Monoclonal antibody purified
factor IX concentrate,
Mononine (Armour
Pharmaceutical Company, Kankakee, Illinois, USA), is a recently developed replacement factor concentrate for the treatment of patients with
hemophilia B. The pharmacokinetic properties of
monoclonal antibody purified
factor IX concentrate (MAb
Factor IX concentrate) have been evaluated in only small samples of patients, and little is known about those factors that might influenced in vivo recovery of
factor IX after infusion is a larger patient population. In vivo recovery of
factor IX was therefore evaluated for 80 different indications in 72 patients who received MAb
Factor IX concentrate for the management of spontaneous or
trauma-induced
bleeding, or as prophylaxis with surgery. The average recovery after infusions for presurgical pharmacokinetic analysis (mean +/- standard deviation) was 1.28 +/- 0.56 U/dl rise per U/kg infused (range 0.41-2.80), and the average recovery after all infusions for treatment was 1.23 +/- 0.49 U/dl rise per U/kg infused (range - 0.35-2.92). Recovery values for multiple MAb
Factor IX doses in a given patient were also variable; the average recovery was 1.22 +/- 0.53 U/dl rise per U/kg given, and standard deviations ranged from 0.03 to 1.26. Patient age, weight, and MAb
Factor IX concentrate dose minimally but significantly influenced
factor IX recovery. There was no significant effect of either race, history of previous thrombotic complications during treatment with other replacement factor concentrates, or
bleeding state on recovery. All of the patients treated with this preparation experienced excellent hemostasis, and no thrombotic complications were observed.