阿伏利尤單抗
| 單株抗體 | |
|---|---|
| 種類 | 完整抗體 |
| 目標 | 第一型干擾素受體 |
| 臨床資料 | |
| 商品名 | Saphnelo |
| 其他名稱 | MEDI-546, anifrolumab-fnia |
| AHFS/Drugs.com | Monograph |
| 核准狀況 | |
| 懷孕分級 | |
| 給藥途徑 | 靜脈注射 |
| 藥物類別 | 第一型干擾素受體阻斷劑 |
| ATC碼 | |
| 法律規範狀態 | |
| 法律規範 |
|
| 識別資訊 | |
| CAS號 | 1326232-46-5 |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| 化學資訊 | |
| 化學式 | C6444H9964N1712O2018S44 |
| 摩爾質量 | 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），用於治療全身性紅斑狼瘡[7]。適用於常規治療無法控制的中度至重度病症[7]。透過靜脈注射給藥[7]。
最常見的副作用是上呼吸道感染和支氣管炎[8]。其他副作用包括可能帶狀疱疹[8]。妊娠期的安全性不明[7]。它是一種單株抗體，與第一型干擾素受體結合，並阻斷第一型干擾素的作用[8]。
阿伏利尤單抗分別於2021年與2022年獲得美國與歐洲的醫療使用許可[7] [8]。美國食品藥品監督管理局將它視為同類新創藥[9]。
命名
[編輯]阿伏利尤單抗是國際非專利名稱 (international nonproprietary name，INN)。[10]
參考文獻
[編輯]- ^ 1.0 1.1 Saphnelo APMDS. Therapeutic Goods Administration (TGA). 12 April 2022 [24 April 2022]. （原始內容存檔於19 September 2022）.
- ^ Updates to the Prescribing Medicines in Pregnancy database. Therapeutic Goods Administration (TGA). 21 December 2022 [2 January 2023].
- ^ Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-01-24]. Health Canada. 24 January 2022 [28 May 2022]. （原始內容存檔於29 May 2022）.
- ^ Summary Basis of Decision (SBD) for Saphnelo. Health Canada. 23 October 2014 [29 May 2022]. （原始內容存檔於29 May 2022）.
- ^ Saphnelo- anifrolumab injection, solution. DailyMed. [11 August 2021]. （原始內容存檔於12 August 2021）.
- ^ Saphnelo EPAR. European Medicines Agency. 16 December 2021 [11 April 2022]. （原始內容存檔於12 April 2022）. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ 7.0 7.1 7.2 7.3 7.4 Saphnelo- anifrolumab injection, solution. DailyMed. [11 August 2021]. （原始內容存檔於12 August 2021）.
- ^ 8.0 8.1 8.2 8.3 Saphnelo EPAR. European Medicines Agency. 16 December 2021 [11 April 2022]. （原始內容存檔於12 April 2022）. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021. U.S. Food and Drug Administration (FDA) (報告). 13 May 2022 [22 January 2023]. （原始內容 (PDF)存檔於6 December 2022）.
- ^ World Health Organization. International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 71. WHO Drug Information. 2014, 28 (1). hdl:10665/331151
.
延伸閱讀
[編輯]- Anderson E, Furie R. 阿伏利尤單抗治療全身性紅斑狼瘡：當前知識和未來考量. Immunotherapy. April 2020, 12 (5): 275–286. PMID 32237942. S2CID 214768375. doi:10.2217/imt-2020-0017.
外部連節
[編輯]- 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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