Use of Recombinant Factor VIIa Utilization Among a Hospitalized Pediatric Population
| Author | Nathan E Thompson | en |
| Author | Melissa Meuler | en |
| Author | John P Scott | en |
| Issued Date | 2015-08-31 | en |
| Abstract | 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. | en |
| DOI | https://doi.org/10.17795/compreped-25505 | en |
| Keyword | Blood Coagulation | en |
| Keyword | Factor VIIa | en |
| Keyword | FDA | en |
| Publisher | Brieflands | en |
| Title | Use of Recombinant Factor VIIa Utilization Among a Hospitalized Pediatric Population | en |
| Type | Research Article | en |
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