Journal
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
Volume 80, Issue 5, Pages 1042-1050Publisher
WILEY-BLACKWELL
DOI: 10.1111/bcp.12691
Keywords
oseltamivir; population pharmacokinetics; pregnancy
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Funding
- Obstetric Pharmacology Research Unit Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) [5U10 HD 047905, U10 HD047892, 3U10 HD047891-05S2]
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AimsPhysiological changes in pregnancy are expected to alter the pharmacokinetics of various drugs. The objective of this study was to evaluate systematically the pharmacokinetics of oseltamivir (OS), a drug used in the treatment of influenza during pregnancy. MethodsA multicentre steady-state pharmacokinetic study of OS was performed in 35 non-pregnant and 29 pregnant women. Plasma concentration-time profiles were analyzed using both non-compartmental and population pharmacokinetic modelling (pop PK) and simulation approaches. A one compartment population pharmacokinetic model with first order absorption and elimination adequately described the pharmacokinetics of OS. ResultsThe systemic exposure of oseltamivir carboxylate (OC, active metabolite of OS) was reduced approximately 30 (19-36)% (P<0.001) in pregnant women. Pregnancy significantly (P<0.001) influenced the clearance (CL/F) and volume of distribution (V/F) of OC. Both non-compartmental and population pharmacokinetic approaches documented approximately 45 (23-62)% increase in clearance (CL/F) of OC during pregnancy. ConclusionBased on the decrease in exposure of the active metabolite, the currently recommended doses of OS may need to be increased modestly in pregnant women in order to achieve comparable exposure with that of non-pregnant women.
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