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Categories: Hemophilia
Amy D. Shapiro, MD
Increasing evidence suggests that a single dose of 270 μg/kg recombinant activated factor VII (rFVIIa) may be a convenient, safe, and effective alternative to the repeat-dose regimen for hemophilia patients with inhibitors. Three recent trials investigating on-demand treatment (Kavakli et al 2006, Santagostino et al 2006, and Young et al 2008) lend further weight to earlier reports demonstrating that a single dose of 270 μg/kg rFVIIa is as effective as a repeat-dose schedule of 3 x 90 μg/kg rFVIIa in producing hemostasis, reducing the need for additional hemostatic medications, and improving pain and mobility in joints affected by hemarthroses. The single-dose regimen is advantageous as it may reduce both the difficulties caused by the need for repeated venous access and the interruption of daily activities associated with repeat dosing. Safety data from these three trials, along with those from a fourth study investigating the prophylactic use of 270 μg/kg rFVIIa, also demonstrate no additional or altered safety profile associated with single-dose treatment. These findings suggest that a single dose of 270 μg/kg rFVIIa is as safe and effective a hemostatic regimen as the standard lower, more frequent dose regimen and provides comparable bleeding control in hemophilia patients with inhibitors. The single-dose 270 μg/kg rFVIIa regimen utilized similar product consumption to the 3 3 90 μg/kg rFVIIa treatment regimen.