新規 DIC 治療薬リコモジュリン<sup>®</sup>の安全対策

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タイトル別名
  • Risk Management for Recomodulin: With Special Reference to All-Case Surveillance
  • ―全例調査方式の使用成績調査を中心に―

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Recomodulin® Inj. 12800 (thrombomodulin alfa) was first approved in Japan for the treatment of disseminated intravascular coagulation (DIC). For marketing of Recomodulin, we designed post-marketing surveillance and safety measures with the aim to confirm proper use of the product and to ensure patient safety, according to the ICH E2E Guideline on Risk Management Plan (RMP), which was released by the Ministry of Health, Labour and Welfare. Following the RMP, we first selected safety specifications (SS) according to the results of clinical studies. For the SS chosen, all-case surveillance was designed as a pharmacovigilance plan (PVP), and strict control of both patient selection and product distribution was undertaken as a risk minimization action plan (RiskMAP). After launching of Recomodulin, we evaluated the information from all-case surveillance periodically. The safety measures were adjusted accordingly, taking into consideration the advice received from the Recomodulin Post-Marketing Surveillance Committee of the Japanese Society on Thrombosis and Hemostasis, as well as the feasibility in the clinical setting. Based on the information from 4260 cases in all-case surveillance, it was possible to identify the safety profile of Recomodulin at the early stage of marketing. In addition, strict control of both patient selection and product distribution was useful in confirming patient safety and ensuring the proper use of Recomodulin early after release on the market. (Jpn J Clin Pharmacol Ther 2013; 44(2): 61-69)

収録刊行物

  • 臨床薬理

    臨床薬理 44 (2), 61-69, 2013

    一般社団法人 日本臨床薬理学会

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