Population pharmacokinetics of recombinant factor VIII: The relationships of pharmacokinetics to age and body weight

Bjorkman, Sven, Oh, MyungShin, Spotts, Gerald, Schroth, Phillip, Fritsch, Sandor, Ewenstein, Bruce M., Casey, Kathleen, Fischer, Kathelijn, Blanchette, Victor S. and Collins, Peter William ORCID: https://orcid.org/0000-0002-6410-1324 2012. Population pharmacokinetics of recombinant factor VIII: The relationships of pharmacokinetics to age and body weight. Blood 119 (2) , pp. 612-618. 10.1182/blood-2011-07-360594

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Abstract

Comparison of the pharmacokinetics (PK) of a coagulation factor between groups of patients can be biased by differences in study protocols, in particular between blood sampling schedules. This could affect clinical dose tailoring, especially in children. The aim of this study was to describe the relationships of the PK of factor VIII (FVIII) with age and body weight by a population PK model. The potential to reduce blood sampling was also explored. A model was built for FVIII PK from 236 infusions of recombinant FVIII in 152 patients (1-65 years of age) with severe hemophilia A. The PK of FVIII over the entire age range was well described by a 2-compartment model and a previously reported problem, resulting from differences in blood sampling, to compare findings from children and adults was practically abolished. The decline in FVIII clearance and increase in half-life with age could be described as continuous functions. Retrospective reduction of blood sampling from 11 to 5 samples made no important difference to the estimates of PK parameters. The obtained findings can be used as a basis for PK-based dose tailoring of FVIII in clinical practice, in all age groups, with minimal blood sampling.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine Systems Immunity Research Institute (SIURI)
Subjects:	R Medicine > R Medicine (General) R Medicine > RC Internal medicine
Publisher:	American Society of Hematology
ISSN:	0006-4971
Last Modified:	20 Oct 2022 08:28
URI:	https://orca.cardiff.ac.uk/id/eprint/28453

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