Voriconazole-related severe adverse events: Clinical application of therapeutic drug monitoring in Korean patients

International Journal of Infectious Diseases

Volumn 15, Issue 11, 2011, Pages

  Kim, Si Hyun ^a   Yim, Dong Seok ^a   Choi, Su Mi ^a   Kwon, Jae Cheol ^a   Han, Seunghoon ^a   Lee, Dong Gun ^a   Park, Chulmin ^b   Kwon, Eun Young ^b   Park, Sun Hee ^a   Choi, Jung Hyun ^a   Yoo, Jin Hong ^a  

^a The Catholic University of Korea   (South Korea)

^b The Catholic University of Korea   (South Korea)

Author keywords

Adverse drug event; Korea; Therapeutic drug monitoring; Voriconazole

Indexed keywords

CYTOCHROME P450 2C19; PROTON PUMP INHIBITOR; VORICONAZOLE;

ADULT; AGE DISTRIBUTION; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BRAIN TOXICITY; CLINICAL ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GENOTYPE; HEART VENTRICLE TACHYCARDIA; HEMATOLOGIC MALIGNANCY; HUMAN; INVASIVE ASPERGILLOSIS; KOREA; LOADING DRUG DOSE; MALE; OBSERVATIONAL STUDY; PROSPECTIVE STUDY; RECEIVER OPERATING CHARACTERISTIC; REFERENCE VALUE; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; SEX DIFFERENCE; SIDE EFFECT; SUPRAVENTRICULAR TACHYCARDIA;

ADULT; ALLELES; ANTIFUNGAL AGENTS; ARYL HYDROCARBON HYDROXYLASES; ASPERGILLOSIS; ASPERGILLUS; DRUG MONITORING; FEMALE; GENOTYPE; HEMATOLOGIC NEOPLASMS; HUMANS; IMMUNOCOMPROMISED HOST; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PYRIMIDINES; REPUBLIC OF KOREA; RISK FACTORS; TRIAZOLES; YOUNG ADULT;

EID: 80054926702     PISSN: 12019712     EISSN: 18783511     Source Type: Journal    
DOI: 10.1016/j.ijid.2011.06.004     Document Type: Article

References (39)

