ABSTRACT
-Information contained in this review of the use of recombinant factor VIIa (rFVIIa,
NovoSeven®) in the pediatric population was obtained through review of literature
and abstraction of data available at Novo Nordisk. Pharmacokinetic investigations
in hemophilic children suggest that rFVIIa may have a shorter half-life and more rapid
clearance in the pediatric population than in adults, with resultant implications
for dosing. Analysis of pediatric data from various studies and case reports indicates
that rFVIIa is safe and effective for the control of spontaneous or surgical bleeding
in hemophilic children with inhibitors, including central nervous system bleeds, and
bleeding episodes during immune tolerance induction therapy. The very young pediatric
population (less than 1 year of age) poses specific difficulties in treatment, and
rFVIIa provides an effective alternative to other therapeutic modalities. In some
hemophilia B patients with inhibitors, anaphylactic reaction to FIX infusions is a
potentially life-threatening problem, for which rFVIIa may provide the only safe alternative
therapy for the control of bleeding episodes. Continuous infusion of rFVIIa has also
been used effectively in individual cases. Optimal dosing regimens, both intermittent
and continuous, still need to be determined in children.
KEYWORD
Hemophilia - inhibitors - rFVIIa - factor VII - factor IX
