Therapeutic drug monitoring of mycophenolic acid

Clinical Journal of the American Society of Nephrology

Volumn 2, Issue 5, 2007, Pages 1062-1072

  Shaw, Leslie M ^a   Figurski, Michal ^a   Milone, Michael C ^a   Trofe, Jennifer ^a   Bloom, Roy D ^a  

^a HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MYCOPHENOLIC ACID;

DRUG MONITORING; HUMAN; KIDNEY TRANSPLANTATION; REVIEW;

DRUG MONITORING; HUMANS; KIDNEY TRANSPLANTATION; MYCOPHENOLIC ACID;

EID: 34548820750     PISSN: 15559041     EISSN: 1555905X     Source Type: Journal    
DOI: 10.2215/CJN.03861106     Document Type: Article

References (69)

1. Meier-Kriesche H-U, Li S, Gruessner RW, Fung JJ, Bustami RT, Barr ML, Leichtman AB: Immunosuppression: Evolution in practice and trends. Am J Transplant 6: 1111-1131, 2006
2. Arns W, Breuers S, Choulhury S, Taccard G, Lee J, Binder V Roettele J, Schmouder R: Enteric-coated mycophenolate sodium delivers bioequivalent MPA exposure compared with mycophenolate mofetil. Clin Transplant 19: 199-206, 2005
3. Carr SF, Papp E, Wu JC, Natsumeda Y: Characterization of human type I and II IMP dehydrogenases. J Biol Chem 268:27286-27290, 1993
4. Ransom JT: The mechanism of action of mycophenolate mofetil. Ther Drug Monit 17: 681-684, 1995
5. Meiser BM, Pfeiffer M, Schmidt D, et al.: Combination therapy with tacrolimus and mycophenolate mofetil following cardiac transplantation: Importance of mycophenolic acid therapeutic drug monitoring. J Heart Lung Transplant 18: 143-149, 1999
6. Shaw LM, Holt DW, Oellerich M, Meiser B, van Gelder T: Current issues in therapeutic drug monitoring of mycophenolic acid. Ther Drug Monit 23: 305-315, 2001
7. Bennett WM: Immunosuppression with mycophenolic acid: One size does not fit all. J Am Soc Neprol 14: 2414-2416, 2003
8. Tredger JM, Brown NW: Mycophenolate: Better value through monitoring? Transplantation 81: 507-508, 2006
9. Van Gelder T, Le Meur Y, Shaw LM, Oellerich M, DeNofrio D, Holt C, Kaplan B, Kuypers D, Meiser B, Toenshoff B, Mamelok RD: Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit 28: 145-154, 2006
10. Nawrocki A, Korecka M, Solari S, Kang J, Shaw LM: Mycophenolic acid. In: Applied Pharmacokinetics and Pharmacodynamics: Principles of Therapeutic Drug Monitoring, 4th Ed., edited by Burton ME, Shaw LM, Schentag JJ, Evans WE, Philadelphia, Lippincott Williams & Wilkins, 2006, pp 563-594
11. Kobayashi M, Saitoh H, Tadano K, Tadano K, Takahashi Y, Hirano T: Cyclosporine A, but not tacrolimus, inhibits the biliary excretion of mycophenolic acid glucuronide possibly mediated by multidrug resistance-associated protein 2 in rats. J Pharmacol Exp Ther 309: 1029-1035, 2004
12. Shaw LM, Korecka M, Aradhye S, Grossman R, Grossman R, Bayer L, Innes C, Cucciara A, Barker C, Naji A, Nicholls A, Brayman K: Mycophenolic acid area under the curve values in African American and Caucasian renal transplant patients are comparable. J Clin Pharmacol 40: 624-633, 2000
13. Kaplan B, Gruber SA, Nallamathou R, Katz SM, Shaw LM: Decreased protein binding of mycophenolic acid associated with leucopenia in a pancreas transplant recipient with renal failure. Transplantation 65: 1127-1129, 1998
14. Kaplan B, Meier-Kriesche HU, Friedman G, Mulgaonkar S, Gruber S, Korecka M, Brayman KL, Shaw LM: The effect of renal insufficiency on mycophenolic acid protein binding. J Clin Pharmacol 39: 715-720, 1999
