Table of Contents
Leukemia Research and Treatment
Volume 2017, Article ID 3460892, 6 pages
https://doi.org/10.1155/2017/3460892
Research Article

Evaluation of Serum Posaconazole Concentrations in Patients with Hematological Malignancies Receiving Posaconazole Suspension Compared to the Delayed-Release Tablet Formulation

1Department of Pharmacy, West Virginia University Hospitals, Morgantown, WV, USA
2Osborn Hematopoietic Malignancy and Transplantation Program, MBRCC, West Virginia University, Morgantown, WV, USA
3Department of Biostatistics, West Virginia University, Morgantown, WV, USA

Correspondence should be addressed to Aaron Cumpston; gro.enicidemuvw@anotspmuc

Received 14 March 2017; Accepted 17 May 2017; Published 11 June 2017

Academic Editor: Daniela Cilloni

Copyright © 2017 Morgan Belling et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. O. A. Cornely, J. Maertens, D. J. Winston et al., “Posaconazole versus fluconazole or itraconazole prophylaxis in patients with neutropenia,” The New England Journal of Medicine, vol. 356, no. 4, pp. 348–359, 2007. View at Publisher · View at Google Scholar · View at Scopus
  2. A. J. Ullmann, J. H. Lipton, D. H. Vesole et al., “Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease,” The New England Journal of Medicine, vol. 356, no. 4, pp. 335–347, 2007. View at Publisher · View at Google Scholar · View at Scopus
  3. Noxafil (posaconazole) [package insert], Merck and Co., Inc., Whitehouse Station, NJ, USA, 2015.
  4. G. Krishna, M. AbuTarif, F. Xuan, M. Martinho, D. Angulo, and O. A. Cornely, “Pharmacokinetics of oral posaconazole in neutropenic patients receiving chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome,” Pharmacotherapy, vol. 28, no. 10, pp. 1223–1232, 2008. View at Publisher · View at Google Scholar · View at Scopus
  5. D. Lebeaux, F. Lanternier, C. Elie et al., “Therapeutic drug monitoring of posaconazole: a monocentric study with 54 adults,” Antimicrobial Agents and Chemotherapy, vol. 53, no. 12, pp. 5224–5229, 2009. View at Publisher · View at Google Scholar · View at Scopus
  6. M. A. Abutarif, G. Krishna, and P. Statkevich, “Population pharmacokinetics of posaconazole in neutropenic patients receiving chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome,” Current Medical Research and Opinion, vol. 26, no. 2, pp. 397–405, 2010. View at Publisher · View at Google Scholar · View at Scopus
  7. V. Kohl, C. Müller, O. A. Cornely et al., “Factors influencing pharmacokinetics of prophylactic posaconazole in patients undergoing allogeneic stem cell transplantation,” Antimicrobial Agents and Chemotherapy, vol. 54, no. 1, pp. 207–212, 2010. View at Publisher · View at Google Scholar · View at Scopus
  8. R. Courtney, D. Wexler, E. Radwanski, J. Lim, and M. Laughlin, “Effect of food on the relative bioavailability of two oral formulations of posaconazole in healthy adults,” British Journal of Clinical Pharmacology, vol. 57, no. 2, pp. 218–222, 2003. View at Publisher · View at Google Scholar · View at Scopus
  9. A. L. Ross, D. Slain, A. Cumpston, A. M. Bryant, M. Hamadani, and M. Craig, “Evaluation of an alternative posaconazole prophylaxis regimen in haematological malignancy patients receiving concomitant stress ulcer prophylaxis,” International Journal of Antimicrobial Agents, vol. 40, no. 6, pp. 557–561, 2012. View at Publisher · View at Google Scholar · View at Scopus
  10. W. K. Kraft, P. S. Chang, M. L. P. S. Van Iersel, H. Waskin, G. Krishna, W. M. Kersemaekers et al., “Posaconazole tablet pharmacokinetics: lack of effect of concomitant medications altering gastric pH and gastric motility in healthy subjects,” Antimicrobial Agents and Chemotherapy, vol. 58, no. 7, pp. 4020–4025, 2014. View at Publisher · View at Google Scholar · View at Scopus
  11. G. Krishna, L. Ma, M. Martinho, and E. O'Mara, “Single-dose phase I study to evaluate the pharmacokinetics of posaconazole in new tablet and capsule formulations relative to oral suspension,” Antimicrobial Agents and Chemotherapy, vol. 56, no. 8, pp. 4196–4201, 2012. View at Publisher · View at Google Scholar · View at Scopus
  12. G. Krishna, L. Ma, M. Martinho, R. A. Preston, and E. O'mara, “A new solid oral tablet formulation of posaconazole: a randomized clinical trial to investigate rising single- and multiple-dose pharmacokinetics and safety in healthy volunteers,” Journal of Antimicrobial Chemotherapy, vol. 67, no. 11, pp. 2723–2730, 2012. View at Google Scholar
  13. R. F. Duarte, J. López-Jiménez, O. A. Cornely et al., “Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia,” Antimicrobial Agents and Chemotherapy, vol. 58, no. 10, pp. 5758–5765, 2014. View at Publisher · View at Google Scholar · View at Scopus
