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• W2725706622 abstract "This chapter describes the launch of rFVIIa after approval in EU in 1996, first in France. The interest from the clinicians was high and the sales of rFVIIa increased by 40% per year in the first years. After approval in the United States in 1999, it increased by 63%. Soon after the approval, rFVIIa was successfully used in patients with Glanzmann’s thrombasthenia and was registered for this indication in 2004 in EU. Furthermore, a hemostatic effect in patients with liver disease was seen, but the indication was never pursued. It was, however, used in heavily bleeding patients with a basically normal hemostatic mechanism and later in heavily traumatized patients. One placebo-controlled, randomized, double-blind study showed no side effects and indicated a lower transfusion requirement in the rFVIIa-treated group. A larger study was not pursued. A number of case stories of survival in heavily traumatized patients (terrorist attacks) were published. Finally, rFVIIa (20 µg/kg) was shown to decrease the expansion of intracerebral bleedings without any increase in thromboembolic side effects. In patients receiving a dose of 80 µg/kg, an increased number of arterial thromboembolic side effects (9% vs 4% in the placebo group) were observed." @default.
• W2725706622 created "2017-07-14" @default.
• W2725706622 creator A5085813098 @default.
• W2725706622 date "2017-01-01" @default.
• W2725706622 modified "2023-09-23" @default.
• W2725706622 title "The Launching and Uses of rFVIIa" @default.
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• W2725706622 doi "https://doi.org/10.1016/b978-0-12-812439-0.00008-3" @default.
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