Posaconazole exposure-response relationship: Evaluating the utility of therapeutic drug monitoring

Antimicrobial Agents and Chemotherapy

Volumn 56, Issue 6, 2012, Pages 2806-2813

  Dolton, Michael J ^a   Ray, John E ^b   Marriott, Deborah ^b   McLachlan, Andrew J ^a,c  

^a UNIVERSITY OF SYDNEY   (Australia)

^b ST VINCENT S HOSPITAL   (Australia)

^c ANZAC Research Institute   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ITRACONAZOLE; POSACONAZOLE; VORICONAZOLE;

AREA UNDER THE CURVE; COCCIDIOIDOMYCOSIS; COST OF ILLNESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG EXPOSURE; DRUG MONITORING; DRUG SOLUBILITY; EVALUATION; FAT INTAKE; GASTROINTESTINAL DISEASE; HUMAN; LUNG ASPERGILLOSIS; MORTALITY; MYCOSIS; NONHUMAN; PRIORITY JOURNAL; SHORT SURVEY; TREATMENT OUTCOME; TREATMENT RESPONSE;

ANIMALS; ANTIFUNGAL AGENTS; DRUG MONITORING; HUMANS; MYCOSES; TRIAZOLES;

EID: 84861116449     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.05900-11     Document Type: Short Survey

References (68)