  14. R. Courtney, S. Pai, M. Laughlin, J. Lim, and V. Batra, “Pharmacokinetics, safety, and tolerability of oral posaconazole administered in single and multiple doses in healthy adults,” Antimicrobial Agents and Chemotherapy, vol. 49, pp. 804–808, 2004. View at Google Scholar
  15. A. M. Bryant, D. Slain, A. Cumpston, and M. Craig, “A post-marketing evaluation of posaconazole plasma concentrations in neutropenic patients with haematological malignancy receiving posaconazole prophylaxis,” International Journal of Antimicrobial Agents, vol. 37, no. 3, pp. 266–269, 2011. View at Publisher · View at Google Scholar · View at Scopus
  16. C. Eiden, J. C. Meniane, H. Peyrière et al., “Therapeutic drug monitoring of posaconazole in hematology adults under posaconazole prophylaxis: influence of food intake,” European Journal of Clinical Microbiology and Infectious Diseases, vol. 31, no. 2, pp. 161–167, 2012. View at Publisher · View at Google Scholar · View at Scopus
  17. M. Hoenigl, R. B. Raggam, H. J. F. Salzer et al., “Posaconazole plasma concentrations and invasive mould infections in patients with haematological malignancies,” International Journal of Antimicrobial Agents, vol. 39, no. 6, pp. 510–513, 2012. View at Publisher · View at Google Scholar · View at Scopus
  18. C. Cattaneo, A. Panzali, A. Passi et al., “Serum posaconazole levels during acute myeloid leukaemia induction therapy: correlations with breakthrough invasive fungal infections,” Mycoses, vol. 58, no. 6, pp. 362–367, 2015. View at Publisher · View at Google Scholar · View at Scopus
  19. M. J. Dolton, J. E. Ray, S. C. Chen, K. Ng, L. Pont, and A. J. McLachlan, “Multicenter study of posaconazole therapeutic drug monitoring: exposure-response relationship and factors affecting concentration,” Antimicrobial Agents Chemotherapy, vol. 50, pp. 1993–1999, 2006. View at Google Scholar
  20. H. R. Ashbee, R. A. Barnes, E. M. Johnson, M. D. Richardson, R. Gorton, and W. W. Hope, “Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the british society for medical mycology,” Journal of Antimicrobial Chemotherapy, vol. 69, no. 5, pp. 1162–1176, 2014. View at Google Scholar
  21. A. Cumpston, R. Caddell, A. Shillingburg et al., “Superior serum concentrations with posaconazole delayed-release tablets compared to suspension formulation in hematological malignancies,” Antimicrobial Agents and Chemotherapy, vol. 59, no. 8, pp. 4424–4428, 2015. View at Publisher · View at Google Scholar · View at Scopus
  22. D. S. Jung, F. P. Tverdek, and D. P. Kontoyiannis, “Switching from posaconazole suspension to tablets increases serum drug levels in leukemia patients without clinically relevant hepatotoxicity,” Antimicrobial Agents and Chemotherapy, vol. 58, no. 11, pp. 6993–6995, 2014. View at Publisher · View at Google Scholar · View at Scopus
  23. A. N. Pham, J. S. Bubalo, and J. S. Lewis, “Comparison of posaconazole serum concentrations from haematological cancer patients on posaconazole tablet and oral suspension for treatment and prevention of invasive fungal infections,” Mycoses, vol. 59, no. 4, pp. 226–233, 2016. View at Publisher · View at Google Scholar · View at Scopus
  24. U. Durani, P. K. Tosh, J. N. Barreto, L. L. Estes, P. J. Jannetto, and A. J. Tande, “Retrospective comparison of posaconazole levels in patients taking the delayed-release tablet versus the oral suspension,” Antimicrobial Agents and Chemotherapy, vol. 59, no. 8, pp. 4914–4918, 2015. View at Publisher · View at Google Scholar · View at Scopus
  25. National Cancer Institute, Common terminology criteria for adverse events (CTCAE), version 4.03, National Cancer Institute, Bethesda, Maryland, MD, USA, 2010.
  26. B. De Pauw, T. J. Walsh, J. P. Donnelly, D. A. Stevens, J. E. Edwards, T. Calandra et al., “Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group,” Clinical Infectious Diseases, vol. 46, pp. 1813–1821, 2008. View at Google Scholar
  27. M. H. Miceli, A. J. Perissinotti, C. A. Kauffman, and D. R. Couriel, “Serum posaconazole levels among haematological cancer patients taking extended release tablets is affected by body weight and diarrhoea: Single centre retrospective analysis,” Mycoses, vol. 58, no. 7, pp. 432–436, 2015. View at Publisher · View at Google Scholar · View at Scopus
  28. O. A. Cornely, R. F. Duarte, S. Haider et al., “Phase 3 pharmacokinetics and safety study of a posaconazole tablet formulation in patients at risk for invasive fungal disease,” Journal of Antimicrobial Chemotherapy, vol. 71, no. 6, pp. 718–726, 2016. View at Google Scholar