Table 6.

Pharmacokinetic parameters for Kovaltry® (50 IU/kg dose) as determined in a chromogenic assay (data from product characteristics documentation).

	Patient age
Pharmacokinetic parameter	0 to <6 years (n = 8)	6 to <12 years (n = 10)	12–17 years (n = 5)	≥18 years (n = 21)
AUC [IU h/dL]	1544.7 ± 387.1	1214.5 ± 395.1	1572.0 ± 448.0	2103.4 ± 702.8
Cmaxa [IU/dL]	89.6 ± 27.4	81.6± 17.8	132.5 ± 46.3	133.1 ± 20.4
t$\frac{1}{2}$ [h]b	12.1 ± 2.7	12.0 ± 2.1	14.4 ± 5.5	14.2 ± 3.5
MRT IVc [h]	17.7 ± 3.6	17.8 ± 2.9	19.8 ± 5.8	19.9 ± 4.9
Vssd [dL/kg]	0.57 ± 0.13	0.79 ± 0.23	0.71 ± 0.39	0.50 ± 0.11
Clearance [dL/h/kg]	0.033 ± 0.009	0.045 ± 0.016	0.034 ± 0.010	0.027 ± 0.010

AUC, area under the curve.

^aMaximum drug concentration in plasma after a single dose.

^bTerminal half-life.

^cMean residence time after i.v. administration.

^dApparent volume distribution at steady state.