Browse > Article

Factors Affecting the Adverse Drug Reactions of Mycophenolate Mofetil  

Kim, Keum-Hi (Department of Pharmacy, Seoul National University Hospital)
Lee, Ju-Yeun (Department of Pharmacy, Seoul National University Hospital)
Park, Kyung-Ho (Department of Pharmacy, Seoul National University Hospital)
Son, In-Ja (Department of Pharmacy, Seoul National University Hospital)
Lee, Hye-Suk (Department of Pharmacy, Seoul National University Hospital)
Publication Information
Korean Journal of Clinical Pharmacy / v.20, no.2, 2010 , pp. 151-158 More about this Journal
Abstract
Therapeutic drug monitoring of Mycophenolate mofetil(MMF) has been suggested in some clinical trials, but has not been widely adopted in Korea. The purpose of this study was to analyze the withdrawal rates of MMF and determine the characteristics of the patients who experienced adverse reactions with MMF therapy and to suggest the criteria for selecting patients who need monitoring of MMF levels. We retrospectively collected data of patients who started MMF between July 2007 and June 2008. A total of 154 adult patients were included in our study. Among them, ninety seven patients discontinued MMF with 59 cases being due to adverse drug reactions. Thirty one patients required dosage reduction of MMF with twenty three cases being due to adverse reactions. Twenty six patients continued the MMF without or with mild adverse reactions. Of the 82 adverse reaction cases, hematologic adverse reactions accounted for 38 cases (46%) and gastrointestinal (GI) adverse reactions accounted for 28 cases (34%). Older age and lower serum albumin levels were significantly different characteristics between the patients who withdraw MMF due to hematological adverse reactions and those who were able to continue therapy. The group who experienced GI adverse reactions had higher MMF dosages based on body weight and lower serum albumin levels. In conclusion, the factors affecting the adverse reactions of MMF were age, serum albumin level and higher dosage, therefore therapeutic drug monitoring of MMF should be considered in these patients.
Keywords
Mycophenolate mofetil(MMF); adverse drug reactions; monitoring; factors;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Kuypers DR, de Jonge H, Naesens M, et al., Current target ranges of mycophenolic acid exposure and drugrelated adverse events: A 5-year, open-label, prospective, clinical follow-up study in renal allograft recipients. Clin Ther. 2008 Apr; 30(4): 673-683.   DOI   ScienceOn
2 The US Renal Transplant Mycophenolate Mofetil Study Group. Sollinger HW. : Mycophenolate mofetil for the prevention of acute rejection in cadaveric renal allograft recipients. Transplantation. 1995;60:225-232.   DOI   ScienceOn
3 Mourad M, Malaise J, Chaib Eddour D, et al., Correlation of mycophenolic acid pharmacokinetic parameters withside effects in kidney transplant patients treated with mycophenolate mofetil. Clin Chem 2001; 47: 188-94.
4 Shaw LM, Figurski M, Milone MC, et al., Therapeutic drug monitoring of mycophenolic acid. Clin J Am Soc Nephrol. 2007 Sep; 2(5): 1062-1072.   DOI   ScienceOn
5 Behrend M. Adverse gastrointestinal effects of mycophenolate mofetil: aetiology, incidence and manage ment. Drug Saf. 2001; 24(9): 645-663.   DOI   ScienceOn
6 Toda T, Motoki T, Kurosawa N, et al., The Relationship between dose of mycophenolate mofetil and the occurrence of cytomegalovirus infection and diarrhea in renal transplant recipients. Yakugaku Zasshi. 2005 Feb;125(2): 177-185.   DOI   ScienceOn
7 Cho E, Han D, Kim S, et al., Pharmacokinetic study of mycophenolic acid in Korean kidney transplant patients. J Clin Pharmacol. 2004; 44: 743-750.   DOI   ScienceOn
8 Le Meur Y, Buchler M, Thierry A et al., Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation. Am J Transplant. 2007; 7: 2496-2503.   DOI   ScienceOn
9 European Mycophenolate Mofetil Cooperative Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporine and corticosteroids for prevention of acute rejection. Lancet. 1995;345: 1321-1325.
10 Van Gelder T, Silva HT, de Fijter JW, et al., Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed-dose concentration-controlled trial. Transplantation. 2008 Oct 27; 86(8): 1043-51.   DOI   ScienceOn
11 The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. Transplantation. 1996;61:1029-1037.   DOI   ScienceOn
12 Hale MD, Nicholls AJ, Bullingham RE, et al., The pharmacokinetic-pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 1998; 64: 672-83.   DOI   ScienceOn
13 Knight SR, Morris PJ. Does the evidence support the use of mycophenolate mofetil therapeutic drug monitoring in clinical practice? A systematic review. Transplantation. 2008; 85: 1675-1685.   DOI   ScienceOn
14 Gaston RS, Kaplan B, Shah T, et al., Fixed- or controlleddose mycophenolate mofetil with standard- or reduceddose calcineurin inhibitors: the Opticept trial. Am J Transplant. 2009 Jul; 9(7): 1607-19.   DOI   ScienceOn