This updated safety review summarises the large body of safety data available on the use of recombinant activated factor VII (rFVIIa) in approved indications: haemophilia with inhibitors, congenital factor VII (FVII) deficiency, acquired haemophilia and Glanzmann's thrombasthenia. Accumulated data up to 31 December 2013 from clinical trials as well as post-marketing data (registries, literature reports and spontaneous reports) were included. Overall, rFVIIa has shown a consistently favourable safety profile, with no unexpected safety concerns, in all approved indications. No confirmed cases of neutralising antibodies against rFVIIa have been reported in patients with congenital haemophilia, acquired haemophilia or Glanzmann's thrombasthenia. The favourable safety profile of rFVIIa can be attributed to the recombinant nature of rFVIIa and its localised mechanism of action at the site of vascular injury. Recombinant FVIIa activates factor X directly on the surface of activated platelets, which are present only at the site of injury, meaning that systemic activation of coagulation is avoided and the risk of thrombotic events (TEs) thus reduced. Nonetheless, close monitoring for signs and symptoms of TE is warranted in all patients treated with any pro-haemostatic agent, including rFVIIa, especially the elderly and any other patients with concomitant conditions and/or predisposing risk factors to thrombosis.

中文翻译：

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在批准的适应症中使用重组激活的因子VII的安全性更新。

这份最新的安全性综述总结了在批准的适应症中使用重组活化因子VII（rFVIIa）可获得的大量安全性数据：带有抑制剂的血友病，先天性因子VII（FVII）缺乏症，获得性血友病和Glanzmann血栓性衰弱。包括截至2013年12月31日的临床试验累积数据以及上市后数据（注册表，文献报告和自发报告）。总体而言，rFVIIa在所有批准的适应症中均显示出始终如一的良好安全性，而没有意外的安全隐患。先天性血友病，获得性血友病或格兰兹曼血栓性衰弱的患者中，尚无针对rFVIIa的中和抗体的确诊病例报告。rFVIIa的良好安全性可归因于rFVIIa的重组性质及其在血管损伤部位的局部作用机制。重组FVIIa直接在仅存在于损伤部位的活化血小板表面上活化因子X，这意味着可以避免系统性的凝血活化，从而降低了血栓形成事件（TEs）的风险。尽管如此，在所有使用止血剂治疗的患者（包括rFVIIa）中，尤其是老年人和任何其他伴有血栓形成危险因素和/或易患危险因素的患者中，都应密切监测TE的体征和症状。它们仅存在于受伤部位，这意味着可以避免系统性的凝血激活，从而降低了血栓形成事件（TEs）的风险。尽管如此，在所有使用止血剂治疗的患者（包括rFVIIa）中，尤其是老年人和任何其他伴有血栓形成危险因素和/或易患危险因素的患者中，都应密切监测TE的体征和症状。它们仅存在于受伤部位，这意味着可以避免系统性的凝血激活，从而降低了血栓形成事件（TEs）的风险。尽管如此，在所有使用止血剂治疗的患者（包括rFVIIa）中，尤其是老年人和任何其他伴有血栓形成危险因素和/或易患危险因素的患者中，都应密切监测TE的体征和症状。