1. Andes D, et al. 2004. Pharmacodynamics of a new triazole, posaconazole, in a murine model of disseminated candidiasis. Antimicrob. Agents Chemother. 48:137-142. (Pubitemid 38040189)
2. Andes D, Pascual A, Marchetti O. 2009. Antifungal therapeutic drug monitoring: established and emerging indications. Antimicrob. Agents Chemother. 53:24 -34.
3. Bryant AM, Slain D, Cumpston A, Craig M. 2011. A marketing evaluation of posaconazole plasma concentrations in neutropenic patients with haematological malignancy receiving posaconazole prophylaxis. Int. J. Antimicrob. Agents 37:266 -269.
4. Campoli P, et al. 2011. Concentration of antifungal agents within host cell membranes: a new paradigm governing the efficacy of prophylaxis. Antimicrob. Agents Chemother. 55:5732-5739.
5. Catanzaro A, et al. 2007. Safety, tolerance, and efficacy of posaconazole therapy in patients with nonmeningeal disseminated or chronic pulmonary coccidioidomycosis. Clin. Infect. Dis. 45:562-568. (Pubitemid 47328635)
6. Chhun S, et al. 2007. Simultaneous quantification of voriconazole and posaconazole in human plasma by high-performance liquid chromatography with ultra-violet detection. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 852:223-228. (Pubitemid 46839210)
7. Conte JE, Jr, Devoe C, Little E, Golden JA. 2010. Steady-state intrapulmonary pharmacokinetics and pharmacodynamics of posaconazole in lung transplant recipients. Antimicrob. Agents Chemother. 54:3609 -3613.
8. Conte JE, Jr, et al. 2009. Intrapulmonary pharmacokinetics and pharmacodynamics of posaconazole at steady state in healthy subjects. Antimicrob. Agents Chemother. 53:703-707.
9. Cornely OA, et al. 2007. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. N. Engl. J. Med. 356:348 -359.
10. Cornely OA, Ullmann AJ. 2011. Lack of evidence for exposure-response relationship in the use of posaconazole as prophylaxis against invasive fungal infections. Clin. Pharmacol. Ther. 89:351-352.
11. Courtney R, Pai S, Laughlin M, Lim J, Batra V. 2003. Pharmacokinetics, safety, and tolerability of oral posaconazole administered in single and multiple doses in healthy adults. Antimicrob. Agents Chemother. 47: 2788-2795. (Pubitemid 37040249)
12. Courtney R, et al. 2005. Posaconazole pharmacokinetics, safety, and tolerability in subjects with varying degrees of chronic renal disease. J. Clin. Pharmacol. 45:185-192. (Pubitemid 40490442)
13. Courtney R, Wexler D, Radwanski E, Lim J, Laughlin M. 2004. Effect of food on the relative bioavailability of two oral formulations of posaconazole in healthy adults. Br. J. Clin. Pharmacol. 57:218 -222.
14. de Pauw B, et al. 2008. 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. Clin. Infect. Dis. 46:1813-1821.
15. Dodds Ashley ES, et al. 2009. Pharmacokinetics of posaconazole administered orally or by nasogastric tube in healthy volunteers. Antimicrob. Agents Chemother. 53:2960 -2964.
16. Eiden C, et al. 2012. Therapeutic drug monitoring of posaconazole in hematology adults under posaconazole prophylaxis: influence of food intake. Eur. J. Clin. Microbiol. Infect. Dis. 31:161-167.
17. European Medicines Agency. 2010. European Public Assessment Reports summary for the public: Noxafil (posaconazole). European Medicines Agency, London, United Kingdom. http://www.ema.europa.eu/ema/index.jsp?curl=pages/ medicines/human/medicines/000610/human-med-000937.jsp&murl=menus/medicines/ medicines.jsp&mid=WC0b01ac058001d125.
18. European Medicines Agency. 2005. Noxafil: EPAR-scientific discussion. European Medicines Agency, London, United Kingdom. http://www.ema.europa.eu/ docs/en-GB/document-library/EPAR---Scientific-Discussion/human/000610/ WC500037781.pdf.
19. European Medicines Agency. 2011. Noxafil. EPAR annex 1. Summary of product characteristics. European Medicines Agency, London, United Kingdom. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Product-Information/ human/000610/WC500037784.pdf.
20. Ezzet F, et al. 2005. Oral bioavailability of posaconazole in fasted healthy subjects: comparison between three regimens and basis for clinical dosage recommendations. Clin. Pharmacokinet. 44:211-220. (Pubitemid 40188942)
21. Farowski F, et al. 2010. Intracellular concentrations of posaconazole in different compartments of peripheral blood. Antimicrob. Agents Chemother. 54:2928 -2931.
22. Felton TW, et al. 2010. Efficacy and safety of posaconazole for chronic pulmonary aspergillosis. Clin. Infect. Dis. 51:1383-1391.
