摘要
Pegfilgrastim-jmdb是培非格司亭的第1种生物仿制药。2018年6月4日,美国食品药品监督管理局批准Mylan公司研发的pegfilgrastim-jmdb (商品名:Fulphila)上市。Pegfilgrastim-jmdb与靶细胞膜受体结合,产生粒细胞集落刺激因子,刺激粒细胞造血,用来降低非骨髓瘤患者骨髓抑制治疗中发热性中性粒细胞减少症的发生率。本文就pegfilgrastim-jmdb的作用机制、药动学、药物相互作用、临床试验及安全性等信息做一综述,以期为临床用药提供参考。
Pegfilgrastim-jmdb is the first approved biogenerics drug of pegfilgrastim, US Food and Drug Administration approves the listing of Mylan company Fulphila on June 4, 2018. Pegfilgrastim-jmdb binds to target cell membrane receptor to produce granulocyte colony stimulating factor to stimulate granulocyte hematopoiesis, which is used to reduce the incidence of febrile neutropenia in the treatment of myelosuppressive in non-myeloid cancer patients. This paper reviews the mechanism of action, pharmacokinetics, drug interactions, clinical trials and safety of pegfilgrastim-jmdb for clinical treatment.
作者
李少强
封宇飞
胡欣
LI Shao-qiang;EENG Yu-fei;HU Xin(Department of Pharmacy,National Center of Gerontology, Beijing Hospital, Assessment of Clinical Drugs Risk and Indiiidual Appiication Key Laboratory, Beijing 100730,China;Department of Pharmacy Administration and Clinical Pharmacy,School of Pharmaceutical Science,Peking University, Beijing 100191,China;Department of Pharmacy, Peking University People's Hospital, Beijing 100044,China)
出处
《临床药物治疗杂志》
2019年第3期6-9,共4页
Clinical Medication Journal
