Korean J Hematol.  2001 May;36(2):148-153.

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

• Yoon HJ
• Lee SY
• Hwang TJ
• Sohn YT

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.

Keyword

Pharmacokinetics; Recovery; Half-life; Monoclonal-antibody-purified; Factor VIII concentrate; GreenMono (R); Hemofil (R) M

MeSH Terms

Blood Cell Count
Factor VIII*
Half-Life
Hemophilia A*
Humans
Kidney Function Tests
Licensure
Liver
Pharmacokinetics*
Plasma
Prospective Studies*
Urinalysis
Factor VIII