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德曲妥珠單抗

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德曲妥珠單抗
单克隆抗体
种类完整抗体
目標HER2
臨床資料
商品名英语Drug nomenclatureEnhertu
其他名稱DS-8201a, fam-trastuzumab deruxtecan-nxki
AHFS/Drugs.comMonograph
MedlinePlusa620006
核准狀況
懷孕分級
给药途径靜脈注射
藥物類別化学疗法
ATC碼
法律規範狀態
法律規範
识别信息
CAS号1826843-81-5
PubChem SID
DrugBank
UNII
KEGG
ChEMBL
化学信息
化学式C6460H9972N1724O2014S44.(C52H57F1N9O13)8

德曲妥珠單抗INN:Trastuzumab deruxtecan)全名是曲妥珠单抗ー德鲁替康,用于治疗乳癌胃癌或胃食道腺癌[11] [12]。主要是針對HER2/neu阳性的疾病[11] [12]。透过静脉緩慢注射[13]

常见副作用包括恶心、疲倦、脱发、便秘贫血白细胞减少症血小板減少症和头痛[13]。其他副作用包括可能發生低鉀血症心律不整間質性肺病和肝脏问题[13]。孕期使用可能對婴儿有害[14]。它是由拓撲異構酶1抑製劑英语Topoisomerase inhibitor德鲁替康英语Deruxtecan與它连接的单克隆抗体曲妥珠单抗結合的組合藥物[13]。曲妥珠单抗會与表皮生长因子受体2(HER2/neu)结合,而德鲁替康则會阻断细胞制造脱氧核糖核酸(DNA)的能力[13]

德曲妥珠單抗分別於2019年及2020年在美國[11]及日本[15]取得醫療使用許可 。而欧洲和澳大利亚在2021年取得醫療使用許可[13] [14]

参考文獻

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  1. ^ 1.0 1.1 Enhertu. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. (原始内容存档于23 October 2021). 
  2. ^ Updates to the Prescribing Medicines in Pregnancy database. Therapeutic Goods Administration (TGA). 21 December 2022 [2 January 2023]. (原始内容存档于3 April 2022). 
  3. ^ AusPAR: Trastuzumab deruxtecan. Therapeutic Goods Administration (TGA). 27 June 2022 [17 July 2022]. (原始内容存档于18 July 2022). 
  4. ^ Enhertu (AstraZeneca Pty Ltd). Therapeutic Goods Administration (TGA). 16 February 2023 [9 April 2023]. (原始内容存档于18 March 2023). 
  5. ^ Summary Basis of Decision (SBD) for Enhertu. Health Canada. 23 October 2014 [29 May 2022]. (原始内容存档于30 May 2022). 
  6. ^ Enhertu 100 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC). (emc). 1 July 2022 [1 July 2022]. (原始内容存档于19 April 2021). 
  7. ^ Enhertu- fam-trastuzumab deruxtecan-nxki injection, powder, lyophilized, for solution. DailyMed. [15 January 2021]. (原始内容存档于22 January 2021). 
  8. ^ Enhertu EPAR. European Medicines Agency (EMA). 9 December 2020 [31 March 2021]. (原始内容存档于23 March 2021). 
  9. ^ Enhertu Product information. Union Register of medicinal products. [3 March 2023]. (原始内容存档于5 March 2023). 
  10. ^ Enhertu approved in the EU for the treatment of HER2-positive metastatic breast cancer (新闻稿). AstraZeneca. 20 January 2021 [21 January 2021]. (原始内容存档于20 January 2021). 
  11. ^ 11.0 11.1 11.2 Fam-Trastuzumab Deruxtecan-nxki Monograph for Professionals. Drugs.com. [10 December 2021]. (原始内容存档于27 December 2021) (英语). 
  12. ^ 12.0 12.1 FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas. U.S. Food and Drug Administration (FDA). 15 January 2021 [15 January 2021]. (原始内容存档于15 January 2021).  公有领域 本文含有此來源中屬於公有领域的内容。
  13. ^ 13.0 13.1 13.2 13.3 13.4 13.5 Enhertu EPAR. European Medicines Agency (EMA). 9 December 2020 [31 March 2021]. (原始内容存档于23 March 2021). 
  14. ^ 14.0 14.1 Enhertu. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. (原始内容存档于23 October 2021). 
  15. ^ Enhertu Approved in Japan for Treatment of Patients with HER2 Positive Unresectable or Metastatic Breast Cancer (新闻稿). Daiichi Sankyo. 25 March 2020 [21 January 2021]. (原始内容存档于28 January 2021). 

延伸閱讀

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外部連結

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  • Deruxtecan页面存档备份,存于互联网档案馆) shows structure
  • Clinical trial number NCT03329690 for "DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]" at ClinicalTrials.gov
  • Clinical trial number NCT03529110 for "DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]" at ClinicalTrials.gov