Pharmacokinetic study of recombinant human factor IX in previously treated patients with hemophilia B in Taiwan
Journal
Journal of the Formosan Medical Association
Journal Volume
106
Journal Issue
4
Pages
281-287
Date Issued
2007
Author(s)
Abstract
Background/Purpose: The pharmacokinetic (PK) study of recombinant human factor IX (rFIX) has been done in patients with hemophilia B in areas other than Taiwan. However, wide patient-related variability in recovery is noted and there is no PK study of rFIX in Taiwanese patients with hemophilia B. The purpose of this study is to evaluate the PKs of the rFIX in Taiwanese patients with hemophilia B. Methods: A PK study of rFIX was performed in 10 previously treated Taiwanese patients with hemophilia B. Nine of them had severe hemophilia B and the other one had moderately severe hemophilia B. The mean age of our patients was 24.7 ± 8.6 years (mean ± SD) with a range of 15.5-47.0 years. Results: The infusion of 75 IU/kg of rFIX in our patients resulted in a mean FIX activity increase of 1.08 ± 0.27 IU/dL per IU/kg with a range of 0.3-1.49 IU/dL per IU/kg, and a mean in vivo recovery of 44.0 ± 9.5% with a range of 31.4-60.4%. The mean elimination half-life was 24.4 ± 6.4 hours with a range of 14.1-35.3 hours. The mean values of area under the curve, total body clearance, volume of distribution at steady state were 1363 ± 166IU × hour/dL, 4.84 ± 1.03 mL/hour/kg, and 144.3 ± 41.8 mL/kg, respectively. In addition, rFIX was well tolerated in our patients. Only two patients experienced mild treatment-related adverse events, including fever and feeling sleepy, respectively. Both of them resolved spontaneously without any sequences, and there was no thrombosis formation or inhibitor development in the following 6 months after rFIX infusion. Conclusion: The results of PK study of rFIX in our previously treated Taiwanese patients with hemophilia B are comparable to the reported results from other related studies conducted in different geographical areas. ? 2007 Elsevier & Formosan Medical Association.
SDGs
Other Subjects
recombinant blood clotting factor 9; adolescent; adult; area under the curve; article; clinical article; controlled study; disease severity; distribution volume; drug clearance; drug distribution; drug elimination; drug fever; drug half life; drug infusion; drug response; drug tolerability; hemophilia B; human; in vivo study; laboratory test; maximum plasma concentration; physical examination; side effect; somnolence; steady state; Taiwan; thrombosis; vital sign
Publisher
Scientific Communications International Ltd
Type
journal article