Optimization of dosing regimen for MIRCERA<sup>®</sup> (Epoetin beta pegol) based on pharmacokinetic properties

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  • Nakai Kiyohiko
    Clinical Research Planning Dept. Chugai Pharmaceutical Co., Ltd.

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Other Title
  • 薬物動態学的特性に基づくミルセラ<sup>®</sup>（エポエチンベータ　ペゴル）の用法・用量の設定
  • DDS製品開発の最前線(29)薬物動態学的特性に基づくミルセラ(エポエチンベータ ペゴル)の用法・用量の設定
  • DDS セイヒン カイハツ ノ サイゼンセン(29)ヤクブツ ドウタイガクテキ トクセイ ニ モトズク ミルセラ(エポエチンベータ ペゴル)ノ ヨウホウ ・ ヨウリョウ ノ セッテイ
  • Optimization of dosing regimen for MIRCERA<sup>&reg;</sup> (Epoetin beta pegol) based on pharmacokinetic properties

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Description

Epoetin beta pegol (MIRCERA®) is an erythropoiesis stimulating agent created by integrating a 30kDa methoxy polyethylene glycol (PEG) polymer chain into the erythropoietin (EPO) molecule.Half-life of MIRCERA® in blood was 168-217 hours (mean) in clinical pharmacology study for Japanese hemodialysis patients. This result showed that MIRCERA® was maintained in blood for longer time than the existing recombinant human erythropoietin (rHuEPO) agents (7.5 hours for half-life of epoetin alpha, 9.99 hours for half-life of epoetin beta) and darbepoetin alpha(half-life: 34.54 hours). Based on this pharmacokinetic property, MIRCERA® was thought to be able to treat renal anemia by longer dosage interval than the existing rHuEPO agnets. Both half-lives of MIRCERA® in blood after intravenous and subcutaneous administration were approximately 200 hours which were similar between routes of administration, the drug concentration-time profiles in terminal phase were similar between routes of administration too. Based on this similar sustainability in blood between routes of administration, the unity regimen between intravenous and subcutaneous administration which was impossible for the existing rHuEPO agents was thought be able to be set. To confirm the longer dosage interval and the unity regimen between routes of administration, Phase II and III clinical studies for Japanese chronic kidney disease patients were conducted. The results of these clinical studies showed that MIRCERA® was able to treat renal anemia by longer dosage interval which was two weeks for correction period and four weeks for maintenance period. The results also showed that MIRCERA® was able to treat renal anemia by the unity regimen for intravenous and subcutaneous administration routes. Overall, the launch of MIRCERA® which takes advantage of the technology of drug delivery system in integrating PEG to EPO makes it possible to treat renal anemia by the longer dosage interval and the unity regimen between routes of administration, these features contribute to the convenience and the reduction of incidence for both patients and healthcare professionals.

Journal

  • Drug Delivery System

    Drug Delivery System 30 (2), 139-144, 2015

    THE JAPAN SOCIETY OF DRUG DELIVERY SYSTEM

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