1. Marr K.A., Carter R.A., Crippa F., Wald A., Corey L. Epidemiology and outcome of mould infections in hematopoietic stem cell transplant recipients. Clin Infect Dis 2002, 34:909-917.
2. Wald A., Leisenring W., van Burik J.A., Bowden R.A. Epidemiology of Aspergillus infections in a large cohort of patients undergoing bone marrow transplantation. J Infect Dis 1997, 175:1459-1466.
3. Yoo J.H., Lee D.G., Choi S.M., Choi J.H., Park Y.H., Kim Y.J., et al. Infectious complications and outcomes after allogeneic hematopoietic stem cell transplantation in Korea. Bone Marrow Transplant 2004, 34:497-504.
4. Walsh T.J., Anaissie E.J., Denning D.W., Herbrecht R., Kontoyiannis D.P., Marr K.A., et al. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis 2008, 46:327-360.
5. Herbrecht R., Denning D.W., Patterson T.F., Bennett J.E., Greene R.E., Oestmann J.W., et al. Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis. N Engl J Med 2002, 347:408-415.
6. Paterson D.L., Singh N. Invasive aspergillosis in transplant recipients. Medicine (Baltimore) 1999, 78:123-138.
7. Patterson T.F. Aspergillus species. Principles and practice of infectious diseases 2010, 3241-3255. Churchill Livingstone Elsevier, Philadelphia. 7th ed. G.L. Mandell, J.E. Bennett, R. Dolin (Eds.).
8. Thompson G.R., Lewis J.S. Pharmacology and clinical use of voriconazole. Expert Opin Drug Metab Toxicol 2010, 6:83-94.
9. Scherpbier H.J., Hilhorst M.I., Kuijpers T.W. Liver failure in a child receiving highly active antiretroviral therapy and voriconazole. Clin Infect Dis 2003, 37:828-830.
10. Imhof A., Schaer D.J., Schanz U., Schwarz U. Neurological adverse events to voriconazole: evidence for therapeutic drug monitoring. Swiss Med Wkly 2006, 136:739-742.
11. Pascual A., Calandra T., Bolay S., Buclin T., Bille J., Marchetti O. Voriconazole therapeutic drug monitoring in patients with invasive mycoses improves efficacy and safety outcomes. Clin Infect Dis 2008, 46:201-211.
12. De Pauw B., Walsh T.J., Donnelly J.P., Stevens D.A., Edwards J.E., Calandra T., 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. Clin Infect Dis 2008, 46:1813-1821.
13. Bruggemann R.J., Alffenaar J.W., Blijlevens N.M., Billaud E.M., Kosterink J.G., Verweij P.E., Burger D.M. Clinical relevance of the pharmacokinetic interactions of azole antifungal drugs with other coadministered agents. Clin Infect Dis 2009, 48:1441-1458.
14. Pasqualotto A.C., Xavier M.O., Andreolla H.F., Linden R. Voriconazole therapeutic drug monitoring: focus on safety. Expert Opin Drug Saf 2010, 9:125-137.
15. Andes D., Pascual A., Marchetti O. Antifungal therapeutic drug monitoring: established and emerging indications. Antimicrob Agents Chemother 2009, 53:24-34.
16. Cronin S., Chandrasekar P.H. Safety of triazole antifungal drugs in patients with cancer. J Antimicrob Chemother 2010, 65:410-416.
17. Common terminology criteria for adverse events v3.0. Bethesda, MD: National Cancer Institute; 2006.
18. Naranjo C.A., Busto U., Sellers E.M., Sandor P., Ruiz I., Roberts E.A., et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981, 30:239-245.
19. Khoschsorur G., Fruehwirth F., Zelzer S. Isocratic high-performance liquid chromatographic method with ultraviolet detection for simultaneous determination of levels of voriconazole and itraconazole and its hydroxy metabolite in human serum. Antimicrob Agents Chemother 2005, 49:3569-3571.
20. Dixon S.C., Horti J., Guo Y., Reed E., Figg W.D. Methods for extracting and amplifying genomic DNA isolated from frozen serum. Nat Biotechnol 1998, 16:91-94.
21. Goldstein J.A., Blaisdell J. Genetic tests which identify the principal defects in CYP2C19 responsible for the polymorphism in mephenytoin metabolism. Methods Enzymol 1996, 272:210-218.
22. De Morais S.M., Wilkinson G.R., Blaisdell J., Meyer U.A., Nakamura K., Goldstein J.A. Identification of a new genetic defect responsible for the polymorphism of (S)-mephenytoin metabolism in Japanese. Mol Pharmacol 1994, 46:594-598.
23. Bull S.B., Mak C., Greenwood C.M. A modified score function estimator for multinomial logistic regression in small samples. Comput Stat Data Anal 2002, 39:57.
24. Mickey R.M., Greenland S. The impact of confounder selection criteria on effect estimation. Am J Epidemiol 1989, 129:125-137.
25. Purkins L., Wood N., Ghahramani P., Greenhalgh K., Allen M.J., Kleinermans D. Pharmacokinetics and safety of voriconazole following intravenous-to-oral-dose escalation regimens. Antimicrob Agents Chemother 2002, 46:2546-2553.
26. Tan K., Brayshaw N., Tomaszewski K., Troke P., Wood N. Investigation of the potential relationships between plasma voriconazole concentrations and visual adverse events or liver function test abnormalities. J Clin Pharmacol 2006, 46:235-243.
27. Ueda K., Nannya Y., Kumano K., Hangaishi A., Takahashi T., Imai Y., Kurokawa M. Monitoring trough concentration of voriconazole is important to ensure successful antifungal therapy and to avoid hepatic damage in patients with hematological disorders. Int J Hematol 2009, 89:592-599.
28. Boyd A.E., Modi S., Howard S.J., Moore C.B., Keevil B.G., Denning D.W. Adverse reactions to voriconazole. Clin Infect Dis 2004, 39:1241-1244.
29. Matsumoto K., Ikawa K., Abematsu K., Fukunaga N., Nishida K., Fukamizu T., et al. Correlation between voriconazole trough plasma concentration and hepatotoxicity in patients with different CYP2C19 genotypes. Int J Antimicrob Agents 2009, 34:91-94.
30. FDA Antiviral Drugs Advisory Committee. Briefing document for voriconazole (oral and intravenous formulations). Silver Spring MD: US Food and Drug Administration; 2001.
31. Philips J.A., Marty F.M., Stone R.M., Koplan B.A., Katz J.T., Baden L.R. Torsades de pointes associated with voriconazole use. Transpl Infect Dis 2007, 9:33-36.
32. Reams G.P., Lau A., Messina C., Villarreal D., Bauer J.H. Efficacy, electrocardiographic and renal effects of intravenous diltiazem for essential hypertension. Am J Cardiol 1987, 60:78-84.
33. Shenasa M., Kus T., Fromer M., LeBlanc R.A., Dubuc M., Nadeau R. Effect of intravenous and oral calcium antagonists (diltiazem and verapamil) on sustenance of atrial fibrillation. Am J Cardiol 1988, 62:403-407.
34. Linares M.J., Charriel G., Solis F., Rodriguez F., Ibarra A., Casal M. Susceptibility of filamentous fungi to voriconazole tested by two microdilution methods. J Clin Microbiol 2005, 43:250-253.
35. Mallie M., Bastide J.M., Blancard A., Bonnin A., Bretagne S., Cambon M., et al. In vitro susceptibility testing of Candida and Aspergillus spp to voriconazole and other antifungal agents using Etest: results of a French multicentre study. Int J Antimicrob Agents 2005, 25:321-328.
36. Denning D.W., Ribaud P., Milpied N., Caillot D., Herbrecht R., Thiel E., et al. Efficacy and safety of voriconazole in the treatment of acute invasive aspergillosis. Clin Infect Dis 2002, 34:563-571.
37. Goodwin M.L., Drew R.H. Antifungal serum concentration monitoring: an update. J Antimicrob Chemother 2008, 61:17-25.
38. Trifilio S., Ortiz R., Pennick G., Verma A., Pi J., Stosor V., et al. Voriconazole therapeutic drug monitoring in allogeneic hematopoietic stem cell transplant recipients. Bone Marrow Transplant 2005, 35:509-513.
39. Ikeda Y., Umemura K., Kondo K., Sekiguchi K., Miyoshi S., Nakashima M. Pharmacokinetics of voriconazole and cytochrome P450 2C19 genetic status. Clin Pharmacol Ther 2004, 75:587-588.