有關WinRho® SDF(Rho(D)人類免疫球蛋白注射劑)安全性的最新資訊 Latest safety update on WinRho® SDF(Rho(D) Immune Globulin Intravenous (Human))

    Cangene Corporation與美國食物及藥物管理局(USFDA)通知衛生專業人士, 過去有數宗關於免疫性血小板減少性紫癜(immune thrombocytopenic purpura, ITP)的病人在使用WinRho® SDF(Rho(D)人類免疫球蛋白注射劑)後出現血管內溶血(intravascular hemolysis, IVH)及併發症的報告, 當中包括致死個案。IVH可引致貧血和多器官衰竭, 包括急性呼吸宭迫綜合症。其他曾報告的嚴重不良反應包括嚴重貧血﹑急性腎功能不全﹑腎衰竭以及彌漫血管內凝血。在出現IVH的病人中, 致命個案多發生於併有其他疾病的年長病人(大於65歲)。因此, Cangene Corporation與USFDA對衛生專業人士作出下述建議:

  • 病人於注射上述藥物後, 需於具有相應設備的醫療機構內密切監視最少8小時。
  • 在注射後2小時﹑4小時以及監視期結束前, 需使用尿液試紙進行分析。
  • 應提醒病人注意IVH的症狀, 包括背痛﹑寒戰﹑尿液變色或血尿。即使於8小時內沒有出現這些症狀, 也不表示隨後並不會發生IVH。
  • 如果於注射WinRho® SDF後出現了IVH的症狀, 或者懷疑出現相關症狀, 便需要進行實驗室檢驗, 包括血漿血紅蛋白﹑尿液分析﹑結合珠蛋白﹑乳酸脫氫酶(LDH)以及血漿膽紅素。

 

    Cangene Corporation and United States Food and Drug Administration(USFDA) notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho® SDF(Rho(D) Immune Globulin Intravenous (Human)). IVH can lead to anemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation have also been reported. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (age over 65) with co-morbid conditions. Therefore, Cangene Corporation and USFDA informed healthcare professionals that:

  • Patients should be closely monitored in a health care setting for at least eight hours after administration.
  • A dipstick urinalysis should be performed at baseline, 2 hours, 4 hours after administration and prior to the end of the monitoring period.
  • Patients should be alerted to and monitor for signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently.
  • If signs and/or symptoms of IVH are present or if IVH is suspected after WinRho® administration, post-treatment laboratory tests should be performed including plasma hemoglobin, urinalysis, haptoglobin, LDH and plasma bilirubin.

   

參考資料/References:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203739.htm

https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM198725.pdf


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