免疫抑制薬の後発医薬品使用に関する一考察

抄録

Ministry of health, labour and welfare of Japan is promoting the use of generic drugs in the DPC (diagnosis procedure combination) hospitals including medical institutions dealing with organ transplantation. Immunosuppressive agents of which blood concentration monitoring is recommended to optimize the individual dose in the transplant recipients are also required to substitute from original bland to generic one, even though their pharmacokinetics are not equal. In this paper, author describes several issues for generic substitution for immunosuppressive agents in the pharmacokinetic points of view. The ESOT (Europian Society Organ Transplantation) guideline for the generic substitution of immunosuppressive agents is also presented to discuss the proper use of the generic drugs for transplant recipients in Japan.