Influence of interactions between immunosuppressive drugs on therapeutic drug monitoring

Annals of Transplantation

Volumn 13, Issue 3, 2008, Pages 11-18

  Kuypers, Dirk R ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

Corticosteroids; Cyclosporine A; Drug interactions; Everolimus; Mycophenolate mofetil; Mycophenolic acid; Sirolimus; Tacrolimus; Therapeutic drug monitoring

Indexed keywords

ANTIMITOTIC AGENT; AZATHIOPRINE; CORTICOSTEROID; CYCLOSPORIN A; CYTOCHROME P450 3A5; DRUG METABOLITE; EVEROLIMUS; GLUCURONOSYLTRANSFERASE; GLUCURONOSYLTRANSFERASE 1A9; IMMUNOSUPPRESSIVE AGENT; MULTIDRUG RESISTANCE PROTEIN 2; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISOLONE; RAPAMYCIN; TACROLIMUS; CYCLOSPORIN; DRUG DERIVATIVE;

AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG MONITORING; DRUG POTENTIATION; ENTEROHEPATIC CIRCULATION; GRAFT DYSFUNCTION; GRAFT RECIPIENT; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MAINTENANCE THERAPY; NEPHROTOXICITY; SINGLE NUCLEOTIDE POLYMORPHISM; CELL PROLIFERATION; DRUG EFFECT; REVIEW;

CELL PROLIFERATION; CYCLOSPORINE; DRUG MONITORING; HUMANS; IMMUNOSUPPRESSIVE AGENTS; SIROLIMUS; TACROLIMUS;

EID: 58749088941     PISSN: 14259524     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (50)

