title: Comparative evaluation of the pharmacokinetics of three monoclonal factor VIII concentrates.
abstract: Hemofil M, Monoclate HT, and Monoclate P are high-purity Factor VIII concentrates, obtained from plasma by immunoaffinity chromatography with monoclonal antibodies specific for Factor VIII (Hemofil M) or von Willebrand Factor (Monoclate HT and Monoclate P). The concentrates are subjected to virucidal treatments: a solvent/detergent method (TNBP/Na-cholate) for Hemofil M, heating in the lyophilized state and in solution (pasteurization) for Monoclate HT and Monoclate P, respectively. Since these differences in the manufacturing process might result in different in vivo characteristics of the concentrates, we compared their in vivo behavior in a cross-over, single-dose, pharmacokinetic study performed in 10 non-bleeding patients with severe hemophilia A. The experimental conditions (Factor VIII dose, number and timing of blood sampling, Factor VIII assay methods, calculation of pharmacokinetic parameters) were identical for the three products. The results showed that the clearance, the mean residence time, and the volume of distribution did not differ among the three products.
authors.affiliation: Hematology Department, University Hospital of Florence, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Morfini
authors.forename: P M
authors.initials: PM
authors.lastname: Mannucci
authors.forename: G
authors.initials: G
authors.lastname: Longo
authors.forename: S
authors.initials: S
authors.lastname: Cinotti
authors.forename: A
authors.initials: A
authors.lastname: Messori
mesh_terms: D005169:Factor VIII / Q000493:pharmacokinetics*; D006207:Half-Life; D006467:Hemophilia A / Q000378:metabolism*; D006801:Humans; D008657:Metabolic Clearance Rate; D011897:Random Allocation
chemical_list: D005169:Factor VIII