聚乙二醇非格司亭
臨床資料 | |
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商品名 | Neulasta |
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.com | Monograph |
MedlinePlus | a607058 |
核准狀況 |
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懷孕分級 | |
给药途径 | 皮下注射 |
藥物類別 | 造血因子、集落刺激因子、免疫刺激劑 |
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 |
识别信息 | |
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CAS号 | 208265-92-3 |
IUPHAR/BPS | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
ChEMBL | |
ECHA InfoCard | 100.169.155 |
化学信息 | |
化学式 | C845H1343N223O243S9 |
摩尔质量 | 18,802.90 g·mol−1 |
聚乙二醇非格司亭(Pegfilgrastim)又譯為培非格司亭,用于治疗化学疗法或放射治療後造成的嗜中性白血球低下[19] [20]。作用与非格司亭相似,但藥效較長,無需频繁地给药[19]。此药物由皮下注射給藥[21]。
常见副作用包括骨痛[21]。其他副作用包括可能脾臟受傷、急性呼吸窘迫症候群和严重过敏反应[19]。它是非格司亭的聚乙二醇化後的藥物,而非格司亭是一种由基因重组製造的白血球生長激素(GCSF)[20]。它會使骨髓內的白血球增生[21]。
培非格司亭于 2002 年在美国、欧洲和澳大利亚获准用于医疗用途[19] [21] [22]。它被列入世界卫生组织基本药物标准清单[23]。已有生物相似藥上市,价格約為原廠的六至七成[24] [25]。
参考文獻
- ^ 1.0 1.1 Cegfila EPAR. European Medicines Agency (EMA). [2 April 2020]. (原始内容存档于11 June 2020).
- ^ 2.0 2.1 2.2 Filpegla | Therapeutic Goods Administration (TGA). [18 December 2022]. (原始内容存档于18 December 2022).
- ^ 3.0 3.1 Fulphila EPAR. European Medicines Agency (EMA). 24 September 2018 [2 April 2020]. (原始内容存档于11 June 2020).
- ^ 4.0 4.1 Fylnetra- pegfilgrastim injection. DailyMed. 26 May 2022 [19 June 2022]. (原始内容存档于3 July 2022).
- ^ 5.0 5.1 Grasustek EPAR. European Medicines Agency (EMA). 24 April 2019 [2 April 2020]. (原始内容存档于11 June 2020).
- ^ 6.0 6.1 Summary Basis of Decision for Niopeg. Drug and Health Products Portal. 1 September 2012 [17 December 2024].
- ^ 7.0 7.1 Pelmeg EPAR. European Medicines Agency (EMA). 24 September 2018 [2 April 2020]. (原始内容存档于11 June 2020).
- ^ 8.0 8.1 Stimufend- pegflilgrastim-fpgk injection, solution. DailyMed. 15 September 2022 [21 January 2023]. (原始内容存档于21 January 2023).
- ^ 9.0 9.1 Stimufend EPAR. European Medicines Agency (EMA). [4 April 2022]. (原始内容存档于21 April 2022).
- ^ Tezmota. NPS MedicineWise. 15 July 2021 [19 February 2022]. (原始内容存档于29 September 2022).
- ^ 11.0 11.1 Ziextenzo EPAR. European Medicines Agency (EMA). 24 September 2018 [2 April 2020]. (原始内容存档于11 June 2020).
- ^ Summary Basis of Decision (SBD) for Ziextenzo. Health Canada. 23 October 2014 [29 May 2022]. (原始内容存档于30 May 2022).
- ^ 13.0 13.1 Ziextenzo. Therapeutic Goods Administration (TGA). 13 December 2019 [25 August 2020]. (原始内容存档于20 October 2021).
- ^ Pegfilgrastim Use During Pregnancy. Drugs.com. 9 December 2019 [13 July 2020]. (原始内容存档于5 December 2020).
- ^ Neulasta Pre-Filled Syringe - Summary of Product Characteristics (SmPC). (emc). 1 June 2021 [11 October 2021]. (原始内容存档于15 January 2021).
- ^ Neulasta On Body Injector - Summary of Product Characteristics (SmPC). (emc). [11 October 2021]. (原始内容存档于17 January 2021).
- ^ Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection. DailyMed. [14 July 2021]. (原始内容存档于15 July 2021).
- ^ Neulasta EPAR. European Medicines Agency (EMA). 17 September 2018 [2 April 2020]. (原始内容存档于11 June 2020).
- ^ 19.0 19.1 19.2 19.3 Pegfilgrastim Monograph for Professionals. Drugs.com. 22 August 2019 [11 June 2020]. (原始内容存档于7 March 2016).
- ^ 20.0 20.1 Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection. DailyMed. [14 July 2021]. (原始内容存档于15 July 2021).
- ^ 21.0 21.1 21.2 21.3 Neulasta EPAR. European Medicines Agency (EMA). [2 April 2020]. (原始内容存档于11 June 2020).
- ^ NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield. [27 October 2021].
- ^ 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.
- ^ Pegfilgrastim Prices, Coupons & Savings Tips - GoodRx. GoodRx.
- ^ Pegfilgrastim-Bmez Prices, Coupons & Savings Tips - GoodRx. GoodRx. [27 October 2021].