15. Pisupati J: Regulation of Glucuronidation of Mycophenolic Acid [doctoral thesis], Pittsburgh, University of Pittsburgh, 2001
16. Naesens M, Kuypers DR, Streit F, Armstrong VW, Oellerich M, Verbeke K, Vanrenterghem Y: Rifampin induces alterations in mycophenolic acid glucuronidation and elimination: Implications for drug exposure in renal allograft recipients. Clin Pharmacol Ther 80: 509-521, 2006
17. Naderer OJ, Dupuis RE, Whiwattanawonga K, Campbell BJ, Hege SG, Smith PC, Johnson MW: Reduction of plasma mycophenolic acid and its glucuronide concentrations with antibiotic treatment [Abstract]. Clin Pharm Ther 65: 159, 1999
18. Schmidt LE, Rasmussen A, Norrelykke MR, Poulsen HE, Hansen BA: The effect of selective bowel decontamination on the pharmacokinetics of mycophenolate mofetil in liver transplant recipients. Liver Transpl 7: 739-742, 2001
19. Van Gelder T, Klupp J, Barten MJ, Christians U, Morris RE: Comparison of the effects of tacrolimus and cyclosporine on the pharmacokinetics of mycophenolic acid. Ther Drug Monit 23: 119-128, 2001
20. Ito S, Ieiri I, Tanabe M, Suzuki A, Higuchi S, Otsubo K: Polymorphism of the ABC transporter genes, MDR1, MRP1 and MRP2/cMOAT, in healthy Japanese subjects. Pharmacogenetics 11: 175-184, 2001
21. Hesselink DA, Van Hest RM, Mathot RA, Bonthuis F, Weimar W, de Bruin RW, van Gelder T: Cyclosporine interacts with mycophenolic acid by inhibiting the multidrug resistance-associated protein 2. Am J Transplant 5: 987-994, 2005
22. Picard N, Ratanasavanh D, Premaud A, LeMeur Y, Marquet P: Identification of the UDP-glucuronosyltransferase isoforms involved in mycophenolic acid phase 2 metabolism. Drug Metab Dispos 33: 139-146, 2005
23. Kuypers DR, Naesens M, Vermeire S, Vanrenterghern Y: The impact of uridine diphosphate-glucuronosyl-transferase 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 78: 351-361, 2005
24. Levesque E, Delage R, Benoit-Biancamano MO, Caron P, Bernard O, Couture F, Guillemette C: The impact of UGT1A8, UGT1A9, and UGT2B7 genetic polymorphisms on the pharmacokinetic profile of mycophenolic acid after a single oral dose in healthy volunteers. Clin Pharmacol Ther 81: 392-400, 2007
25. Van Agteren M, Van Schaik R, De Fijter H, Naesens M, Kuypers DR, Verbeke K, Vanrenterghern Y: The impact of MRP2 gene polymorphism on mycophenolic acid exposure in renal transplant patients [Abstract]. Transplantation 82[Suppl 21: 478, 2006
26. Naesens M, Kuypers DR, Verbeke K, Vanrentergheim Y: Multidrug resistance protein 2 genetic polymorphisms influence mycophenolic acid exposure in renal allograft recipients. Transplantation 82: 1074-1084, 2006
27. Wang J, Zeevi A, Webber S, Girnita DM, Addonizio L, Selby R, Hutchinson IV, Burckart GJ: A novel variant L263F in human inosine 5′-monophosphate dehydrogenase 2 is associated with diminished enzyme activity. Pharmacogenet Genomics 17: 283-290, 2007
28. Pescovitz MD, Gaasch A, Gaston R, Rajagopalan P, Tomlanovich S, Weinstein S, Bumgardner GL, Melton L, Ducray PS, Banken L, Hall J, Boutouyrie BX: Equivalent pharmacokinetics of mycophenolate mofetil in African-American and Caucasian male and female stable renal allograft recipients. Am J Transplant 3: 1581-1586, 2003
29. Van Hest R, Mathot RA, Pescovitz MD, Gordon R, Mamelok RD, van Gelder T: 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 17: 871-880, 2006
