A Prospective Study on the Pharmacokinetics of Monoclonal-antibody-purified Factor VIII Concentrate (GreenMono (R)) in Previously Treated Subjects with Hemophilia A / 대한혈액학회지

ABSTRACT

BACKGROUND: GreenMono (R) is a plasma-derived factor VIII concentrate produced by Greencross PD based on a license of Baxters monoclonal antibody technology. The purpose of this prospective study was to document the pharmacokinetics and the acute safety of the drug. METHODS: Pharmacokinetic analysis was performed in 13 previously treated patients with hemophilia A after administration of GreenMono (R) with dose of 50units/kg. The adverse effects were observed, and changes of laboratory tests, including complete blood counts, liver and kidney function tests, urinalysis, were assessed 48 hours after the drug administration. Bethesda assay for inhibitors to factor VIII were performed on 3-7 days. RESULTS: The recovery rate of GreenMono (R) was 99+-22% (range, 71~136%), and plasma beta half life analysed by 2-compartment model was 15.7+-6.6 hours (range, 9.7~35.9 hours). No clinically significant immediate adverse effects were observed after administration of GreenMono (R). No significant change in laboratory tests were observed after administration of GreenMono (R). Inhibitors to factor VIII were maintained below 0.6 BU. CONCLUSION: GreenMono (R) is effective in pharmacokinetic analysis, and is safe without any immediate adverse effect.