Recombinant factor VIII Fc fusion protein (rFVIIIFc) is a longer-acting FVIII.
Repeat (rats and monkeys) and high (monkeys) dosing of rFVIIIFc was well tolerated.
There were no local tolerance findings at infusion sites with repeated dosing.
There was no evidence of thrombosis at high doses (up to 20,000 IU/kg) in monkeys.
No toxicological effects were directly related to rFVIIIFc in rats or monkeys.