Literature DB >> 22286158

Factors influencing the pharmacokinetics of prophylactic posaconazole oral suspension in patients with acute myeloid leukemia or myelodysplastic syndrome.

J J Vehreschild1, C Müller, F Farowski, M J G T Vehreschild, O A Cornely, U Fuhr, K-A Kreuzer, M Hallek, V Kohl.   

Abstract

OBJECTIVES: To estimate the pharmacokinetic (PK) properties of posaconazole in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) undergoing chemotherapy in a clinical setting.
METHODS: Posaconazole concentrations in patients with AML/MDS receiving prophylactic posaconazole were determined by high-performance 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, co-administration of antineoplastic chemotherapy, ranitidine or pantoprazole, coincident fever, diarrhea, leukocyte counts, and γ-glutamyltransterase plasma activity.
RESULTS: A total of 643 serum concentrations of posaconazole from 84 patients were obtained. A one-compartment model with first order absorption and elimination as the basic structural model appropriately described the data, with an apparent clearance of 56.8 L/h [95% confidence interval (CI) 52.8–60.8 L/h] and an apparent volume of distribution of 2,130 L (95% CI 1,646–2,614 L). Significant effects on apparent clearance (CL/F) were found for presence of diarrhea and for co-medication with proton-pump inhibitors (1.5- and 1.6-fold increase in CL/F, respectively), weight (33.4 L larger apparent volume of distribution per kilogram), and co-administration of chemotherapy (0.6-fold lower apparent volume of distribution).
CONCLUSION: We 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 co-administration of chemotherapy or proton-pump inhibitors appear justified before therapeutic drug monitoring results are available. Further investigation of the interaction between different chemotherapeutic regimens and posaconazole is warranted.

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Year:  2012        PMID: 22286158     DOI: 10.1007/s00228-012-1212-y

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN: 0031-6970            Impact factor:   2.953


  28 in total

1.  Posaconazole serum concentrations among cardiothoracic transplant recipients: factors impacting trough levels and correlation with clinical response to therapy.

Authors:  Ryan K Shields; Cornelius J Clancy; Aniket Vadnerkar; Eun J Kwak; Fernanda P Silveira; Rima C Abdel Massih; Joseph M Pilewski; Maria Crespo; Yoshiya Toyoda; Jay K Bhama; Christian Bermudez; M Hong Nguyen
Journal:  Antimicrob Agents Chemother       Date:  2010-12-28       Impact factor: 5.191

2.  PsN-Toolkit--a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM.

Authors:  Lars Lindbom; Pontus Pihlgren; E Niclas Jonsson; Niclas Jonsson
Journal:  Comput Methods Programs Biomed       Date:  2005-09       Impact factor: 5.428

3.  Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease.

Authors:  Andrew J Ullmann; Jeffrey H Lipton; David H Vesole; Pranatharthi Chandrasekar; Amelia Langston; Stefano R Tarantolo; Hildegard Greinix; Wellington Morais de Azevedo; Vijay Reddy; Navdeep Boparai; Lisa Pedicone; Hernando Patino; Simon Durrant
Journal:  N Engl J Med       Date:  2007-01-25       Impact factor: 91.245

4.  Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America.

Authors:  Thomas J Walsh; Elias J Anaissie; David W Denning; Raoul Herbrecht; Dimitrios P Kontoyiannis; Kieren A Marr; Vicki A Morrison; Brahm H Segal; William J Steinbach; David A Stevens; Jo-Anne van Burik; John R Wingard; Thomas F Patterson
Journal:  Clin Infect Dis       Date:  2008-02-01       Impact factor: 9.079

5.  Posaconazole therapeutic drug monitoring: a reference laboratory experience.

Authors:  George R Thompson; Michael G Rinaldi; Gennethel Pennick; Sheryl A Dorsey; Thomas F Patterson; James S Lewis
Journal:  Antimicrob Agents Chemother       Date:  2009-03-02       Impact factor: 5.191

6.  Clinical effectiveness of posaconazole prophylaxis in patients with acute myelogenous leukaemia (AML): a 6 year experience of the Cologne AML cohort.

Authors:  J J Vehreschild; M J G T Rüping; H Wisplinghoff; F Farowski; A Steinbach; R Sims; A Stollorz; K-A Kreuzer; M Hallek; C Bangard; O A Cornely
Journal:  J Antimicrob Chemother       Date:  2010-04-21       Impact factor: 5.790

7.  Pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers.

Authors:  Gopal Krishna; Allen Moton; Lei Ma; Matthew M Medlock; James McLeod
Journal:  Antimicrob Agents Chemother       Date:  2008-12-15       Impact factor: 5.191

8.  Correlation of in vitro activity, serum levels, and in vivo efficacy of posaconazole against Rhizopus microsporus in a murine disseminated infection.

