The pharmacology of a new pasteurized antihemophilic factor concentrate derived from human blood plasma.
The pharmacology of a new pasteurized factor VIII (FVIII) concentrate derived from human blood plasma was studied in 23 adults with hemophilia A. In Part 1 of the study involving six nonbleeding subjects, the mean increase in FVIII activity was 1.43 +/- 0.34 U per ml 10 minutes after an intravenous dose of 50 U per kg. The intravascular survival kinetics in these six patients showed a biphasic decay curve with an initial mean half-life of 5.1 +/- 1.2 hours probably representing early redistribution, and a late half-life of 13.3 +/- 4.9 hours. In Part 2 of the study, the activity at 10 minutes was measured in another 17 patients, as well as in one patient already studied in Part 1. The mean increase in activity with the 24 observations was 1.13 +/- 0.37 U per ml with a mean FVIII dosage of 51.0 +/- 2.6 U per kg of body weight. Only one patient had an allergic reaction, which did not recur when the patient was given a second lot.
Rousell
R H
RH
Clinical Research Department, Cutter Biological, Berkeley, California.
Kasper
C K
CK
Schwartz
R S
RS
D000328:Adult; D005169:Factor VIII / Q000009:adverse effects / Q000378:metabolism / Q000493:pharmacokinetics*; D006207:Half-Life; D006467:Hemophilia A / Q000628:therapy; D006358:Hot Temperature; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D010949:Plasma / Q000032:analysis* / Q000378:metabolism; D013242:Sterilization; D065227:Transfusion Reaction
D005169:Factor VIII