Abstract
The use of human fibrinogen concentrates (HFC) is well established in the prevention and treatment of congenital fibrinogen-related bleeding disorders [1]. An increasing number of studies also recommend HFC for the treatment of haemorrhage in trauma, postpartum haemorrhage, and patients experiencing bleeding during major surgical interventions, particularly after cardiac surgery [2,3]. However, there are also some studies with divergent results, therefore, a proven fibrinogen deficiency, determined by a quantitative, clot-based, functional assay or viscoelastic testing, and a goal-directed fibrinogen concentrate replacement therapy is recommended [3].
Highlights
A direct comparison of the pharmacokinetic profile of fibryga® and RiaSTAP®/Haemocomplettan® P has been performed [4] showing a larger area-under-the curve and a slower clearance for fibryga®
Similar purification and inactivation steps are included, the manufacturing process of fibrinogen concentrates remains specific for each product, leading to the question whether differences in the manufacturing processes might lead to small but potentially clinically relevant differences in composition
0.5 0.12 0.0035 2.1 0.12 97.0 0.02 1.8 a According to the European Pharmacopoeia 01/2008:0024 Specific activity [clottable protein/(total protein-albumin)]; Von Willebrand factor (VWF), Von Willebrand Factor; SEC, size exclusion chromatography
Summary
A direct comparison of the pharmacokinetic profile of fibryga® and RiaSTAP®/Haemocomplettan® P has been performed [4] showing a larger area-under-the curve (normalized) and a slower clearance for fibryga®. 0.5 0.12 0.0035 2.1 0.12 97.0 0.02 1.8 a According to the European Pharmacopoeia 01/2008:0024 Specific activity [clottable protein/(total protein-albumin)]; VWF, Von Willebrand Factor; SEC, size exclusion chromatography. Total protein [g] Fibrinogen antigen [g] Fibrinogen Clauss [g] Clottable protein [g] Fibronectin [mg] VWF antigen [U] Vitronectin [μg] Albumin [mg] FXIII activity [U] D-dimer [μg] Fibrinopeptide A [μg] Plasminogen [U]
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