Standard dosing of tacrolimus leads to overexposure in pediatric renal transplantation recipients

Pediatric Transplantation

Volumn 12, Issue 3, 2008, Pages 329-335

  Kausman, Joshua Y ^b   Patel, Bhumik ^b   Marks, Stephen D ^a,b  

^a Great Ormond Street Hospital for Children NHS Trust ^*  (United Kingdom)

^b GREAT ORMOND STREET HOSPITAL   (United Kingdom)

Author keywords

Adolescent; Child; Immunosuppression; Kidney; Tacrolimus; Transplant

Indexed keywords

AZATHIOPRINE; CYCLOSPORIN A; METHYLPREDNISOLONE; PREDNISOLONE; TACROLIMUS;

ACUTE GRAFT REJECTION; ADOLESCENT; ARTICLE; BODY HEIGHT; BODY SIZE; BODY WEIGHT; CHILD; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EXPOSURE; ETHNICITY; FEMALE; GRAFT FAILURE; GRAFT RECIPIENT; GRAFT SURVIVAL; HIGH RISK POPULATION; HUMAN; KIDNEY FAILURE; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; TREATMENT RESPONSE;

ADMINISTRATION, ORAL; ADOLESCENT; AREA UNDER CURVE; BODY SIZE; CHILD; CHILD, PRESCHOOL; FEMALE; GRAFT SURVIVAL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INFANT; KIDNEY FAILURE; KIDNEY TRANSPLANTATION; MALE; TACROLIMUS;

EID: 42549152343     PISSN: 13973142     EISSN: 13993046     Source Type: Journal    
DOI: 10.1111/j.1399-3046.2007.00821.x     Document Type: Article

References (34)