1. Bullingham R, Nicholls AJ, Kamm BR: Clinical pharmacokinetics of mycophenolate mofetil. Clin Pharmacokinet, 1998; 64: 429-55
2. Shipkova M, Armstrong VW, Wieland E et al: Identification of glucoside and carboxyl-linked glucuronide conjugates of mycophenolic acid in plasma of transplant recipients treated with mycophenolate mofetil. Br J Pharmacol, 1999; 126(5): 1075-82
3. Shipkova M, Strassburg CP, Braun F et al: Glucuronide and glucoside conjugation of mycophenolic acid by human liver, kidney and intestinal microsomes. Br J Pharmacol, 2001; 132: 1027-34
4. Kobayashi M, Saitoh H, Kobayashi M et al: Cyclosporin A, but not tacrolimus, inhibits the biliary excretion of mycophenolic acid glucuronide possibly mediated by multidrug resistanceassociated protein 2 in rats. J Pharmacol Exper Ther, 2004; 309: 1029-35
5. Shipkova M, Armstrong VW, Kuypers D et al: Effect of cyclosporine withdrawal on mycophenolic acid pharmacokinetics in kidney transplant recipients with deteriorating renal function: preliminary report. Ther Drug Monit, 2001; 23(6): 717-21
6. Kuypers DRJ, Claes K, Evenepoel P et al: Longterm 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, 2003; 43(8): 866-80
7. Naesens M, de Loor H, Vanrenterghem Y, Kuypers DR: The Impact of Renal Allograft Function on Exposure and Elimination of Mycophenolic Acid (MPA) and Its Metabolite MPA 7-O-glucuronide. Transplantation, 2007; 84(3): 362-73
8. Atcheson B, Taylor P, Kirkpatrick C et al: Free mycophenolic acid should be monitored in renal transplant recipients with hypoalbuminemia. Ther Drug Monit, 2004; 26(3): 284-86
9. Kuypers DRJ, Naesens M, Vermeire S et al: The impact of uridine diphosphate-glucuronosyltransferase 1A9 (UGT1A9) gene promoter region singlenucleotide polymorphisms T-275A and C-2152T on early mycophenolic acid dose-interval exposure in de novo renal allograft recipients. Clin Pharmacol Ther, 2005; 78: 351-61
10. Naesens M, Kuypers DR, Verbeke K, Vanrenterghem Y: Multidrug Resistance Protein 2 Genetic Polymorphisms Influence Mycophenolic Acid Exposure in Renal Allograft Recipients. Transplantation, 2006; 82(8): 1074-84
11. Zucker K, Rosen A, Tsaroucha A et al: Unexpected augmentation of mycophenolic acid pharmacokinetics in renal transplant patients receiving tacrolimus and mycophenolate mofetil in combination therapy, and analogous in vitro findings. Transplant Immunol, 1997; 5(3): 225-32
12. van Gelder T, Klupp J, Barten MJ et al: Comparison of the effects of tacrolimus and cyclosporine on the pharmacokinetics of mycophenolic acid. Ther Drug Monit, 2001; 23(2): 119-28
13. Hesselink DA, van Hest RM, Mathot RAA et al: Cyclosporine interacts with mycophenolic acid by inhibiting the multidrug resistance-associated protein 2. Am Journal Transplant, 2005; 5(5): 987-95
14. Westley IS, Brogan LR, Morris RG et al: Role of Mrp2 in the hepatic disposition of mycophenolic acid: effect of cyclosporin. Drug Metab Dispos, 2006; 34(2): 261-266
15. Bruce Kaplan, Herwig-Ulf Meier-Kriesche, Paula Minnick, Marie-Claude Bastien, Romain Sechaud, Ching-Ming Yeh, Sebastien Balez, Franck Picard, Robert Schmouder: Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of co-administered enteric-coated mycophenolate sodium. Clin Transplant, 2005; 19(4): 551-558
16. DRJ Kuypers, H Ekberg, J Grinyo et al: Pharmacokinetics of mycophenolate mofetil at 12 months in the presence and absence of cyclosporine. Transplant Int, 2005; 18(Suppl.1): 50 (Abstract)
17. van Gelder T, Le Meur Y, Shaw LM et al: Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit, 2006; 28: 145-54
18. van Gelder T, Tedesco-Silva H, de Fijter H et al: for the FDCC Study Group: A prospective, randomized study comparing fi xed dose versus concentration controlled MMF regimens for de novo patients following renal transplantation (The FDCC trial). Am J Transplant, 2006; 6(Suppl.2): 343 (Abstract)
19. Grinyo J, Ekberg H, Oppenheimer F et al: Pharmacokinetics of total and free mycophenolic acid (MPA) when mycophenolate mofetil (MMF) is administered with low-dose tacrolimus, low-dose cyclosporine, low-dose sirolimus or standard-dose cyclosporine in renal transplantation. Results of the Symphony PK substudy. Am J Transplant, 2006; 6(Suppl.2): 345 (Abstract)
20. Le Meur Y, Büchler M, Thierry A et al: Individualized mycophenolate mofetil dosing based on drug exposure signifi cantly improves patient outcomes after renal transplantation. Am J Transplant, 2007; 7: 2496-503
21. Zucker K, Tsaroucha A, Olson L et al: Evidence that tacrolimus augments the bioavailability of mycophenolate mofetil through the inhibition of mycophenolic acid glucuronidation. Ther Drug Monit, 1999; 21: 35-43
22. Cattaneo D, Merlini S, Zenoni S et al: Influence of Co-Medication with Sirolimus or Cyclosporine on Mycophenolic Acid Pharmacokinetics in Kidney Transplantation. Am J Transplant, 2005; 5(12): 2937-44
23. Pescovitz MD, Vincenti F, Hart M et al: Pharmacokinetics, safety, and efficacy of mycophenolate mofetil in combination with sirolimus or ciclosporin in renal transplant patients. Br J Clin Pharmacol, 2007; 64(6): 758-71
24. Renders L, Steinbach R, Valerius T et al: Low-dose sirolimus in combination with mycophenolate mofetil improves kidney graft function late after renal transplantation and suggests pharmacokinetic interaction of both immunosuppressive drugs. Kidney Blood Press Res, 2004; 27(3): 181-85
