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
Mechanism of action.
B-domain truncated.
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.
Immunoaffinity chromatography.
- 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
Pharmacokinetics studies.3
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
Pharmacokinetics of Novoeight® in 20 adult and adolescent patients with hemophilia A3
Parameters
Incremental Recovery
(IU/mL)/(IU/kg)
Clotting Assay: 0.020 (0.002)
Chromogenic Assay: 0.028 (0.006)
AUC (IU*h/mL)
Clotting Assay: 14.2 (3.8)
Chromogenic Assay: 18.7 (5.1)
CL (mL/h/kg)
Clotting Assay: 3.74 (0.95)
Chromogenic Assay: 2.87 (0.80)
t1/2 (h)
Clotting Assay: 10.8 (4.9)
Chromogenic Assay: 12.0 (9.3)
Vss (mL/kg)
Clotting Assay: 53.4 (10.9)
Chromogenic Assay: 44.3 (28.2)
Cmax (IU/mL)
Clotting Assay: 1.07 (0.16)
Chromogenic Assay: 1.54 (0.29)
MRT (h)
Clotting Assay: 15.4 (6.4)
Chromogenic Assay: 16.4 (10.1)
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.
Pharmacokinetics of Novoeight® in 28 pediatric patients with hemophilia A3
Parameters
Incremental Recovery
(IU/mL)/(IU/kg)
Clotting Assay 0 to <6 years: 0.018 (0.007); 6 to <12 years: 0.020 (0.004)
Chromogenic Assay 0 to <6 years: 0.022 (0.006); 6 to <12 years: 0.025 (0.006)
AUC (IU*h/mL)
Clotting Assay 0 to <6 years: 9.9 (4.1); 6 to <12 years: 11.1 (3.7)
Chromogenic Assay 0 to <6 years: 12.2 (4.4); 6 to <12 years: 14.4 (3.5)
CL (mL/h/kg)
Clotting Assay 0 to <6 years: 6.26 (3.73); 6 to <12 years: 5.02 (1.67)
Chromogenic Assay 0 to <6 years: 4.60 (1.75); 6 to <12 years: 3.70 (1.00)
t1/2 (h)
Clotting Assay 0 to <6 years: 7.7 (1.8); 6 to <12 years: 8.0 (1.9)
Chromogenic Assay 0 to <6 years: 10.0 (1.7); 6 to <12 years: 9.4 (1.5)
Vss (mL/kg)
Clotting Assay 0 to <6 years: 57.3 (26.8); 6 to <12 years: 46.8 (10.6)
Chromogenic Assay 0 to <6 years: 55.8 (23.7); 6 to <12 years: 41.2 (6.0)
Cmax (IU/mL)
Clotting Assay 0 to <6 years: 1.00 (0.58); 6 to <12 years: 1.07 (0.35)
Chromogenic Assay 0 to <6 years: 1.12 (0.31); 6 to <12 years: 1.25 (0.27)
MRT (h)
Clotting Assay 0 to <6 years: 9.7 (2.5); 6 to <12 years: 9.9 (2.6)
Chromogenic Assay 0 to <6 years: 12.1 (1.9); 6 to <12 years: 11.6 (2.3)
