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聚乙二醇非格司亭

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聚乙二醇非格司亭
臨床資料
商品名英語Drug nomenclatureNeulasta
生物相似藥pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Cegfila,[1] Filpegla,[2] Fulphila,[3] Fylnetra,[4] Grasustek,[5] Lapelga, Neutropeg, Niopeg,[6] Nyvepria, Pelgraz, Pelmeg,[7] Ristempa, Stimufend,[8][9] Tezmota,[10] Udenyca, Ziextenzo[11][12]
AHFS/Drugs.comMonograph
MedlinePlusa607058
核准狀況
懷孕分級
給藥途徑皮下注射
藥物類別英語Drug class造血因子、集落刺激因子免疫刺激劑英語immunostimulant
ATC碼
法律規範狀態
法律規範
藥物動力學數據
生物半衰期15–80 小時
識別資訊
  • N-(3-Hydroxypropyl)Methionylcolony-stimulating Factor (human), 1-Ether with .Alpha.-Methyl-.Omega.-Hydroxypoly(Oxyethylene)
CAS號208265-92-3  checkY
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
ECHA InfoCard100.169.155 編輯維基數據鏈接
化學資訊
化學式C845H1343N223O243S9
摩爾質量18,802.90 g·mol−1


聚乙二醇非格司亭Pegfilgrastim)又譯為非格司亭,用於治療化學療法放射治療後造成的嗜中性白血球低下[19] [20]。作用與非格司亭相似,但藥效較長,無需頻繁地給藥[19]。此藥物由皮下注射給藥[21]

常見副作用包括骨痛[21]。其他副作用包括可能脾臟受傷英語Splenic injury急性呼吸窘迫症候群嚴重過敏反應[19]。它是非格司亭的聚乙二醇化英語PEGylation化後的藥物,而非格司亭是一種由基因重組製造的白血球生長激素英語Granulocyte colony-stimulating factor(GCSF)[20]。它會使骨髓內的白血球增生[21]

培非格司亭於 2002 年在美國、歐洲和澳大利亞獲准用於醫療用途[19] [21] [22]。它被列入世界衛生組織基本藥物標準清單[23]。已有生物相似藥上市,價格約為原廠的六至七成[24] [25]

參考文獻

  1. ^ 1.0 1.1 Cegfila EPAR. European Medicines Agency (EMA). [2 April 2020]. (原始內容存檔於11 June 2020). 
  2. ^ 2.0 2.1 2.2 Filpegla | Therapeutic Goods Administration (TGA). [18 December 2022]. (原始內容存檔於18 December 2022). 
  3. ^ 3.0 3.1 Fulphila EPAR. European Medicines Agency (EMA). 24 September 2018 [2 April 2020]. (原始內容存檔於11 June 2020). 
  4. ^ 4.0 4.1 Fylnetra- pegfilgrastim injection. DailyMed. 26 May 2022 [19 June 2022]. (原始內容存檔於3 July 2022). 
  5. ^ 5.0 5.1 Grasustek EPAR. European Medicines Agency (EMA). 24 April 2019 [2 April 2020]. (原始內容存檔於11 June 2020). 
  6. ^ 6.0 6.1 Summary Basis of Decision for Niopeg. Drug and Health Products Portal. 1 September 2012 [17 December 2024]. 
  7. ^ 7.0 7.1 Pelmeg EPAR. European Medicines Agency (EMA). 24 September 2018 [2 April 2020]. (原始內容存檔於11 June 2020). 
  8. ^ 8.0 8.1 Stimufend- pegflilgrastim-fpgk injection, solution. DailyMed. 15 September 2022 [21 January 2023]. (原始內容存檔於21 January 2023). 
  9. ^ 9.0 9.1 Stimufend EPAR. European Medicines Agency (EMA). [4 April 2022]. (原始內容存檔於21 April 2022). 
  10. ^ Tezmota. NPS MedicineWise. 15 July 2021 [19 February 2022]. (原始內容存檔於29 September 2022). 
  11. ^ 11.0 11.1 Ziextenzo EPAR. European Medicines Agency (EMA). 24 September 2018 [2 April 2020]. (原始內容存檔於11 June 2020). 
  12. ^ Summary Basis of Decision (SBD) for Ziextenzo. Health Canada. 23 October 2014 [29 May 2022]. (原始內容存檔於30 May 2022). 
  13. ^ 13.0 13.1 Ziextenzo. Therapeutic Goods Administration (TGA). 13 December 2019 [25 August 2020]. (原始內容存檔於20 October 2021). 
  14. ^ Pegfilgrastim Use During Pregnancy. Drugs.com. 9 December 2019 [13 July 2020]. (原始內容存檔於5 December 2020). 
  15. ^ Neulasta Pre-Filled Syringe - Summary of Product Characteristics (SmPC). (emc). 1 June 2021 [11 October 2021]. (原始內容存檔於15 January 2021). 
  16. ^ Neulasta On Body Injector - Summary of Product Characteristics (SmPC). (emc). [11 October 2021]. (原始內容存檔於17 January 2021). 
  17. ^ Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection. DailyMed. [14 July 2021]. (原始內容存檔於15 July 2021). 
  18. ^ Neulasta EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. (原始內容存檔於11 June 2020). 
  19. ^ 19.0 19.1 19.2 19.3 Pegfilgrastim Monograph for Professionals. Drugs.com. 22 August 2019 [11 June 2020]. (原始內容存檔於7 March 2016). 
  20. ^ 20.0 20.1 Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection. DailyMed. [14 July 2021]. (原始內容存檔於15 July 2021). 
  21. ^ 21.0 21.1 21.2 21.3 Neulasta EPAR. European Medicines Agency (EMA). [2 April 2020]. (原始內容存檔於11 June 2020). 
  22. ^ NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield. [27 October 2021]. 
  23. ^ World Health Organization. The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. 2023. WHO/MHP/HPS/EML/2023.02. 
  24. ^ Pegfilgrastim Prices, Coupons & Savings Tips - GoodRx. GoodRx. 
  25. ^ Pegfilgrastim-Bmez Prices, Coupons & Savings Tips - GoodRx. GoodRx. [27 October 2021].