非格司亭
 | |
| 临床资料 | |
|---|---|
| 商品名 | Neupogen, others |
| 其他名称 | XM02 |
| 生物相似药 | filgrastim-aafi,[1] filgrastim-ayow,[2] filgrastim-sndz, filgrastim-txid[3] Accofil,[4] Biograstim,[5] Fraven, Grastofil,[6] Nivestim,[7] Nivestym,[8] Nypozi,[3][9] Ratiograstim,[10][11] Releuko,[2] Tevagrastim, Zarxio,[12][13] Zarzio[14] |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a692033 |
| 核准状况 | |
| 怀孕分级 | |
| 给药途径 | 静脉注射、皮下注射 |
| 药物类别 | 造血因子、集落刺激因子 |
| ATC码 | |
| 法律规范状态 | |
| 法律规范 |
|
| 识别信息 | |
| |
| CAS号 | 121181-53-1 |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| ChEMBL | |
| ECHA InfoCard | 100.167.401 |
| 化学信息 | |
| 化学式 | C845H1343N223O243S9 |
| 摩尔质量 | 18,802.90 g·mol−1 |
非格司亭（Filgrastim）是一种治疗嗜中性白血球低下的药物[21]。造成嗜中性白血球低下的病因包括：艾滋病患者、化学疗法或放射治疗后，或原因不明[21]。也可以用进行白血球分离术前，先用此药可以增加白血球的数量，增加效率[21]。可静脉注射或皮下注射给药[21]。
常见副作用包括发烧、咳嗽、胸痛、关节痛、呕吐和脱发[21]。严重副作用包括脾脏受伤和过敏[21]。怀孕期使用对胎儿的安全仍不清楚[21]。非格司亭是天然存在的白血球生长激素，以重组 DNA 方式制造[21]。它会刺激身体增加中性粒细胞的数量[21]。
非格司亭于 1991 年在美国取得医疗使用许可[21]。名列世界卫生组织基本药物标准清单[22]。在美国，已有生物仿制药[21]。
参考文献
- ^ Drug Approval Package: Nivestym (filgrastim-aafi). U.S. Food and Drug Administration (FDA). 21 February 2019 [20 December 2019]. （原始内容存档于20 December 2019）.
- ^ 2.0 2.1 Releuko- filgrastim injection, solution. DailyMed. 11 March 2022 [16 March 2022]. （原始内容存档于17 March 2022）.
- ^ 3.0 3.1 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761126s000lbl.pdf [裸网址]
- ^ Accofil EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始内容存档于23 March 2020）.
- ^ Biograstim EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始内容存档于22 October 2020）.
- ^ Grastofil EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始内容存档于12 November 2020）.
- ^ 7.0 7.1 Nivestim EPAR. European Medicines Agency (EMA). 17 September 2018 [20 December 2019]. （原始内容存档于20 December 2019）.
- ^ Summary Basis of Decision (SBD) for Nivestym. Health Canada. 23 October 2014 [29 May 2022]. （原始内容存档于30 May 2022）.
- ^ Summary Basis of Decision (SBD) for Nypozi. Health Canada. 23 October 2014 [29 May 2022]. （原始内容存档于25 September 2022）.
- ^ Ratiograstim EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始内容存档于14 August 2020）.
- ^ Tevagrastim EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始内容存档于16 October 2019）.
- ^ FDA approves first biosimilar product Zarxio. U.S. Food and Drug Administration (FDA) (新闻稿). 6 March 2015 [23 November 2015]. （原始内容存档于11 December 2015）.
- ^ Zarxio (filgrastim-sndz). U.S. Food and Drug Administration (FDA). 20 April 2015 [20 December 2019]. （原始内容存档于20 December 2019）.
- ^ Zarzio EPAR. European Medicines Agency (EMA). 17 September 2018 [20 December 2019]. （原始内容存档于15 October 2019）.
- ^ Filgrastim Use During Pregnancy. Drugs.com. 13 September 2018 [17 December 2019]. （原始内容存档于18 December 2019）.
- ^ Health product highlights 2021: Annexes of products approved in 2021. Health Canada. 3 August 2022 [25 March 2024].
- ^ Neupogen 30 MU (0.3 mg/ml) solution for injection - Summary of Product Characteristics (SmPC). (emc). 7 May 2021 [1 March 2022]. （原始内容存档于1 March 2022）.
- ^ Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe - Summary of Product Characteristics (SmPC). (emc). 4 July 2019 [20 December 2019]. （原始内容存档于20 December 2019）.
- ^ Nivestim 12 MU/ 0.2 ml solution for injection/infusion - Summary of Product Characteristics (SmPC). (emc). 18 December 2019 [20 December 2019]. （原始内容存档于20 December 2019）.
- ^ Neupogen- filgrastim injection, solution. DailyMed. 15 November 2019 [20 December 2019]. （原始内容存档于25 November 2020）.
- ^ 21.00 21.01 21.02 21.03 21.04 21.05 21.06 21.07 21.08 21.09 21.10 Filgrastim. The American Society of Health-System Pharmacists. [8 December 2016]. （原始内容存档于10 May 2017）.
- ^ World Health Organization. World Health Organization model list of essential medicines: 21st list 2019. World Health Organization (WHO). 2019. hdl:10665/325771.
