Elucidation of Factor VIII Activity Pharmacokinetics: A Pooled Population Analysis in Patients With Hemophilia A Treated With Moroctocog Alfa

Abrantes, João A.Uppsala universitet,Institutionen för farmaceutisk biovetenskap (author)

Elucidation of Factor VIII Activity Pharmacokinetics : A Pooled Population Analysis in Patients With Hemophilia A Treated With Moroctocog Alfa

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.

Nielsen, Elisabet I.,1973-Uppsala universitet,Institutionen för farmaceutisk biovetenskap,Uppsala Univ, Dept Pharmaceut Biosci, Uppsala, Sweden.(Swepub:uu)elnie838 (author)
Korth-Bradley, J.Pfizer Inc, Collegeville, PA USA. (author)
Harnisch, L.Pfizer Ltd, Global Clin Pharmacol, Sandwich, Kent, England. (author)
Jönsson, Siv,1963-Uppsala universitet,Institutionen för farmaceutisk biovetenskap(Swepub:uu)sivjonss (author)
Uppsala universitetInstitutionen för farmaceutisk biovetenskap (creator_code:org_t)

In:Clinical Pharmacology and Therapeutics: Wiley102:6, s. 977-9880009-92361532-6535

By the author/editor: Abrantes, João A ...; Nielsen, Elisabe ...; Korth-Bradley, J ...; Harnisch, L.; Jönsson, Siv, 19 ...

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Basic Medicine; and Pharmacology and ...

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