Monitoring of mycophenolic acid predose concentrations in the maintenance phase more than one year after renal transplantation

Therapeutic Drug Monitoring

Volumn 33, Issue 3, 2011, Pages 295-302

  Miura, Masatomo ^a   Niioka, Takenori ^a   Kato, Shoutaro ^a   Kagaya, Hideaki ^a   Saito, Mitsuru ^b   Habuchi, Tomonori ^b   Satoh, Shigeru ^b  

^a AKITA UNIVERSITY HOSPITAL   (Japan)

^b AKITA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

AUC; Mycophenolic acid; Predose concentration; Renal transplantation; Therapeutic drug monitoring

Indexed keywords

BREAST CANCER RESISTANCE PROTEIN; GLUCURONOSYLTRANSFERASE 1A1; GLUCURONOSYLTRANSFERASE 1A9; GLUCURONOSYLTRANSFERASE 2B7; MEMBRANE PROTEIN; MEMBRANE PROTEIN ABCC2; MEMBRANE PROTEIN SLCO1B3; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; TACROLIMUS; UNCLASSIFIED DRUG;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CREATININE CLEARANCE; DRUG BLOOD LEVEL; DRUG MONITORING; FEMALE; GENOTYPE; HUMAN; KIDNEY TRANSPLANTATION; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MALE; PREDOSE CONCENTRATION; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY;

ADULT; AGE FACTORS; AREA UNDER CURVE; DRUG MONITORING; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MYCOPHENOLIC ACID; TACROLIMUS; TIME FACTORS;

EID: 80051721961     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e3182197e38     Document Type: Article

References (37)