30. Shum B, Duffull SB, Taylor PJ, Tett SE: Population pharmacokinetic analysis of mycophenolic acid in renal transplant recipients following oral administration of mycophenolate mofetil. Br J Clin Pharmacol 56: 188-197, 2003
31. Le Guellec, Bourgoin H, Buchler M, Le Meur Y, Lebranchu Y, Marquet P, Paintaud G: Population pharmacokinetics and Bayesian estimation of mycophenolic acid concentrations in stable renal transplant patients. Clin Pharmacokinet 43: 253-266, 2004
32. Van Hest R, Van Gelder T, Vulto AG, Mathot RA: Population pharmacokinetics; of mycophenolic acid in renal transplant recipients. Clin Pharmacokinet 44: 1083-1096, 2005
33. Cremers; S, Schoemaker R, Scholten E, den Hartigh J, Koenig-Quartel J, van Kan E, Leendert P, de Fijter J: Characterizing the role of enterohepatic recycling in the interactions between mycophenolate mofetil and calcineurin inhibitors in renal transplant patients by pharmacokinetic modeling. Br J Clin Pharmacol 60: 249-256, 2005
34. Payen S, Zhang D, Maisin A, Popon M, Bensman A, Bouissou F, Loirat C: Population pharmacokinetics of mycophenolic acid in kidney transplant pediatric and adolescent patients. Ther Drug Monit 27: 378-388, 2005
35. Van Hest RM, Van Gelder T, Bouw R, Goggin T, Gordon R, Mamelok RD, Mathot RA: Time-dependent clearance of mycophenolic acid in renal transplant recipients. Br J Clin Pharmacol 63: 741-752, 2007
36. Takahashi K, Ochiai T, Uchida K, Yasumura T, Ishibashi M, Suzuki S, Otsubo O, Isono K, Takagi H, Oka T: Pilot study of mycophenolate mofetil (RS-61443) in the prevention of acute rejection following renal transplantation in Japanese patients. RS-61443 Investigation Committee - Japan. Transplant Proc 27: 1421-1424, 1995
37. Van Gelder T, Hilbrands LB, Vanrenterghern Y, Weimar W, de Fijter JW, Squifflet JP, Hene RJ, Verpooten GA, Navarro MT, Hale MD, Nicholls AJ: A randomized double blind, multicenter plasma concentration study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation 68: 261-266, 1999
38. Weber LT, Shipkova M, Armstrong VW, Wagner N, Schütz E, Mehls O, Zimmerhackl LB, Oellerich M, Tonshoff B: The pharmacokinetic-pharmacodynamic relationship for total and free mycophenolic acid in pediatric renal transplant recipients: A report of the German study group on mycophenolate mofetil therapy. J Am Soc Nephrol 13: 759-768, 2002
39. Nicholls AJ: Opportunities for therapeutic monitoring of mycophenolate mofetil does in renal transplantation suggested by the pharmacokinetic/ pharmacodynamic relationship for mycophenolic acid and suppression of rejection. Clin Biochem 31: 329-333, 1998
40. Schutz E, Armstrong VW, Shipkova M, Weber L, Niedmann PD, Lammersdorf T, Wiesel M, Mandelbaum A, Zimmerhackl LB, Mehls O, Tonshoff B, Oellerich M: Limited sampling strategy for the determination of mycophenolic acid area under the curve in pediatric kidney recipients. German Study Group on MMF Therapy in Pediatric Renal Transplant Recipients. Transplant Proc 30: 1182-1184, 1998
41. Willis C, Taylor PJ, Salm P, Tett SE, Pillans PI: Evaluation of limited sampling strategies for estimation of 12-hour mycophenolic acid area under the plasma concentrationtime curve in adult renal transplant patients. Ther Drug Monit 22: 549-554, 2000
