Evaluation of mycophenolic acid exposure using a limited sampling strategy in renal transplant recipients

American Journal of Nephrology

Volumn 37, Issue 6, 2013, Pages 534-540

  Li, Jun ^a   Liu, Yanfeng ^c   Huang, Jiawen ^c   Fu, Qian ^a   Chen, E ^a   Liu, Longshan ^a   Zhang, Rui ^b   Huang, Min ^a   Wang, Changxi ^a  

^a SUN YAT SEN UNIVERSITY   (China)

^b The Second Affiliated Hospital   (China)

^c JINAN UNIVERSITY   (China)

Author keywords

Limited sampling strategy; Mycophenolate sodium; Mycophenolic acid; Renal transplantation

Indexed keywords

CREATININE; CYCLOSPORIN; METHYLPREDNISOLONE; MYCOPHENOLIC ACID; PREDNISONE; RAPAMYCIN; STEROID; TACROLIMUS; THYMOCYTE ANTIBODY; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER;

ADULT; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CLINICAL ARTICLE; CREATININE BLOOD LEVEL; DIARRHEA; DRUG BLOOD LEVEL; DRUG EXPOSURE; FEMALE; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; HUMAN; KIDNEY ALLOGRAFT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; LEUKOPENIA; MALE; PREDICTIVE VALIDITY; PRIORITY JOURNAL; VIRUS INFECTION; CHINESE; MAXIMUM PLASMA CONCENTRATION; SAMPLING;

ADULT; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOSUPPRESSION; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; TABLETS, ENTERIC-COATED; TACROLIMUS; TIME FACTORS;

EID: 84877850812     PISSN: 02508095     EISSN: 14219670     Source Type: Journal    
DOI: 10.1159/000351180     Document Type: Article

References (42)

