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Population pharmacokinetics of recombinant factor VIII: the relationships of pharmacokinetics to age and body weight
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
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2012 (English)In: Blood, ISSN 0006-4971, E-ISSN 1528-0020, Vol. 119, no 2, 612-618 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2012. Vol. 119, no 2, 612-618 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-168588DOI: 10.1182/blood-2011-07-360594ISI: 000299268900041OAI: oai:DiVA.org:uu-168588DiVA: diva2:501544
Available from: 2012-02-14 Created: 2012-02-13 Last updated: 2012-02-14Bibliographically approved

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