42. Filler G, Mai I: Limited sampling strategy for mycophenolic acid area under the curve. Ther Drug Monit. 13[Suppl 1]: S301-S305, 2000
43. Yeung S, Tong KI, Tsang WK, Tang HL, Fung KS, Chan HW, Chan AY, Chan L: Determination of mycophenolate area under the curve by limited sampling strategy. Trans- plant Proc 33: 1052-1053, 2001
44. Le Guellec C, Buchler M, Giranudeau B, Le Meur Y, Gakoue JE, Lebranchu Y, Marquet P, Paintaud G: Simultaneous estimation of cyclosporine and mycophenolic acid areas under the curve in stable renal transplant patients using a limited sampling strategy. Eur J Clin Pharmacol 57: 805-811, 2002
45. Pawinski T, Hale M, Korecka M, Fitzsimmons WE, Shaw LM: Limited sampling strategy for the estimation of mycophenolic acid area under the curve in adult renal transplant patients treated with concomitant tacrolimus. Clin Chem 48: 1497-1504, 2002
46. Kuypers DR, Claes K, Evenpoel P, Maes B, Coosemans W, Pirenne J, Vanrenterghem Y: Long-term changes in mycophenolic acid exposure in combination with tacrolimus and corticosteroids are dose dependent and not reflected by trough plasma concentration: A prospective study in 100 de novo renal allograft recipients. J Clin Pharmacol 43: 866-880, 2003
47. Figurski M, Nawrocki A, Pescovitz MD, Weber LT, Hoecker B, Armstrong VW, Oellerich M, Tonshoff B: Limited sampling strategy for estimation of MPA AUC in patients receiving concomitant Sirolimus [Abstract] Transplantation 82[Suppl 2]: 502-503, 2006
48. Weber L, Hoecker B, Armstrong VW: Validation of an abbreviated pharmacokinetics profile for the estimation of mycophenolic acid exposure in pediatric renal transplant recipients. Ther Drug Monit 28: 623-631, 2006
49. Oellerich M, Shipkova M, Schutz E, Wieland E, Weber L, Tonshoff B, Armstrong VW: 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 22: 20-26, 2000 [published erratum appears in Ther Drug Monit 22: 500, 2000]
50. Dorn AR, Tsai J, Mountain L, Domke I, Engelmayer J, Langmann T, Leibisch G, Luthe H, Schmitz G, Streit F, Oellerich M: Assessment of total and free mycophenolic acid in transplant patient plasma by enzyme receptor assay. [Abstract] Ther Drug Monit 27: 216-217, 2005
51. Domke I, Engelmayer J, Langmann T, et al.: Measurement of total and free mycophenolic acid with new enzyme receptor methods on COBAS INTEGRA Systems. Clin Chem 51: C148, 2005
52. Van Gelder T, Shaw LM: The rationale for and limitations of therapeutic drug monitoring for mycophenolate mofetil in transplantation. Transplantation 80: S244-S253, 2005
53. Shaw LM, Korecka M, Venkataramanan R, Goldberg L, Bloom R, Brayman KL: Mycophenolic acid pharmacodynamics and pharmacokinetics provide a basis for rational monitoring strategies. Am J Transplant 3: 534-542, 2003
54. Glander P, Hambach P, Braun KP, Fritsche L, Waiser J, Mai I, Neumayer HH, Budde K: Effect of mycophenolate mofetil on IMP dehydrogenase after the first dose and after long-term treatment in renal transplant recipients. Int J Clin Pharmacol Ther 41: 470-476, 2003
55. Budde K, Glander P, Brauer S, Braun K, Waiser J, Fritsche L, Mai I, Roots I, Neumayer HH: Pharmacodynamic monitoring of mycophenolate mofetil. Clin Chem Lab Med 38: 1213-1216, 2000
56. Glander P, Hambach P, Braun KP, Fritsche L, Giessing M, Mai I, Einecke G, Waiser J, Neumayer HH, Budde K: Pre-transplant inosine monophosphate dehydrogenase activity is associated with clinical outcome after renal transplantation. Am J Transplant 4: 2045-2051, 2004
