有關沙奎那韋(saquinavir)安全性的最新資訊 Latest safety update on saquinavir

    美國食物及藥物管理局(USFDA)正回顧關於併用沙奎那韋(saquinavir)和利托那韋(ritonavir)對心臟可能產生嚴重不良反應的臨床試驗, 資料顯示併用兩藥可能會引起QT或PR間期延長。QT間期延長會增加出現心律失常的風險, 甚至導致torsades de pointes, PR間期延長可能會造成心臟傳導阻滯, 因此, 請衛生專業人士:

  • 密切留意併用saquinavir與ritonavir的病人是否出現有關的不良反應。
  • 對於有QT間期延長病史﹑罹患心臟傳導系統疾病﹑缺血性心臟病﹑心肌病或潛在的結構性心臟病的病人, 不要使用saquinavir。
  • 對於正在服用可能延長QT或PR間期的藥物, 包括服用第IA類(如奎尼丁(quinidine))或第III類(如胺碘酮(amiodarone))抗心律失常藥物的病人, 不要併用saquinavir。

備註:獲准在本澳市場供應saquinavir的藥物包括Fortovase® CapInvirase® Cap/Tab

 

    The U.S. Food and Drug Administration (USFDA) is reviewing clinical trial data about a potentially serious effect on the heart from the use of saquinavir in combination with ritonavir. The data suggest that together the two drugs may affect the electrical activity of the heart, causing prolonged QT or PR intervals. A prolonged QT interval can increase the risk for abnormal heart rhythms, including a serious abnormal rhythm called torsades de pointes. A prolonged PR interval can cause heart block. Therefore, healthcare professionals are recommended:

  • Closely monitor if any adverse drug reaction occurs in patients using saquinavir with ritonavir.
  • Not use saquinavir in patients with a history of QT interval prolongation, preexisting conduction system disease, ischemic heart disease, cardiomyopathy, or underlying structural heart disease. 
  • Not use saquinavir in patients who are currently using Class IA (such as quinidine) or Class III (such as amiodarone) antiarrhythmic drugs or other drugs that may prolong the QT or PR interval.

Note:The saquinavir-containing medications authorized for distribution in the Macao market include Fortovase® Cap and Invirase® Cap/Tab.

 

參考資料/References:

https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201221.htm


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