1. 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.
2. Webster AC, Woodroffe RC, Taylor RS, Chapman JR, Craig JC. Tacrolimus versus ciclosporin as primary immunosuppression for kidney transplant recipients: Meta-analysis and meta-regression of randomised trial data. BMJ 2005 : 331 : 810.
3. Undre NA, Stevenson P, Schafer A. Pharmacokinetics of tacrolimus: Clinically relevant aspects. Transplant Proc 1999 : 31 : 21S 24S.
4. Christians U, Jacobsen W, Benet LZ, Lampen A. Mechanisms of clinically relevant drug interactions associated with tacrolimus. Clin Pharmacokinet 2002 : 41 : 813 851.
5. Krishna DR, Shekar MS. Cytochrome P450 3A: Genetic polymorphisms and inter-ethnic differences. Methods Find Exp Clin Pharmacol 2005 : 27 : 559 567.
6. Eng HS, Mohamed Z, Calne R, et al. The influence of CYP3A gene polymorphisms on cyclosporine dose requirement in renal allograft recipients. Kidney Int 2006 : 69 : 1858 1864.
7. Macphee IA, Fredericks S, Tai T, et al. The influence of pharmacogenetics on the time to achieve target tacrolimus concentrations after kidney transplantation. Am J Transplant 2004 : 4 : 914 919.
8. Bekersky I, Dressler D, Mekki Q. Effect of time of meal consumption on bioavailability of a single oral 5 mg tacrolimus dose. J Clin Pharmacol 2001 : 41 : 289 297.
9. Bekersky I, Dressler D, Mekki QA. Effect of low- and high-fat meals on tacrolimus absorption following 5 mg single oral doses to healthy human subjects. J Clin Pharmacol 2001 : 41 : 176 182.
10. Kuypers DRJ, Claes K, Evenepoel P, et al. Time-related clinical determinants of long-term tacrolimus pharmacokinetics in combination therapy with mycophenolic acid and corticosteroids: A prospective study in one hundred de novo renal transplant recipients. Clin Pharmacokinet 2004 : 43 : 741 762.
11. Anglicheau D, Flamant M, Schlageter MH, et al. Pharmacokinetic interaction between corticosteroids and tacrolimus after renal transplantation. Nephrol Dial Transplant 2003 : 18 : 2409 2414.
12. Van Duijnhoven EM, Boots JM, Christiaans MH, Stolk LM, Undre NA, Van Hooff JP. Increase in tacrolimus trough levels after steroid withdrawal. Transpl Int 2003 : 16 : 721 725.
13. Bekersky I, Dressler D, Alak A, Boswell GW, Mekki QA. Comparative tacrolimus pharmacokinetics: Normal versus mildly hepatically impaired subjects. J Clin Pharmacol 2001 : 41 : 628 635.
14. Karaalp A, Demir D, Goren MZ, et al. Therapeutic drug monitoring of immunosuppressant drugs in Marmara University Hospital. Ther Drug Monit 2004 : 26 : 263 266.
15. Ku YM, Min DI. An abbreviated area-under-the-curve monitoring for tacrolimus in patients with liver transplants. Ther Drug Monit 1998 : 20 : 219 223.
16. Regazzi MB, Rinaldi M, Molinaro M, et al. Clinical pharmacokinetics of tacrolimus in heart transplant recipients. Ther Drug Monit 1999 : 21 : 2 7.
17. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med 2003 : 349 : 1157 1167.
18. Del Mar Fernandez De Gatta M, Santos-Buelga D, Dominguez-Gil A, Garcia MJ. Immunosuppressive therapy for paediatric transplant patients: Pharmacokinetic considerations. Clin Pharmacokinet 2002 : 41 : 115 135.
19. Shishido S, Asanuma H, Tajima E, Honda M, Nakai H. Pharmacokinetics of tacrolimus in pediatric renal transplant recipients. Transplant Proc 2001 : 33 : 1066 1068.
20. Racusen LC, Solez K, Colvin RB, et al. The Banff 97 working classification of renal allograft pathology. Kidney Int 1999 : 55 : 713 723.
21. Schwartz GJ, Haycock GB, Edelmann CM Jr., Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976 : 58 : 259 263.
22. Gonzalez Celedon C, Bitsori M, Tullus K. Progression of chronic renal failure in children with dysplastic kidneys. Pediatr Nephrol 2007 : 22 : 1014 1020.
23. Grenda R, Watson A, Vondrak K, et al. A prospective, randomized, multicenter trial of tacrolimus-based therapy with or without basiliximab in pediatric renal transplantation. Am J Transplant 2006 : 6 : 1666 1672.
24. Cosio FG, Amer H, Grande JP, Larson TS, Stegall MD, Griffin MD. Comparison of low versus high tacrolimus levels in kidney transplantation: Assessment of efficacy by protocol biopsies. Transplantation 2007 : 83 : 411 416.
25. Montini G, Ujka F, Varagnolo C, et al. The pharmacokinetics and immunosuppressive response of tacrolimus in paediatric renal transplant recipients. Pediatr Nephrol 2006 : 21 : 719 724.
26. Montini G, Murer L, Ghio L, et al. One-year results of basiliximab induction and tacrolimus associated with sequential steroid and MMF treatment in pediatric kidney transplant recipient. Transpl Int 2005 : 18 : 36 42.
27. Armstrong VW, Oellerich M. New developments in the immunosuppressive drug monitoring of cyclosporine, tacrolimus, and azathioprine. Clin Biochem 2001 : 34 : 9 16.
28. Hedayat S, Kershner RP, Su G. Relationship of whole-blood FK506 concentrations to rejection and toxicity in liver and kidney transplants. J Biopharm Stat 1996 : 6 : 411 424.
29. Kershner RP, Fitzsimmons WE. Relationship of FK506 whole blood concentrations and efficacy and toxicity after liver and kidney transplantation. Transplantation 1996 : 62 : 920 926.
30. Braun F, Schutz E, Peters B, et al. Pharmacokinetics of tacrolimus primary immunosuppression in kidney transplant recipients. Transplant Proc 2001 : 33 : 2127 2128.
31. Wallemacq PE, Furlan V, Moller A, et al. Pharmacokinetics of tacrolimus (FK506) in paediatric liver transplant recipients. Eur J Drug Metab Pharmacokinet 1998 : 23 : 367 370.
32. Webb NJ, Stevenson PJ, Lewis MA, Postlethwaite RJ, Bradbury MG, Undre NA. Pharmacokinetics of tacrolimus in paediatric renal transplant recipients. Transplant Proc 2002 : 34 : 1948 1950.
33. Filler G, Feber J, Lepage N, Weiler G, Mai I. Universal approach to pharmacokinetic monitoring of immunosuppressive agents in children. Pediatr Transplant 2002 : 6 : 411 418.
34. Mancinelli LM, Frassetto L, Floren LC, et al. The pharmacokinetics and metabolic disposition of tacrolimus: A comparison across ethnic groups. Clin Pharmacol Ther 2001 : 69 : 24 31.