非格司亭

非格司亭（Filgrastim）是一種治療嗜中性白血球低下的藥物^[21]。造成嗜中性白血球低下的病因包括：愛滋病患者、化學療法或放射治療後，或原因不明^[21]。也可以用進行白血球分離術（英語：Leukapheresis）前，先用此藥可以增加白血球的數量，增加效率^[21]。可靜脈注射或皮下注射給藥^[21]。

非格司亭

臨床資料
商品名（英語：Drug nomenclature）	Neupogen, others
其他名稱	XM02
生物相似藥	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
核准狀況	美 DailyMed: Filgrastim
懷孕分級	澳: B3 [15]
給藥途徑	靜脈注射、皮下注射
藥物類別（英語：Drug class）	造血因子、集落刺激因子
ATC碼	L03AA02 (WHO)
法律規範狀態
法律規範	加：處方藥（℞-only）/ Schedule D[16] 歐：Rx-only[7] 英：處方藥（℞-only） (POM)[17][18][19] 美：處方藥（℞-only）[20]
識別資訊
IUPAC命名法 Human granulocyte colony stimulating factor
CAS號	121181-53-1
IUPHAR/BPS	6968
DrugBank	DB00099
ChemSpider	none
UNII	PVI5M0M1GW
KEGG	D03235
ChEMBL	ChEMBL1201567
ECHA InfoCard	100.167.401
化學資訊
化學式	C845H1343N223O243S9
摩爾質量	18,802.90 g·mol−1

常見副作用包括發燒、咳嗽、胸痛、關節痛、嘔吐和脫髮^[21]。嚴重副作用包括脾臟受傷（英語：Splenic injury）和過敏^[21]。懷孕期使用對胎兒的安全仍不清楚^[21]。非格司亭是天然存在的白血球生長激素（英語：Granulocyte colony-stimulating factor），以重組 DNA 方式製造^[21]。它會刺激身體增加中性粒細胞的數量^[21]。

非格司亭於 1991 年在美國取得醫療使用許可^[21]。名列世界衛生組織基本藥物標準清單^[22]。在美國，已有生物仿製藥^[21]。

參考文獻

1. Drug Approval Package: Nivestym (filgrastim-aafi). U.S. Food and Drug Administration (FDA). 21 February 2019 [20 December 2019]. （原始內容存檔於20 December 2019）.
2. Releuko- filgrastim injection, solution. DailyMed. 11 March 2022 [16 March 2022]. （原始內容存檔於17 March 2022）.
3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761126s000lbl.pdf ^[裸網址]
4. Accofil EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始內容存檔於23 March 2020）.
5. Biograstim EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始內容存檔於22 October 2020）.
6. Grastofil EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始內容存檔於12 November 2020）.
7. Nivestim EPAR. European Medicines Agency (EMA). 17 September 2018 [20 December 2019]. （原始內容存檔於20 December 2019）.
8. Summary Basis of Decision (SBD) for Nivestym. Health Canada. 23 October 2014 [29 May 2022]. （原始內容存檔於30 May 2022）.
9. Summary Basis of Decision (SBD) for Nypozi. Health Canada. 23 October 2014 [29 May 2022]. （原始內容存檔於25 September 2022）.
10. Ratiograstim EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始內容存檔於14 August 2020）.
11. Tevagrastim EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. （原始內容存檔於16 October 2019）.
12. FDA approves first biosimilar product Zarxio. U.S. Food and Drug Administration (FDA) (新聞稿). 6 March 2015 [23 November 2015]. （原始內容存檔於11 December 2015）.
13. Zarxio (filgrastim-sndz). U.S. Food and Drug Administration (FDA). 20 April 2015 [20 December 2019]. （原始內容存檔於20 December 2019）.
14. Zarzio EPAR. European Medicines Agency (EMA). 17 September 2018 [20 December 2019]. （原始內容存檔於15 October 2019）.
15. Filgrastim Use During Pregnancy. Drugs.com. 13 September 2018 [17 December 2019]. （原始內容存檔於18 December 2019）.
16. Health product highlights 2021: Annexes of products approved in 2021. Health Canada. 3 August 2022 [25 March 2024].
17. Neupogen 30 MU (0.3 mg/ml) solution for injection - Summary of Product Characteristics (SmPC). (emc). 7 May 2021 [1 March 2022]. （原始內容存檔於1 March 2022）.
18. 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]. （原始內容存檔於20 December 2019）.
19. Nivestim 12 MU/ 0.2 ml solution for injection/infusion - Summary of Product Characteristics (SmPC). (emc). 18 December 2019 [20 December 2019]. （原始內容存檔於20 December 2019）.
20. Neupogen- filgrastim injection, solution. DailyMed. 15 November 2019 [20 December 2019]. （原始內容存檔於25 November 2020）.
21. Filgrastim. The American Society of Health-System Pharmacists. [8 December 2016]. （原始內容存檔於10 May 2017）.
22. World Health Organization. World Health Organization model list of essential medicines: 21st list 2019. World Health Organization (WHO). 2019. hdl:10665/325771.