23. Ghosal A, et al. 2004. Identification of human UDP- glucuronosyltransferase enzyme(s) responsible for the glucuronidation of posaconazole (Noxafil). Drug Metab. Dispos. 32:267-271. (Pubitemid 38176945)
24. Goodwin ML, Drew RH. 2008. Antifungal serum concentration monitoring: an update. J. Antimicrob. Chemother. 61:17-25.
25. Gordien J-B, et al. 2009. Simultaneous determination of five systemic azoles in plasma by high-performance liquid chromatography with ultraviolet detection. J. Pharm. Biomed. Anal. 50:932-938.
26. Groll AH, et al. 2000. Pharmacokinetics and pharmacodynamics of posaconazole (SCH 56592) in a neutropenic animal model of invasive pulmonary aspergillosis. Abstr. 40th Intersci. Conf. Antimicrob. Agents Chemother., Toronto, Canada, p 385. American Society for Microbiology, Washington, DC.
27. Gubbins PO, et al. 2006. Pharmacokinetics and safety of oral posaconazole in neutropenic stem cell transplant recipients. Antimicrob. Agents Chemother. 50:1993-1999. (Pubitemid 43807517)
28. Hadjiliadis D, et al. 2003. Gastroesophageal reflux disease in lung transplant recipients. Clin. Transplant. 17:363-368. (Pubitemid 36958199)
29. Heinz WJ, et al. 2011. Relevance of timing for the determination of posaconazole plasma concentrations. Antimicrob. Agents Chemother. 55: 3621-3623.
30. Howard SJ, et al. 2011. Pharmacokinetics and pharmacodynamics of posaconazole for invasive pulmonary aspergillosis: clinical implications for antifungal therapy. J. Infect. Dis. 203:1324 -1332.
31. Jang SH, Colangelo PM, Gobburu JVS. 2010. Exposure-response of posaconazole used for prophylaxis against invasive fungal infections: evaluating the need to adjust doses based on drug concentrations in plasma. Clin. Pharmacol. Ther. 88:115-119.
32. Kahle K, et al. 2009. Simultaneous determination of voriconazole and posaconazole concentrations in human plasma by high-performance liquid chromatography. Antimicrob. Agents Chemother. 53:3140 -3142.
33. Kohl V, et al. 2010. Factors influencing pharmacokinetics of prophylactic posaconazole in patients undergoing allogeneic stem cell transplantation. Antimicrob. Agents Chemother. 54:207-212.
34. Krishna G, et al. 2008. Pharmacokinetics of oral posaconazole in neutropenic patients receiving chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome. Pharmacotherapy 28:1223-1232.
35. Krishna G, et al. 2009. Effect of varying amounts of a liquid nutritional supplement on the pharmacokinetics of posaconazole in healthy volunteers. Antimicrob. Agents Chemother. 53:4749-4752.
36. Krishna G, Martinho M, Chandrasekar P, Ullmann AJ, Patino H. 2007. Pharmacokinetics of oral posaconazole in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease. Pharmacotherapy 27:1627-1636.
37. Krishna G, Martinho MLM, O'Mara E. 2011. Improved bioavailability of posaconazole (POS) new tablets and capsule formulations relative to oral suspension. Abstr. 51st Intersci. Conf. Antimicrob. Agents Chemother., Chicago, IL, abstr A2-573 American Society for Microbiology, Washington, DC.
38. Krishna G, Martinho MLM, Preston RA, O'Mara E. 2011. Posaconazole (POS) multiple dose pharmacokinetics (PK) and safety in healthy volunteers from a new solid oral tablet formulation. Abstr. 51st Intersci. Conf. Antimicrob. Agents Chemother., Chicago, IL, abstr A2-573. American Society for Microbiology, Washington, DC.
39. Krishna G, Moton A, Ma L, Medlock MM, McLeod J. 2009. Pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers. Antimicrob. Agents Chemother. 53:958 -966.
40. Krishna G, Parsons A, Kantesaria B, Mant T. 2007. Evaluation of the pharmacokinetics of posaconazole and rifabutin following coadministration to healthy men. Curr. Med. Res. Opin. 23:545-552. (Pubitemid 46456902)
41. Krishna G, Sansone-Parsons A, Kantesaria B. 2007. Drug interaction assessment following concomitant administration of posaconazole and phenytoin in healthy men. Curr. Med. Res. Opin. 23:1415-1422. (Pubitemid 46998449)
42. Lebeaux D, et al. 2009. Therapeutic drug monitoring of posaconazole: a monocentric study with 54 adults. Antimicrob. Agents Chemother. 53: 5224-5229.
43. Li Y, Theuretzbacher U, Clancy CJ, Nguyen MH, Derendorf H. 2010. Pharmacokinetic/pharmacodynamic profile of posaconazole. Clin. Pharmacokinet. 49:379 -396.
44. Lignell A, Löwdin E, Cars O, Chryssanthou E, Sjölin J. 2011. Posaconazole in human serum: a greater pharmacodynamic effect than predicted by the non-protein-bound serum concentration. Antimicrob. Agents Chemother. 55:3099 -3104.
