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德曲妥珠單抗

維基百科，自由的百科全書
德曲妥珠單抗
單株抗體
種類完整抗體
目標HER2
臨床資料
商品名（英語：Drug nomenclature）Enhertu
其他名稱DS-8201a, fam-trastuzumab deruxtecan-nxki
AHFS/Drugs.comMonograph
MedlinePlusa620006
核准狀況
懷孕分級
給藥途徑靜脈注射
藥物類別化學療法
ATC碼
法律規範狀態
法律規範
識別資訊
CAS號1826843-81-5
PubChem SID
DrugBank
UNII
KEGG
ChEMBL
化學資訊
化學式C6460H9972N1724O2014S44.(C52H57F1N9O13)8

德曲妥珠單抗（INN：Trastuzumab deruxtecan）全名是曲妥珠單抗ー德魯替康，用於治療乳癌和胃癌或胃食道腺癌[11] [12]。主要是針對HER2/neu陽性的疾病[11] [12]。透過靜脈緩慢注射[13]。

常見副作用包括噁心、疲倦、脫髮、便秘、貧血、白血球減少症、血小板減少症和頭痛[13]。其他副作用包括可能發生低鉀血症、心律不整、間質性肺病和肝臟問題[13]。孕期使用可能對嬰兒有害[14]。它是由拓撲異構酶1抑製劑（英語：Topoisomerase inhibitor）德魯替康（英語：Deruxtecan）與它連接的單株抗體ー曲妥珠單抗結合的組合藥物[13]。曲妥珠單抗會與表皮生長因子受體2（HER2/neu）結合，而德魯替康則會阻斷細胞製造脫氧核糖核酸（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 。而歐洲和澳大利亞在2021年取得醫療使用許可[13] [14]。

參考文獻

[編輯]
  1. ^ 1.0 1.1 Enhertu. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. （原始內容存檔於23 October 2021）. 
  2. ^ Updates to the Prescribing Medicines in Pregnancy database. Therapeutic Goods Administration (TGA). 21 December 2022 [2 January 2023]. （原始內容存檔於3 April 2022）. 
  3. ^ AusPAR: Trastuzumab deruxtecan. Therapeutic Goods Administration (TGA). 27 June 2022 [17 July 2022]. （原始內容存檔於18 July 2022）. 
  4. ^ Enhertu (AstraZeneca Pty Ltd). Therapeutic Goods Administration (TGA). 16 February 2023 [9 April 2023]. （原始內容存檔於18 March 2023）. 
  5. ^ Summary Basis of Decision (SBD) for Enhertu. Health Canada. 23 October 2014 [29 May 2022]. （原始內容存檔於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]. （原始內容存檔於19 April 2021）. 
  7. ^ Enhertu- fam-trastuzumab deruxtecan-nxki injection, powder, lyophilized, for solution. DailyMed. [15 January 2021]. （原始內容存檔於22 January 2021）. 
  8. ^ Enhertu EPAR. European Medicines Agency (EMA). 9 December 2020 [31 March 2021]. （原始內容存檔於23 March 2021）. 
  9. ^ Enhertu Product information. Union Register of medicinal products. [3 March 2023]. （原始內容存檔於5 March 2023）. 
  10. ^ Enhertu approved in the EU for the treatment of HER2-positive metastatic breast cancer (新聞稿). AstraZeneca. 20 January 2021 [21 January 2021]. （原始內容存檔於20 January 2021）. 
  11. ^ 11.0 11.1 11.2 Fam-Trastuzumab Deruxtecan-nxki Monograph for Professionals. Drugs.com. [10 December 2021]. （原始內容存檔於27 December 2021） （英語）. 
  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]. （原始內容存檔於15 January 2021）.  公有領域 本文含有此來源中屬於公有領域的內容。
  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]. （原始內容存檔於23 March 2021）. 
  14. ^ 14.0 14.1 Enhertu. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. （原始內容存檔於23 October 2021）. 
  15. ^ Enhertu Approved in Japan for Treatment of Patients with HER2 Positive Unresectable or Metastatic Breast Cancer (新聞稿). Daiichi Sankyo. 25 March 2020 [21 January 2021]. （原始內容存檔於28 January 2021）. 

延伸閱讀

[編輯]

外部連結

[編輯]
  • Deruxtecan （頁面存檔備份，存於網際網路檔案館） 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


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