25. Cattaneo D, Perico N, Gaspari F et al: Glucocorticoids interfere with mycophenolate mofetil bioavailability in kidney transplantation. Kidney Int, 2002; 62(3): 1060-67
26. Stepkowski SM, Napoli KL, Wang ME et al: Effects of the pharmacokinetic interaction between orally administered sirolimus and cyclosporine on the synergistic prolongation of heart allograft survival in rats. Transplantation, 1996; 62(7): 986-94
27. Podder H, Stepkowski SM, Napoli KL et al: Pharmacokinetic interactions augment toxicities of sirolimus/cyclosporine combinations. J Am Soc Nephrol, 2001; 12: 1059-71
28. Napoli KL, Wang ME, Stepkowski SM et al: Relative tissue distributions of cyclosporin and sirolimus after concomitant peroral administration in the rat: evidence for pharmacokinetic interactions. Ther Drug Monit, 1998; 20(2): 123-33
29. Kahan BD The Rapamune US Study Group: Efficacy of sirolimus compare with azathioprine for reduction of acute renal allograft rejection: a randomised multicentre study. Lancet, 2000; 356: 194-202
30. MacDonald AS The RAPAMUNE Global Study Group: A worldwide, phase III, randomised, controlled, safety and effi cacy study of a sirolimus/cyclosporine regimen for prevention of acute rejection in recipients of primary mismatched renal allografts. Transplantation, 2001; 71(2): 271-80
31. Nashan B, Curtis J, Ponticelli C et al: 156 Study Group: Everolimus and reduced-exposure cyclosporine in de novo renal-transplant recipients: a three-year phase II, randomized, multicenter, openlabel study. Transplantation, 2004; 78(9): 1332-40
32. Wiseman AC, Kam I, Christians U et al: Fixed-dose sirolimus with reduced dose calcineurin inhibitor: the university of Colorado experience. Transplant Proc, 2003; 35(Suppl.3A): 122S-24S
33. Hong JC, Kahan BD: Use of anti-CD25 monoclonal antibody in combination with rapamycin to eliminate cyclosporine treatment during the induction phase of immunosuppression. Transplantation, 1999; 68(5): 701-4
34. Langer RM, Hong DM, Katz SM et al: Basiliximabsirolimus-prednisone induction regimen followed by delayed low-dose cyclosporine in renal transplant recipients of living donors. Transplant Proc, 2002; 34: 3162-64
35. Johnson RW, Kreis H, Oberbauer R et al: Sirolimus allows early cyclosporine withdrawal in renal transplantation resulting in improved renal function and lower blood pressure. Transplantation, 2001; 72(5): 777-86
36. Lorber M, Mulgaonkar S, Butt KMH et al: the B251 Study Group: Everolimus versus Mycophenolate Mofetil in the Prevention of Rejection in De Novo Renal Transplant Recipients: A 3-Year Randomized, Multicenter, Phase III Study. Transplantation, 2005; 80(2): 244-52
37. Vítko Š, Margreiter R, Weimar W et al: for the RAD B201 Study Group: Three-Year Efficacy and Safety Results from a Study of Everolimus Versus Mycophenolate Mofetil in de novo Renal Transplant Patients. Am J Transplant, 2005; 5(10): 2521-30
38. Konishi H, Sumi M, Shibata N et al: Decrease in oral bioavailability of ciclosporin by intravenous pulse of methylprednisolone succinate in rats. J Pharmacy Pharmacol, 2004; 56: 1259-66
39. Jin M, Shimada T, Yokogawa K et al: Site-dependent contributions of P-glycoprotein and CYP3A to cyclosporine A absorption, and effect of dexamethasone in small intestine of mice. Biochem Pharmacol, 2006; 72(8): 1042-50
40. van Duijnhoven EM et al: Increase in tacrolimus trough levels after steroid withdrawal. Transplant Int, 2003; 16: 721-25
41. Hesselink DA, Ngyuen H, Wabbijn M et al: Tacrolimus dose requirement in renal transplant recipients is signifi cantly higher when used in combination with corticosteroids. Br J Clin Pharmacol, 2003; 56(3): 327-30
42. Shimada T et al: Lowered blood concentration of tacrolimus and its recovery with changes in expression of CYP3A and P-glycoprotein after highdose steroid therapy. Transplantation, 2002; 74: 1419-24
43. Roberts P, Rollins K, Kashuba A et al: The influence of CYP3A5 genotype on dexamethasone induction of CYP3A activity in African Americans. Drug Metab Dispos, 2008; Epub ahead of print
44. McAlister VC, Mahalati K, Peltekian KM et al: A clinical pharmacokinetic study of tacrolimus and sirolimus combination immunosuppression comparing simultaneous to separated administration. Ther Drug Monit, 2002; 24: 346-50
45. Kuypers DRJ, Claes K, Evenepoel P et al: Longterm pharmacokinetic study of the novel combination of tacrolimus and sirolimus in de novo renal allograft recipients. Ther Drug Monit, 2003; 25(4): 447-51
46. Undre NA: Pharmacokinetics of tacrolimus-based combination therapies. Nephrol Dial Transplant, 2003; 18(Suppl.1): 12-15
47. Brandhorst G, Tenderich G, Zittermann A et al: Everolimus exposure in cardiac transplant recipients is infl uenced by concomitant alcineurin inhibitor. Ther Drug Monit, 2008; 30(1): 113-16
48. Ciancio G, Burke GW, Gaynor JJ et al: A randomized long-term trial of tacrolimus and sirolimus versus tacrolimus and mycophenolate mofetil versus cyclosporine (Neoral) and sirolimus in renal transplantation. I. Drug interactions and rejection at one year. Transplantation, 2004; 77(2): 244-51
49. Wu F, Tsai M, Chen R et al: Effects of calcineurininhibitors on sirolimus pharmacokinetics during staggered administration in renal transplant recipients. Pharmacotherapy, 2005; 25(5): 646-53
50. Jusko W, Ferron G, Mis S et al: Pharmacokinetics of prednisolone during administration of sirolimus in patients with renal transplants. J Clin Pharmacol, 1996; 36(12): 1100-1106