1. Hughes SE, Gruber SA: New immunosup-pressive drugs in organ transplantation. J Clin Pharmacol 1996; 36:1081-1092. (Pubitemid 27056934)
2. Scott LJ, McKeage K, Keam SJ, Plosker GL: Tacrolimus: a further update of its use in the management of organ transplantation. Drugs 2003; 63:1247-1297. (Pubitemid 36750952)
3. Roth D, Colona J, Burke GW, Ciancio G, Es-quenazi V and Miller J: Primary immunosup-pression with tacrolimus and mycophenolate mofetil for renal allograft recipients. Trans-plantation 1998; 65:248-252. (Pubitemid 28099219)
4. Squifflet JP, Backman L, Claesson K, et al: Dose optimization of mycophenolate mofetil when administered with a low dose of tacro-limus in cadaveric renal transplant recipients. Transplantation 2001; 72:63-69. (Pubitemid 32652507)
5. Tett SE, Saint-Marcoux F, Staatz CE, et al: My-cophenolate, clinical pharmacokinetics, for-mulations, and methods for assessing drug ex-posure. Transplant Rev (Orlando) 2011; 25: 47-57.
6. Mathew BS, Fleming DH, Annapandian VM, Prasanna S, Prasanna CG, Chandy SJ, John GT: A reliable limited sampling strategy for the estimation of mycophenolic acid area un-der the concentration-time curve in adult re-nal transplant patients in the stable posttrans-plant period. Ther Drug Monit 2010; 32:136-140.
7. Figurski MJ, Nawrocki A, Pescovitz MD, Bouw R, Shaw LM: Development of a predic-tive limited sampling strategy for estimation of mycophenolic acid area under the concen-tration-time curve in patients receiving con-comitant sirolimus or cyclosporine. Ther Drug Monit 2008; 30:445-455.
8. Miura M, Satoh S, Niioka T, Kagaya H, Saito M, Hayakari M, Habuchi T, Suzuki T: Early phase limited sampling strategy characteriz-ing tacrolimus and mycophenolic acid phar-macokinetics adapted to the maintenance phase of renal transplant patients. Ther Drug Monit 2009; 31:467-474.
9. Teshima D, Maiguma T, Kaji H, Otsubo K, Kitagawa N, Okabe Y, Sugitani A, Tanaka M, Oishi R: Estimation of the area under the curve for mycophenolic acid in adult renal transplant patients with concomitant tacroli-mus using a limited sampling strategy. J Clin Pharm Ther 2008; 33:159-163. (Pubitemid 351341407)
10. Miura M, Satoh S, Niioka T, Kagaya H, Saito M, Hayakari M, Habuchi T, Suzuki T: Limited sampling strategy for simultaneous estima-tion 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)
11. Pawinski T, Hale M, Korecka M, Fitzsim-mons WE, Shaw LM: Limited sampling strat-egy 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)
12. Budde K, Bauer S, Hambach P, Hahn U, Rö-blitz H, Mai I, Diekmann F, Neumayer HH, Glander P: Pharmacokinetic and pharmaco-dynamic comparison of enteric-coated myco-phenolate sodium and mycophenolate mofetil in maintenance renal transplant patients. Am J Transplant 2007; 7:888-898. (Pubitemid 46481185)
13. Teshima D, Otsubo K, Kitagawa N, Yoshimu-ra S, Itoh Y, Oishi R: High-performance liquid chromatographic method for mycophenolic acid and its glucuronide in serum and urine. J Clin Pharm Ther 2003; 28:17-22. (Pubitemid 36313171)
14. Sheiner LB, Beal SL: Some suggestions for measuring predictive performance. J Phar-macokinet Biopharm 1981; 9:503-512.
15. Wong KM, Shek CC, Chau KF, Li CS: Abbre-viated tacrolimus area-under-the-curve mon-itoring for renal transplant recipients. Am J Kidney Dis 2000; 35:660-666.
16. Poge U, Gerhardt T, Palmedo H, Klehr HU, Sauerbruch T, Woitas RP: MDRD equations for estimation of GFR in renal transplant recipients. Am J Transplant 2005; 5: 1306-1311. (Pubitemid 40839418)
17. Shaw LM, Korecka M, Venkataramanan R, Goldberg L, Bloom R, Brayman KL: Myco-phenolic acid pharmacodynamics and phar-macokinetics provide a basis for rational monitoring strategies. Am J Transplant 2003; 3:534-542. (Pubitemid 36612836)
18. Shaw LM, Pawinski T, Korecka M, Nawrocki A: Monitoring of mycophenolic acid in clini-cal transplantation. Ther Drug Monit 2002; 24:68-73. (Pubitemid 34106734)
19. Shaw LM, Holt DW, Oellerich M, Meiser B, van Gelder T: Current issues in therapeutic drug monitoring of mycophenolic acid: re-port of a roundtable discussion. Ther Drug Monit 2001; 23:305-315. (Pubitemid 32708913)
20. Staatz CE, Tett SE: Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Phar-macokinet 2007; 46:13-58. (Pubitemid 46091591)
21. Shaw LM, Korecka M, DeNofrio D, Brayman KL: Pharmacokinetic, pharmacodynamic, and outcome investigations as the basis for myco-phenolic acid therapeutic drug monitoring in renal and heart transplant patients. Clin Bio-chem 2001; 34: 17-22. (Pubitemid 32178501)
22. Weber LT, Shipkova M, Armstrong VW, Wagner N, Schütz E, Mehls O, Zimmerhackl LB, Oellerich M, Tönshoff B: Comparison of the EMIT immunoassay with HPLC for thera-peutic drug monitoring of mycophenolic acid in pediatric renal-transplant recipients on my-cophenolate mofetil therapy. Clin Chem 2002; 48:517-525. (Pubitemid 34174582)
