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Title of Journal: Eur J Clin Pharmacol

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Abbravation: European Journal of Clinical Pharmacology

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Springer-Verlag

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1432-1041

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Factors influencing the pharmacokinetics of prophy

Authors: J J Vehreschild C Müller F Farowski M J G T Vehreschild O A Cornely U Fuhr KA Kreuzer M Hallek V Kohl
Publish Date: 2012/01/28
Volume: 68, Issue: 6, Pages: 987-995
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Abstract

Posaconazole concentrations in patients with AML/MDS receiving prophylactic posaconazole were determined by highperformance liquid chromatography A population PK model with nonlinear mixed effect modeling was developed The list of tested covariates included age weight height gender posaconazole dose ethnicity coadministration of antineoplastic chemotherapy ranitidine or pantoprazole coincident fever diarrhea leukocyte counts and γglutamyltransterase plasma activityA total of 643 serum concentrations of posaconazole from 84 patients were obtained A onecompartment model with first order absorption and elimination as the basic structural model appropriately described the data with an apparent clearance of 568 L/h 95 confidence interval CI 528–608 L/h and an apparent volume of distribution of 2130 L 95 CI 1646–2614 L Significant effects on apparent clearance CL/F were found for presence of diarrhea and for comedication with protonpump inhibitors 15 and 16fold increase in CL/F respectively weight 334 L larger apparent volume of distribution per kilogram and coadministration of chemotherapy 06fold lower apparent volume of distributionWe developed a prediction basis for mean posaconazole concentrations in AML/MDS patients Patient weight presence of diarrhea and concomitant medication chemotherapy and pantoprazole showed significant effects on posaconazole exposure Corresponding adjustments of the starting dose according to the presence of diarrhea and during the coadministration of chemotherapy or protonpump inhibitors appear justified before therapeutic drug monitoring results are available Further investigation of the interaction between different chemotherapeutic regimens and posaconazole is warrantedOliver A Cornely is supported by the German Federal Ministry of Research and Education BMBF grant 01KN0706 has received research grants from Actelion Astellas Basilea Bayer Biocryst Celgene F2G Genzyme Gilead Merck/Schering Miltenyi Optimer Pfizer Quintiles and Viropharma is a consultant to Astellas Basilea F2G Gilead Merck/Schering Mölnlycke Optimer and Pfizer and has received lecture honoraria from Astellas Gilead Merck/Schering and Pfizer

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