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阿伏利尤單抗

维基百科，自由的百科全书
阿伏利尤單抗
单克隆抗体
种类完整抗体
目標第一型干擾素受體（英语：Interferon-alpha/beta receptor）
臨床資料
商品名（英语：Drug nomenclature）Saphnelo
其他名稱MEDI-546, anifrolumab-fnia
AHFS/Drugs.comMonograph
核准狀況
懷孕分級
给药途径靜脈注射
藥物類別（英语：Drug class）第一型干擾素受體（英语：Interferon-alpha/beta receptor）阻斷劑
ATC碼
法律規範狀態
法律規範
识别信息
CAS号1326232-46-5
DrugBank
ChemSpider
  • none
UNII
KEGG
化学信息
化学式C6444H9964N1712O2018S44
摩尔质量145,119.20 g·mol−1

阿伏利尤單抗（英語：Anifrolumab）商品名為莎芙諾（英語：Saphnelo），用于治疗全身性紅斑狼瘡[7]。適用於常规治疗无法控制的中度至重度病症[7]。透過靜脈注射给药[7]。

最常见的副作用是上呼吸道感染和支气管炎[8]。其他副作用包括可能带状疱疹[8]。妊娠期的安全性不明[7]。它是一种单克隆抗体，與第一型干擾素受體（英语：Interferon-alpha/beta receptor）结合，並阻断第一型干擾素（英语：Interferon type I）的作用[8]。

阿伏利尤單抗分別於2021年與2022年获得美国與歐洲的医疗使用許可[7] [8]。美国食品药品监督管理局将它视为同類新創藥（英语：First-in-class medication）[9]。

命名

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阿伏利尤單抗是国际非专利名称 (international nonproprietary name，INN)。[10]

參考文獻

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  1. ^ 1.0 1.1 Saphnelo APMDS. Therapeutic Goods Administration (TGA). 12 April 2022 [24 April 2022]. （原始内容存档于19 September 2022）. 
  2. ^ Updates to the Prescribing Medicines in Pregnancy database. Therapeutic Goods Administration (TGA). 21 December 2022 [2 January 2023]. 
  3. ^ Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-01-24]. Health Canada. 24 January 2022 [28 May 2022]. （原始内容存档于29 May 2022）. 
  4. ^ Summary Basis of Decision (SBD) for Saphnelo. Health Canada. 23 October 2014 [29 May 2022]. （原始内容存档于29 May 2022）. 
  5. ^ Saphnelo- anifrolumab injection, solution. DailyMed. [11 August 2021]. （原始内容存档于12 August 2021）. 
  6. ^ Saphnelo EPAR. European Medicines Agency. 16 December 2021 [11 April 2022]. （原始内容存档于12 April 2022）.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ^ 7.0 7.1 7.2 7.3 7.4 Saphnelo- anifrolumab injection, solution. DailyMed. [11 August 2021]. （原始内容存档于12 August 2021）. 
  8. ^ 8.0 8.1 8.2 8.3 Saphnelo EPAR. European Medicines Agency. 16 December 2021 [11 April 2022]. （原始内容存档于12 April 2022）.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021. U.S. Food and Drug Administration (FDA) (报告). 13 May 2022 [22 January 2023]. （原始内容 (PDF)存档于6 December 2022）. 
  10. ^ World Health Organization. International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 71. WHO Drug Information. 2014, 28 (1). hdl:10665/331151 可免费查阅. 

延伸閱讀

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外部連節

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  • Clinical trial number NCT01438489 for "A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus" at ClinicalTrials.gov
  • Clinical trial number NCT02446912 for "Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus" at ClinicalTrials.gov
  • Clinical trial number NCT02446899 for "Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus" at ClinicalTrials.gov


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