57. Bullingham RE, Nicholls AJ, Kamm BR: Clinical pharmacokinetics of mycophenolate mofetil. Clin Pharmacokinet 34: 429-455, 1998
58. Hale MD, Nicholls AJ, Bullingham RE, Hene R, Hoitsma A, Squifflet JP, Weimar W, Vanrenterghem Y, Van de Woude FJ, Verpooten GA: The pharmacokinetic-pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 64: 672-683, 1998
59. LeMeur Y, Buchler M, Lavaud S, Etienne I, Westeel P-F, Thierry A, Caillard S, Villemain F, Allard C, Rostaing L, Thervet E, Szelag J-C, Rerolle P, Touchard G, Marquet P: Therapeutic drug monitoring of MMF: A randomized multicenter study concentration controlled vs. fixed dose in kidney transplant recipients. Presented at the 2006 World Transplant Congress, Boston MA, 2006 [Abstract]. Transplantation 82[Suppl 2]: 343-344, 2006
60. Van Gelder T, Silva HT, De Fijter H, Budde K, Kuypers D, Tyden G, Lohmus A: A prospective, randomised study comparing fixed dose versus concentration controlled MMF regimes for de novo patients following renal transplantation (the FDCC trial) [Abstract]. Transplantation 82[Suppl 21: 343, 2006
61. Bloom R, Naraghi R, Cibrik DM, Angelis M, Mulgoankar S, Kaplan B, Gaston R, Gordon R: Opticept trial: Interim results of 6-month efficacy and safety of monitored mycophenolate mofetil (MMF) in combination with CNI in renal transplantation [Abstract]. Transplantation 82[Suppl 2]: 344, 2006
62. Halloran PF: Immunosuppressive drugs for kidney transplantation. N Engl J Med 351: 2715-2729, 2004
63. Pillans PI, Rigby RJ, Kubler P, Willis C, Salm P, Tett SE, Taylor PJ: A retrospective analysis of mycophenolic acid and cyclosporine concentrations with acute rejection in renal transplant recipients. Clin Biochem 34: 77-81, 2001
64. Kiberd BA, Lawen J, Fraser AD, Keough-Ryan T, Belitsky P: Early adequate mycophenolic acid exposure is associated with less rejection in kidney transplantation. Am J Transplant 4: 1079-1083, 2004
65. Cattaneo D, Gaspari F, Ferrari S, Stucchi N, Del Priore L, Perico N, Gotti E, Remuzzi G: Pharmacokinetics help optimizing mycophenolate mofetil dosing in kidney transplant patients. Clin Transplant 15: 402-409, 2001
66. Atcheson BA, Taylor PJ, Mudge DW, Johnson DW, Hawley CM, Campbell SB, Isbel NM, Pillans PI, Tett SE: Mycophenolic acid pharmacokinetics and related outcomes early after renal transplant. Br J Clin Pharmacol 59: 271-280, 2005
67. Kuypers DR, Claes K, Evenepoel P, Maes B, Vanrenterghem Y: Clinical efficacy and toxicity profile of tacrolimus and mycophenolic acid in relation to combined long-term pharmacokinetics in de novo renal allograft recipients. Clin Pharmacol Ther 75: 434-447, 2004
68. Borrows R, Chusney G, Loucaidou M, James A, Lee J, Tromp JV, Owen J, Cairns T, Griffith M, Hakim N, McLean A, Palmer A, Papalois V, Taube D: Mycophenolic acid 12-h trough level monitoring in renal transplantation: Association with acute rejection and toxicity. Am J Transplant 6: 121-128, 2006
69. Mourad M, Malaise J, Chaib Eddour D, De Meyer M, Konig J, Schepers R, Squifflet JP, Wallemacq P: Correlation of mycophenolic acid pharmacokinetic parameters with side effects in kidney transplant patients treated with mycophenolate mofetil. Clin Chem 47: 88-94, 2001