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Elucidation of Factor VIII Activity Pharmacokinetics: A Pooled Population Analysis in Patients With Hemophilia A Treated With Moroctocog Alfa
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. Uppsala Univ, Dept Pharmaceut Biosci, Uppsala, Sweden..
Pfizer Inc, Collegeville, PA USA..
Pfizer Ltd, Global Clin Pharmacol, Sandwich, Kent, England..
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2017 (English)In: Clinical Pharmacology and Therapeutics, ISSN 0009-9236, E-ISSN 1532-6535, Vol. 102, no 6, p. 977-988Article in journal (Refereed) Published
Abstract [en]

This study investigated the disposition of coagulation factor VIII activity in 754 patients with moderate to severe hemophilia A following the administration of moroctocog alfa, a B-domain deleted recombinant factor VIII. Data analyzed included patients aged 1 day to 73 years enrolled in 13 studies conducted over a period of 20 years in 25 countries. A two-compartment population pharmacokinetic model with a baseline model described the pooled data well. Body size, age, inhibitors, race, and analytical assay were identified as significant predictors of factor VIII disposition. In addition, simulations of prophylactic dosing schedules in several pediatric cohorts showed large variability and suggest that younger patients would require higher weight-adjusted doses than adolescents to achieve target factor VIII trough activity when receiving every other day or twice weekly dosing.

Place, publisher, year, edition, pages
2017. Vol. 102, no 6, p. 977-988
National Category
Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:uu:diva-342208DOI: 10.1002/cpt.716ISI: 000414921800026PubMedID: 28437834OAI: oai:DiVA.org:uu-342208DiVA, id: diva2:1183987
Available from: 2018-02-20 Created: 2018-02-20 Last updated: 2018-02-20Bibliographically approved

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Abrantes, João A.Nielsen, Elisabet I.Jönsson, Siv

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