Pharmacokinetics and safety of a 270 mcg kg−1 dose of room temperature stable recombinant activated factor VII in patients with haemophilia
作者： M. MORFINI , J. BJERRE
DOI: 10.1111/J.1365-2516.2011.02498.X
关键词: Pharmacology 、 Adverse effect 、 Bioequivalence 、 Haemophilia 、 Medicine 、 Anesthesia 、 In patient 、 Haemophilia A 、 Recombinant DNA 、 Recombinant factor VIIa 、 Pharmacokinetics
摘要: Recombinant factor VIIa (rFVIIa), a haemostatic bypassing agent, has been shown to be effective and well-tolerated in patients with haemophilia at standard doses of 90 270 mcg kg(-1). A new room temperature stable formulation rFVIIa was recently developed that bioequivalent maintain the safety efficacy profiles original dose The aim this study examine pharmacokinetics rFVIIa-RT kg(-1) dose. newly formulated room-temperature recombinant activated VII (BHK-rFVIIa-RT) evaluated 23 subjects congenital or B. pharmacokinetic profile for BHK-rFVIIa-RT line what previously observed AUC(last) C(max) (346.65 h IU mL(-1) 146.12 respectively) were proportionally higher than those lower (113.26 52.83 mL(-1)) demonstrating dose-dependent nature activity. There no thromboembolic events related serious adverse reported increased BHK-rFVIIa-RT, withdrew because events. This indicates well tolerated dosage maintains favourable established by rFVIIa. Therefore, shows effects do not appear increase risk
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