23. Arns W, Cibrik DM, Walker RG, Mourad G, Budde K, Mueller EA, Vincenti F: Therapeu-tic drug monitoring of mycophenolic acid in solid organ transplant patients treated with mycophenolate mofetil: review of the litera-ture. Transplantation 2006; 82: 1004-1012. (Pubitemid 44632114)
24. Van Gelder T, Le Meur Y, Shaw LM, et al: Therapeutic drug monitoring of mycopheno-late mofetil in transplantation. Ther Drug Monit 2006; 28:145-154. (Pubitemid 44314941)
25. Sabbatini M, Capone D, Gallo R, Pisani A, Polichetti G, Tarantino G, Gentile A, Rotaia E, Federico S: EC-MPS permits lower gas-trointestinal symptom burden despite higher MPA exposure in patients with se-vere MMF-related gastrointestinal side ef-fects. Fundam Clin Pharmacol 2009; 23: 617-624.
26. Budde K, Curtis J, Knoll G, Chan L, Neumay-er HH, Seifu Y, Hall M, ERLB302 Study Group: Enteric-coated mycophenolate sodi-um can be safely administered in mainte-nance renal transplant patients: results of a 1-year study. Am J Transplant 2004; 4:237-243. (Pubitemid 38248527)
27. De Winter BC, van Gelder T, Glander P, et al: Population pharmacokinetics of myco-phenolic acid: a comparison between enter-ic-coated mycophenolate sodium and my-cophenolate mofetil in renal transplant re-cipients. Clin Pharmacokinet 2008; 47: 827-838.
28. Cattaneo D, Cortinovis M, Baldelli S, Bitto A, Gotti E, Remuzzi G, Perico N: Pharmacoki-netics of mycophenolate sodium and compar-ison with the mofetil formulation in stable kidney transplant recipients. Clin J Am Soc Nephrol 2007; 2:1147-1155.
29. Capone D, Tarantino G, Kadilli I, Polichetti G, Basile V, Federico S, Sabbatini M: Evalua-tion of mycophenolic acid systemic exposure by limited sampling strategy in kidney trans-plant recipients receiving enteric-coated my-cophenolate sodium (EC-MPS) and cyclo-sporine. Nephrol Dial Transplant 2011; 26: 3019-3025.
30. Sommerer C, Muller-Krebs S, Schaier M, Glander P, Budde K, Schwenger V Mikus G, Zeier M: Pharmacokinetic and pharmaco-dynamic analysis of enteric-coated myco-phenolate sodium: limited sampling strate-gies and clinical outcome in renal trans-plant patients. Br J Clin Pharmacol 2010; 69: 346-357.
31. Fleming DH, Mathew BS, Prasanna S, Anna-pandian VM, John GT: A possible simplifica-tion for the estimation of area under the curve of enteric-coated mycophenolate so-dium in renal transplant patients receiving tacrolimus. Ther Drug Monit 2011; 33:165-170.
32. De Winter BC, van Gelder T, Mathot RA, Glander P, Tedesco-Silva H, Hilbrands L, Budde K, van Hest RM: Limited sampling strategies drawn within 3 hours post-dose poorly predict mycophenolic acid area-un-der-the-curve after enteric-coated mycophe-nolate sodium. Ther Drug Monit 2009; 31: 585-591.
33. Cattaneo D, Merlini S, Zenoni S, Baldelli S, Gotti E, Remuzzi G, Perico N: Influence of co-medication with sirolimus or cyclosporine on mycophenolic acid pharmacokinetics in kid-ney transplantation. Am J Transplant 2005; 5: 2937-2944. (Pubitemid 43923955)
34. Gregoor PJ, de Sevaux RG, Hene RJ, Hesse CJ, Hilbrands LB, Vos P, van Gelder T, Hoitsma AJ, Weimar W: Effect of cyclosporine on my-cophenolic acid trough levels in kidney tran-splant recipients. Transplantation 1999; 68: 1603-1606.
35. Filler G, Zimmering M, Mai I: Pharmacoki-netics of mycophenolate mofetil are influ-enced by concomitant immunosuppression. Pediatr Nephrol 2000; 14:100-104. (Pubitemid 30085288)
36. Hesselink DA, van Hest RM, Mathot RA, Bonthuis F, Weimar W, de Bruin RW, van Gelder T: Cyclosporine interacts with myco-phenolic acid by inhibiting the multidrug re-sistance-associated protein 2. Am J Trans-plant 2005; 5:987-994. (Pubitemid 40571246)
37. Staatz CE, Duffull SB, Kiberd B, Fraser AD, Tett SE: Population pharmacokinetics of my-cophenolic acid during the first week after re-nal transplantation. Eur J Clin Pharmacol 2005; 61:507.
38. Bullingham RE, Nicholls AJ, Kamm BR: Clini-cal pharmacokinetics of mycophenolate mo-fetil. Clin Pharmacokinet 1998; 34: 429-455.
39. Kuypers DR, Vanrenterghem Y, Squifflet JP, Mourad M, Abramowicz D, Oellerich M, Armstrong V, Shipkova M, Daems J: Twelve-month evaluation of the clinical pharmacoki-netics of total and free mycophenolic acid and its glucuronide metabolites in renal allograft recipients on low dose tacrolimus in combi-nation with mycophenolate mofetil. Ther Drug Monit 2003; 25:609-622. (Pubitemid 37238896)
40. Hale MD, Nicholls AJ, Bullingham RE, et al: The pharmacokinetic- pharmacodynamic re-lationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 1998; 64:672-683. (Pubitemid 29011387)
41. Naesens M, de Loor H, Vanrenterghem Y, and Kuypers DR: The impact of renal allograft function on exposure and elimination of my-cophenolic acid (MPA) and its metabolite MPA 7-O-glucuronide. Transplantation 2007; 84: 362-373. (Pubitemid 47258325)
42. Johnson HJ, Swan SK, Heim-Duthoy KL, Nicholls AJ, Tsina I, Tarnowski T: The phar-macokinetics of a single oral dose of myco-phenolate mofetil in patients with varying de-grees of renal function. Clin Pharmacol Ther 1998; 63:512-518. (Pubitemid 28277272)