免疫抑制薬の後発医薬品使用:臓器移植領域におけるトピックス

抄録

Generic substitution, even in the immunosuppressant (IM) for organ transplantation, has been accelerating in national health insurance system for Japan. To understand the several issues in the use of generic IM, published papers currently were summarized. Systematic review including meta-analysis for comparing suggested that no difference was found in the adverse events including acute rejection between brand and generic IM used in the early phase post-transplantation. The Pharmacokinetic (PK) data for healthy subjects potentially can be applied to the transplant recipients, even in the data are collected from the study for the single administration. Intensive therapeutic drug monitoring may be required in genetic substitution, especially in the case of mycophenorate mofetil. The safety and intra-individual variation of drug exposure for generic IM should be assessed by the long-term administration and the sophisticated TDM study, respectively, to establish the optimal use for the transplant recipients.