Authors:  M Mar Rodríguez; F Javier Pastor; Enrique Calvo; Valentina Salas; Deanna A Sutton; Josep Guarro
Journal:  Antimicrob Agents Chemother       Date:  2009-09-28       Impact factor: 5.191

9.  Posaconazole: a next-generation triazole antifungal.

Authors:  Fedja Farowski; Jörg J Vehreschild; Oliver A Cornely
Journal:  Future Microbiol       Date:  2007-06       Impact factor: 3.165

10.  Anidulafungin versus fluconazole for invasive candidiasis.

Authors:  Annette C Reboli; Coleman Rotstein; Peter G Pappas; Stanley W Chapman; Daniel H Kett; Deepali Kumar; Robert Betts; Michele Wible; Beth P Goldstein; Jennifer Schranz; David S Krause; Thomas J Walsh
Journal:  N Engl J Med       Date:  2007-06-14       Impact factor: 91.245

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  12 in total

1.  Posaconazole Plasma Concentrations on Days Three to Five Predict Steady-State Levels.

Authors:  Jürgen Prattes; Wiebke Duettmann; Martin Hoenigl
Journal:  Antimicrob Agents Chemother       Date:  2016-08-22       Impact factor: 5.191

2.  Understanding variability in posaconazole exposure using an integrated population pharmacokinetic analysis.

Authors:  Michael J Dolton; Roger J M Brüggemann; David M Burger; Andrew J McLachlan
Journal:  Antimicrob Agents Chemother       Date:  2014-09-08       Impact factor: 5.191

3.  Comparison of the Efficacy of Posaconazole Delayed Release Tablets and Suspension in Pediatric Hematology/Oncology Patients.

Authors:  Erika N Wass; Elvin A Hernandez; Caroline M Sierra
Journal:  J Pediatr Pharmacol Ther       Date:  2020 Jan-Feb

Review 4.  Therapeutic drug monitoring for triazoles: A needs assessment review and recommendations from a Canadian perspective.

Authors:  Michel Laverdiere; Eric J Bow; Coleman Rotstein; Julie Autmizguine; Raewyn Broady; Gary Garber; Shariq Haider; Trana Hussaini; Shahid Husain; Philippe Ovetchkine; Jack T Seki; Yves Théorêt
Journal:  Can J Infect Dis Med Microbiol       Date:  2014 Nov-Dec       Impact factor: 2.471

Review 5.  Pharmacokinetics and Pharmacodynamics of Posaconazole.

Authors:  Lu Chen; Elke H J Krekels; Paul E Verweij; Jochem B Buil; Catherijne A J Knibbe; Roger J M Brüggemann
Journal:  Drugs       Date:  2020-05       Impact factor: 9.546

Review 6.  Clinical Pharmacokinetics of Second-Generation Triazoles for the Treatment of Invasive Aspergillosis and Candidiasis.

Authors:  Zorica Jović; Slobodan M Janković; Dejana Ružić Zečević; Dragan Milovanović; Srđan Stefanović; Marko Folić; Jasmina Milovanović; Marina Kostić
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2019-04       Impact factor: 2.569

7.  Evaluation of Posaconazole Pharmacokinetics in Adult Patients with Invasive Fungal Infection.

Authors:  Sarah Allegra; Giovanna Fatiguso; Silvia De Francia; Fabio Favata; Elisa Pirro; Chiara Carcieri; Amedeo De Nicolò; Jessica Cusato; Giovanni Di Perri; Antonio D'Avolio
Journal:  Biomedicines       Date:  2017-11-20

8.  Voriconazole and posaconazole therapeutic drug monitoring: a retrospective study.

Authors:  Whitley M Yi; Kelly E Schoeppler; Jaclyn Jaeger; Scott W Mueller; Robert MacLaren; Douglas N Fish; Tyree H Kiser
Journal:  Ann Clin Microbiol Antimicrob       Date:  2017-09-11       Impact factor: 3.944

Review 9.  Antifungal prophylaxis and novel drugs in acute myeloid leukemia: the midostaurin and posaconazole dilemma.

Authors:  Jannik Stemler; Philipp Koehler; Christian Maurer; Carsten Müller; Oliver A Cornely
Journal:  Ann Hematol       Date:  2020-06-08       Impact factor: 3.673

10.  Implications for IV posaconazole dosing in the era of obesity.

Authors:  Roeland E Wasmann; Cornelis Smit; Marieke H van Donselaar; Eric P A van Dongen; René M J Wiezer; Paul E Verweij; David M Burger; Catherijne A J Knibbe; Roger J M Brüggemann
Journal:  J Antimicrob Chemother       Date:  2020-04-01       Impact factor: 5.790

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