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PK profile

Kovaltry pharmacokinetic profile across age groups*

Children (1 to <12 years)1
1 to <6 years

(n=5)

Children
6 to <12 years

(n=10)

Children 2
All PTPs

(n=15)

Children 3

Half-life of pediatrics PTPs (<12 years) using the chromogenic assay.
Geometric mean (%CV).

Adolescents and adults (≥12 years)1
At the beginning
of the study

(n=19)

Adolescents
After 6–12 months
of prophylactic
treatment

(n=19)

Adolescents

Half-life of adult PTPs (12–62 years) using the one-stage assay.
Geometric mean (%CV).

PK of Kovaltry and selected currently available rFVIII products1,9–11†

Terminal half-life (hours) in children ≤12 years old1,9,10*

11.8

1 to <6 years of age
(n=5)

11.9

6 to <12 years of age
(n=10)

Kovaltry1‡

12.3

<6 years of age
(n=23)

13.5

6 to <12 years of age
(n=31)

Eloctate®9§

11.91

<6 years of age
(n=13)

13.08

6 to <12 years of age
(n=13)

Nuwiq®10¶

Adapted from Kovaltry Product Monograph, Eloctate® Product Monograph and Nuwiq® Product Monograph.

 

* Clinical significance unknown.
† Data from separate Product Monographs. Comparative clinical significance unknown. Please refer to the respective Product Monographs for complete information.
‡ Half-life of pediatric PTPs (<12 years) using chromogenic assay. Presented in geometric mean.
§ Half-life of pediatric PTPs (<12 years) using one-stage assay. Presented in geometric mean.
¶ Half-life of pediatric PTPs (<12 years) at initial assessment using one-stage assay. Presented in mean.

 

PTPs=previously treated patients.