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The pharmacokinetics and pharmacodynamics of single-dose and multiple-dose recombinant activated factor VII in patients with haemophilia A or B

Haemophilia Sep 02, 2017

Fernández–Bello I, et al. – This study planned to compare the pharmacokinetics (PK) of recombinant activated factor VII (rFVIIa) after 3×90 μg kg-1 doses vs a single dose (270 μg kg-1) in haemophilia patients, as well as to gauge thromboelastography (TEG)/thrombin generation assay (TGA) results postdosing to determine how these assays relate to PK findings. TEG and TGA both supported the PK results, while they were not yet clinically predictive. A single dose of 270 μg kg-1 rFVIIa provided slightly higher haemostatic potential than the multiple–dose regimen of 3×90 μg kg-1. However, in comparison to a higher single dose, the multiple–dose regimen of 3×90 μg kg-1 resulted in prolonged activity levels.
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