The purified
factor IX concentrates Nanotiv (Kabi Pharmacia), Immunine (Immuno),
Factor IX VHP (Bio-transfusion), Alphanine (Alpha) and
Mononine (Armour) have been studied in vitro and compared with the
prothrombin complex concentrates (PCCs)
Preconativ (Kabi Pharmacia) and Prothromplex TIM4 (Immuno). The measured values for
factor IX coagulant activity (IX:C) were in good agreement with the manufacturer's label values. In contrast to the PCCs, most of the purified concentrates were virtually devoid of other
vitamin K-dependent
coagulation factors, the inhibitors
protein C and S as well as
fibrinogen,
fibronectin and
immunoglobulins. Indicators of
thrombin generation, namely
prothrombin fragments 1 and 2 (F 1 + 2) and
thrombin-antithrombin complex (TAT), were present in varying amounts in all preparations. The specific activity in the purified concentrates exceeded that in the PCCs by
a factor of 50-100. Some differences in purity were found between the purified concentrates. In vivo, Nanotiv was compared with
Preconativ and Immunine with Prothromplex TIM4 in crossover studies in patients with severe
hemophilia B, and
Mononine was tested in a single
drug study. Most of the preparations yielded postinfusion increases in TAT, but not in F 1 + 2. Pharmacokinetic variables were analyzed with non-linear curve-fitting combined with model-independent methods. In retrospective comparisons, there were no apparent differences between Nanotiv,
Preconativ and
Mononine, whereas in vivo recovery seemed lower and the apparent clearance higher for Immunine and Prothromplex. Purified
factor IX concentrates were successfully used as cover for surgery or in immune tolerance induction.