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PubMed · 9622209

Clinical experience with recombinant factor VIIa.

J Lusher·J Ingerslev·H Roberts·U Hedner
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Abstract

Recombinant factor VIIa (rFVIIa) represents a major therapeutic advance in the treatment of haemophilia patients with inhibitors. The efficacy and safety of rFVIIa has been extensively studied in over 1900 surgical and non-surgical bleeding episodes in over 400 patients with haemophilia A or B (with or without inhibitors) or acquired haemophilia. Of 103 evaluable surgical bleeding episodes, the response to treatment with rFVIIa was considered to be either excellent or effective in 81%, 86% and 92% of major, minor and dental bleeding episodes, respectively. Treatment has been evaluated in 518 serious bleeding episodes and the response was considered either excellent or effective in 62% of muscle, 80% of ear, nose and throat, 88% of central nervous system, 76% of joint, and 75% of internal or retroperitoneal bleeding episodes. An excellent safety profile has also been demonstrated: of 1957 treatments with rFVIIa, only 16 serious adverse events have been reported that were considered to be possibly, but not necessarily, related to treatment.

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Clinical Trials as TopicDose-Response Relationship, DrugDrug MonitoringFactor VIIaHemophilia AHemophilia BHumansRecombinant ProteinsJournal ArticleResearch Support, Non-U.S. Gov't

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J Lusher, J Ingerslev, H Roberts, U Hedner. 1998. Clinical experience with recombinant factor VIIa.. https://doi.org/10.1097/00001721-199803000-00002

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