45. Lin SJ, Schranz J, Teutsch SM. 2001. Aspergillosis case-fatality rate: systematic review of the literature. Clin. Infect. Dis. 32:358 -366.
46. Lipp H-P. 2010. Clinical pharmacodynamics and pharmacokinetics of the antifungal extended-spectrum triazole posaconazole: an overview. Br. J. Clin. Pharmacol. 70:471- 480.
47. Mavridou E, Bruggemann RJM, Melchers WJG, Mouton JW, Verweij PE. 2010. Efficacy of posaconazole against three clinical Aspergillus fumigatus isolates with mutations in the cyp51A gene. Antimicrob. Agents Chemother. 54:860-865.
48. Merck & Co. 2010. Noxafil US Prescribing Information, revised September
49. Merck & Co, Whitehouse Station, NJ. http://www.spfiles.com/pinoxafil. pdf.
50. Moton A, Krishna G, Wang Z. 2009. Tolerability and safety profile of posaconazole: evaluation of 18 controlled studies in healthy volunteers. J. Clin. Pharm. Ther. 34:301-311.
51. Müller C, Arndt M, Queckenberg C, Cornely OA, Theisohn M. 2006. HPLC analysis of the antifungal agent posaconazole in patients with haematological diseases. Mycoses 49(Suppl. 1):17-22.
52. Nagappan V, Deresinski S. 2007. Reviews of anti-infective agents: posaconazole: a broad-spectrum triazole antifungal agent. Clin. Infect. Dis. 45:1610 -1617.
53. Neubauer WC, et al. 2010. Therapeutic drug monitoring of posaconazole in hematology patients: experience with a new high-performance liquid chromatography-based method. Antimicrob. Agents Chemother. 54: 4029-4032.
54. Pfaller MA, Pappas PG, Wingard JR. 2006. Invasive fungal pathogens: current epidemiological trends. Clin. Infect. Dis. 43(Suppl 1):S3-S14. (Pubitemid 44078892)
55. Ray J, Campbell L, Rudham S, Nguyen Q, Marriott D. 2011. Posaconazole plasma concentrations in critically ill patients. Ther. Drug Monit. 33:387-392.
56. Sabatelli F, et al. 2006. In vitro activities of posaconazole, fluconazole, itraconazole, voriconazole, and amphotericin B against a large collection of clinically important molds and yeasts. Antimicrob. Agents Chemother. 50:2009 -2015.
57. Schering-Plough. 2011. Pharmacokinetics, safety, and tolerability of intravenous posaconazole solution followed by oral posaconazole suspension in subjects at high risk for invasive fungal infections (study P05520AM1). NLM identifier NCT01075984. U.S. National Library of Medicine, Bethesda, MD. http://clinicaltrials.gov/ct2/show/NCT01075984.
58. Shen JX, Krishna G, Hayes RN. 2007. A sensitive liquid chromatography and mass spectrometry method for the determination of posaconazole in human plasma. J. Pharm. Biomed. Anal. 43:228 -236.
59. Shields RK, et al. 2011. Posaconazole serum concentrations among cardiothoracic transplant recipients: factors impacting trough levels and correlation with clinical response to therapy. Antimicrob. Agents Chemother. 55:1308 -1311.
60. Sinnollareddy M, Peake SL, Roberts MS, Lipman J, Roberts JA. 2012. Using pharmacokinetics and pharmacodynamics to optimise dosing of antifungal agents in critically ill patients: a systematic review. Int. J. Antimicrob. Agents 39:1-10.
61. Thompson GR, et al. 2009. Posaconazole therapeutic drug monitoring: a reference laboratory experience. Antimicrob. Agents Chemother. 53: 2223-2224.
62. Torres HA, Hachem RY, Chemaly RF, Kontoyiannis DP, Raad II. 2005. Posaconazole: a broad-spectrum triazole antifungal. Lancet Infect. Dis. 5:775-785.
63. Ullmann AJ, et al. 2006. Pharmacokinetics, safety, and efficacy of posaconazole in patients with persistent febrile neutropenia or refractory invasive fungal infection. Antimicrob. Agents Chemother. 50:658-666. (Pubitemid 43190980)
64. Ullmann AJ, et al. 2007. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. N. Engl. J. Med. 356:335-347. (Pubitemid 46148776)
65. U.S. Food and Drug Administration. 2008. Noxafil (posaconazole) oral suspension. U.S. Food and Drug Administration, Silver Spring, MD. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2006/022027-noxafil-toc.cfm.
66. Walravens J, et al. 2011. Effect of pH and Comedication on gastrointestinal absorption of posaconazole: monitoring of intraluminal and plasma drug concentrations. Clin. Pharmacokinet. 50:725-734.
67. Walsh TJ, et al. 2007. Treatment of invasive aspergillosis with posaconazole in patients who are refractory to or intolerant of conventional therapy: an externally controlled trial. Clin. Infect. Dis. 44:2-12. (Pubitemid 44968977)
68. Wilson LS, et al. 2002. The direct cost and incidence of systemic fungal infections. Value Health 5:26 -34.