1. Roth D, Colona J, Burke GW, et al. Primary immunosuppression with tacrolimus and mycophenolate mofetil for renal allograft recipients. Transplantation. 1998;65:248-252. (Pubitemid 28099219)
2. Squifflet JP, Backman L, Claesson K, et al. Dose optimization of mycophenolate mofetil when administered with a low dose of tacrolimus in cadaveric renal transplant recipients. Transplantation. 2001;72:63-69. (Pubitemid 32652507)
3. Kuypers DR, Le Meur Y, Cantarovich M, et al. Consensus report on therapeutic drug monitoring of mycophenolic acid in solid organ transplantation. Clin J Am Soc Nephrol. 2010;5:341-358.
4. Shaw LM, Kaplan B, DeNofrio D, et al. Pharmacokinetics and concentration-control investigations of mycophenolic acid in adults after transplantation. Ther Drug Monit. 2000;22:14-19. (Pubitemid 30083089)
5. Oellerich M, Shipkova M, Schutz E, et al. Pharmacokinetic and metabolic investigations of mycophenolic acid in pediatric patients after renal transplantation: implications for therapeutic drug monitoring. German Study Group on Mycophenolate Mofetil Therapy in Pediatric Renal Transplant Recipients. Ther Drug Monit. 2000;22:20-26. (Pubitemid 30083090)
6. Hale MD, Nicholls AJ, Bullingham RES, et al. The pharmacokinetic- pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther. 1998;64:672-683. (Pubitemid 29011387)
7. Shaw LM, Korecka M, DeNofrio D, et al. Pharmacokinetic, pharmacodynamic, and outcome investigations as the basis for mycophenolic acid therapeutic drug monitoring in renal transplant patients. Clin Biochem. 2001;34:17-22. (Pubitemid 32178501)
8. Miura M, Satoh S, Niioka T, et al. Limited sampling strategy for simultaneous estimation of the area under the concentration-time curve of tacrolimus and mycophenolic acid in adult renal transplant recipients. Ther Drug Monit. 2008;30:52-59. (Pubitemid 351161099)
9. Miura M, Satoh S, Niioka T, et al. Early phase limited sampling strategy characterizing tacrolimus and mycophenolic acid pharmacokinetics adapted to the maintenance phase of renal transplant patients. Ther Drug Monit. 2009;31:467-474.
10. Cox VC, Ensom MH. Mycophenolate mofetil for solid organ transplantation: does the evidence support the need for clinical pharmacokinetic monitoring? Ther Drug Monit. 2003;25:137-157. (Pubitemid 36373421)
11. Bullingham RE, Nicholls AJ, Kamm BR. Clinical pharmacokinetics of mycophenolate mofetil. Clin Pharmacokinet. 1998;34:429-455. (Pubitemid 28273453)
12. Jusko WJ, Thomson AW, Fung J, et al. Consensus document: therapeutic monitoring of tacrolimus (FK-506). Ther Drug Monit. 1995;17: 606-614.
13. Pawinski T, Hale M, Korecka M, et al. Limited sampling strategy for the estimation of mycophenolic acid area under the curve in adult renal transplant patients treated with concomitant tacrolimus. Clin Chem. 2002; 48:1497-1504. (Pubitemid 34925784)
14. Tett SE, Saint-Marcoux F, Staatz CE, et al. Mycophenolate-clinical pharmacokinetics, including effects of formulation and different methods of measuring exposure. Transplant Rev. 2011;25:47-57.
15. Kagaya H, Inoue K, Miura M, et al. Quantification and 24-hour monitoring of mycophenolic acid by high-performance liquid chromatography in Japanese renal transplant recipients. Yakugaku Zasshi. 2006; 126:1357-1362. (Pubitemid 46089896)
16. Ando Y, Saka H, Ando M, et al. Polymorphisms of UDP- glucuronosyltransferase gene and irinotecan toxicity: a pharmacogenetic analysis. Cancer Res. 2000;60:6921-6926. (Pubitemid 32059164)
17. Lin GF, Guo WC, Chen JG, et al. An association of UDPglucuronosyltransferase 2B7 C802T (His268Tyr) polymorphism with bladder cancer in benzidine-exposed workers in China. Toxicol Sci. 2005; 85:502-506.
18. Girard H, Villeneuve L, Court MH, et al. The novel UGT1A9 intronic I399 polymorphism appears as a predictor of 7-ethyl-10-hydroxycamptothecin glucuronidation levels in the liver. Drug Metab Dispos. 2006;34: 1220-1228.
19. Nozawa T, Nakajima M, Tamai I, et al. Genetic polymorphisms of human organic anion transporters OATP-C (SLC21A6) and OATP-B (SLC21A9): allele frequencies in the Japanese population and functional analysis. J Pharmacol Exp Ther. 2002;302:804-813. (Pubitemid 34787251)
20. Tsujimoto M, Hirata S, Dan Y, et al. Polymorphisms and linkage disequilibrium of the OATP8 (OATP1B3) gene in Japanese subjects. Drug Metab Pharmacokinet. 2006;21:165-169.
21. Rau T, Erney B, Gores R, et al. High-dose methotrexate in pediatric acute lymphoblastic leukemia: impact of ABCC2 polymorphisms on plasma concentrations. Clin Pharmacol Ther. 2006;80:468-476. (Pubitemid 44737489)
22. Kobayashi D, Ieiri I, Hirota T, et al. Functional assessment of ABCG2 (BCRP) gene polymorphisms to protein expression in human placenta. Drug Metab Dispos. 2005;33:94-101. (Pubitemid 40023519)
23. van Gelder T, Le Meur Y, Shaw LM, et al. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit. 2006;28: 145-154. (Pubitemid 44314941)
24. Borrows R, Chusney G, Loucaidou M, et al. Mycophenolic acid 12-h trough level monitoring in renal transplantation: association with acute rejection and toxicity. Am J Transplant. 2006;6:121-128. (Pubitemid 43382210)
25. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Pharmacokinet. 2007;46:13-58. (Pubitemid 46091591)
26. Lee S, Shin M, Kim E, et al. Mycophenolic acid trough level measurements and clinical outcomes in kidney transplantation recipients on a fixed dose (1.5 g/d) of mycophenolate mofetil in Korea. Transplant Proc. 2010;42: 793-796.
27. Guillet BA, Simon NS, Purgus R, et al. Population pharmacokinetics analysis of mycophenolic acid in adult kidney transplant patients with chronic graft dysfunction. Ther Drug Monit. 2010;32:427-432.
28. van Hest RM, van Gelder T, Vulto AG, et al. Population pharmacokinetics of mycophenolic acid in renal transplant recipients. Clin Pharmacokinet. 2005;44:1083-1096. (Pubitemid 41356393)
29. van Hest RM, Mathot RA, Pescovitz MD, et al. Explaining variability in mycophenolic acid exposure to optimize mycophenolate mofetil dosing: a population pharmacokinetic meta-analysis of mycophenolic acid in renal transplant recipients. J Am Soc Nephrol. 2006;17:871-880.
30. Kuypers DR, Naesens M, Vermeire S, et al. The impact of uridine diphosphate-glucuronosyltransferase 1A9 (UGT1A9) gene promoter region single-nucleotide polymorphisms T-275A and C-2152T on early mycophenolic acid dose-interval exposure in de novo renal allograft recipients. Clin Pharmacol Ther. 2005;78:351-361. (Pubitemid 41393670)
31. van Schaik RH, van Agteren M, de Fijter JW, et al. UGT1A9 -275T.A/ -2152C.T polymorphisms correlate with low MPA exposure and acute rejection in MMF/tacrolimus-treated kidney transplant patients. Clin Pharmacol Ther. 2009;86:319-327.
32. Picard N, Yee SW,Woillard JB, et al. The role of organic anion-transporting polypeptides and their common genetic variants in mycophenolic acid pharmacokinetics. Clin Pharmacol Ther. 2010;87:100-108.
33. Barraclough KA, Isbel NM, Staatz CE. Evaluation of the mycophenolic acid exposure estimation methods used in the APOMYGERE, FDCC, and Opticept trials. Transplantation. 2010;90:44-51.
34. van Gelder T, Shaw LM. The rationale for and limitations of therapeutic drug monitoring for mycophenolate mofetil in transplantation. Transplantation. 2005;80:S244-S253. (Pubitemid 41552911)
35. Gaston RS, Kaplan B, Shah T, et al. Fixed- or controlled-dose mycophenolate mofetil with standard- or reduced-dose calcineurin inhibitors: the Opticept trial. Am J Transplant. 2009;9:1607-1619.
36. 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;86:1043-1051.
37. van Gelder T. Mycophenolate blood level monitoring: recent progress. Am J Transplant. 2009;9:1495-1499.