Use of Recombinant Factor VIIa Utilization Among a Hospitalized Pediatric Population

Background: recombinant activated factor vii (rfviia; novoseven® rt, novo nordisk, bagsvaerd, denmark) is a synthetic pro-coagulation factor derived from hamster kidney cells.objectives: the purpose of this study was to evaluate the prescribing patterns of recombinant factor viia (rfviia) at a single, tertiary care pediatric hospital by indication of usage and dose administered.materials and methods: retrospective data was queried from the centralized pharmacy medication computer system. all patients receiving rfviia between september 2009 and september 2012 were included in the analysis.results: over the three year period 887 doses of rfviia were administered to 186 patients. only 4% of patients received rfviia for an fda approved indication. the most common indication for off-label usage was refactory bleeding either during or following cardiothoracic surgery, accounting for 83% of all doses administered off-label. despite being only a small portion of all patients receiving rfviia, the group receiving rfviia for an fda approved indication received the majority of doses dispensed (72.6% of all doses). a significant difference (p < 0.0001) was noted in the dose administered to patients in the on-label versus off-label groups. patients in the on-label group received a median dose of 113.6 mcg/kg (iqr 54.5 mcg/kg - 172.7 mcg/kg) versus a median dose of 74.4 mcg/kg (iqr 20.0 mcg/kg - 128.8 mcg/kg) in the off-label group.conclusions: prospective pediatric studies are needed to evaluate rfviia efficacy and safety in populations receiving the medication for off-label indications given increasing concerns involving the potential adverse effect profile of the medication as well as to develop evidence based dosing parameters for these indications.