintained on SC epoetin. Conclusion: SC administration of this multidose epoetin beta formulation with the Reco-Pen<sup>®</sup> device was well tolerated and effective. It is possible that the improved capacity to individualize dose may have contributed to the considerable reduction in SC epoetin beta dosage requirement.

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          Author and article information

          Kidney Blood Press Res
          Kidney and Blood Pressure Research
          S. Karger AG
          29 July 2003
          : 26
          : 3
          : 192-198
          aGemeinschaftspraxis Karlstrasse, Düsseldorf; bCaritas Krankenhaus, Bad Mergentheim; cKatholisches Krankenhaus Marien-Hospital, Duisburg; dDr. Horst Schmidt-Kliniken, Wiesbaden; eKrankenanstalten Gilead, Bielefeld; fDialysepraxis, Igersheim; gPraxis, Wiesbaden und hKfH am Krankenhaus der Missions-Benediktinerinnen, Tutzing, Deutschland
          71885 Kidney Blood Press Res 2003;26:192–198
          © 2003 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

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          Figures: 1, Tables: 3, References: 30, Pages: 7
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