Novoeight® works by temporarily replacing the missing factor VIII protein that is needed for effective hemostasis.3
Designed for reliability with molecular precision.
Novoeight® offers consistency from batch to batch—measurable by a standard assay.1,2
Precisely B-domain truncated to obtain a well-defined product.4,5
Consistent heavy chain length.
FVIII analyzed by SDS-PAGE.4,a
SDS-PAGE gel comparison adapted from Thim et al.5
HC=heavy chain; LC=light chain; SDS-PAGE=sodium dodecyl sulfate polyacrylamide gel electrophoresis.
aThis study compared turoctocog alfa with commercially available rFVIII products using SDS-PAGE and Western blotting.4
Full Tyr-1680 sulfation.
Tyrosine sulfation supports high-affinity binding to vWF.4-6,b
- Binding to vWF has been shown to protect FVIII from premature clearance and degradation4-6
- Novoeight® is >99% sulfated at Tyr-16807
bThe clinical significance of the degree of tyrosine sulfation has not been established.
vWF=von Willebrand factor.
- Precise manufacturing process targets and selects molecules with fully intact A2 domains5,8
- Novoeight® is similar to endogenous FVIII in its active form, ensuring effective physiologic activity3,5
- F25 is a recombinant mAB
All pharmacokinetic studies with Novoeight® were conducted in previously treated patients with severe hemophilia A (factor VIII ≤1%). Analysis of plasma samples was conducted using both the one-stage clotting assay and the chromogenic assay.3
In a multi-center, multi-national, open-label, single dose pharmacokinetic study, 23 patients with severe hemophilia A received 50 international units/kg of Novoeight® intravenously. Two patients were below the age of 18 years (13 and 17 years). The pharmacokinetic parameters for 20 patients who completed the study are summarized in the following table:3
In a separate pharmacokinetic study, 28 pediatric patients with severe hemophilia A (14 patients were below 6 years of age and 14 patients were between 6 to <12 years of age) received a single dose of 50 international units/kg Novoeight®. The pharmacokinetic parameters of Novoeight® are summarized in the following table for both age groups.