Population pharmacokinetics of tacrolimus in pediatric liver transplantation: Early posttransplantation clearance

Therapeutic Drug Monitoring

Volumn 33, Issue 6, 2011, Pages 663-672

  Wallin, Johan E ^a,b   Bergstrand, Martin ^a   Wilczek, HenrykE ^c   Nydert, Per S ^d   Karlsson, Mats O ^a   Staatz, Christine E ^a,e  

^a UPPSALA UNIVERSITY   (Sweden)

^b ELI LILLY AND COMPANY   (United States)

^c KAROLINSKA INSTITUTE   (Sweden)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^e UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Bayesian forecasting; Immunosupression; Population pharmacokinetics; Tacrolimus; Therapeutic drug monitoring

Indexed keywords

AZATHIOPRINE; CORTICOSTEROID; TACROLIMUS;

ALLOMETRY; ARTICLE; BAYES THEOREM; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG CLEARANCE; EXTERNAL VALIDITY; FEMALE; GRAFT RECIPIENT; HUMAN; INFANT; INTERNAL VALIDITY; LIVER TRANSPLANTATION; MALE; PERFORMANCE; POSTOPERATIVE PERIOD; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD;

ADOLESCENT; BAYES THEOREM; CHILD; CHILD, PRESCHOOL; COMPUTER SIMULATION; DRUG ADMINISTRATION SCHEDULE; DRUG MONITORING; FEMALE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INFANT; INTESTINAL ABSORPTION; LIVER TRANSPLANTATION; MALE; MEDICAL RECORDS; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL; POSTOPERATIVE PERIOD; PRACTICE GUIDELINES AS TOPIC; RETROSPECTIVE STUDIES; TACROLIMUS;

EID: 84856078406     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e31823415cc     Document Type: Article

References (47)

1. MacFarlane GD, Venkataramanan R, McDiarmid SV, et al. Therapeutic drug monitoring of tacrolimus in pediatric liver transplant patients. Pediatr Transplant. 2001;5:119-124. (Pubitemid 32298572)
2. Antignac M, Hulot JS, Boleslawski E, et al. Population pharmacokinetics of tacrolimus in full liver transplant patients: modelling of the postoperative clearance. Eur J Clin Pharmacol. 2005;61:409-416. (Pubitemid 41569318)
3. Fukatsu S, Yano I, Igarashi T, et al. Population pharmacokinetics of tacrolimus in adult recipients receiving living-donor liver transplantation. Eur J Clin Pharmacol. 2001;57:479-484.
4. Macchi-Andanson M, Charpiat B, Jelliffe RW, et al. Failure of traditional trough levels to predict tacrolimus concentrations. Ther Drug Monit. 2001;23:129-133. (Pubitemid 32240139)
5. Mekki Q, Lee C. Population pharmacokinetics of tacrolimus (FK506) in liver transplant patients. J Clin Pharmacol. 1994;55:162.
6. Sam WJ, Tham LS, Holmes MJ, et al. Population pharmacokinetics of tacrolimus in whole blood and plasma in Asian liver transplant patients. Clin Pharmacokinet. 2006;45:59-75. (Pubitemid 43145015)
7. Staatz CE, Willis C, Taylor PJ, et al. Toward better outcomes with tacrolimus therapy: population pharmacokinetics and individualized dosage prediction in adult liver transplantation. Liver Transpl. 2003;9:130-137. (Pubitemid 36204563)
8. Fukudo M, Yano I, Masuda S, et al. Population pharmacokinetic and pharmacogenomic analysis of tacrolimus in pediatric living-donor liver transplant recipients. Clin Pharmacol Ther. 2006;80:331-345. (Pubitemid 44479749)
9. Garcia Sanchez MJ, Manzanares C, Santos-Buelga D, et al. Covariate effects on the apparent clearance of tacrolimus in paediatric liver transplant patients undergoing conversion therapy. Clin Pharmacokinet. 2001;40:63-71. (Pubitemid 32182114)
10. Sam WJ, Aw M, Quak SH, et al. Population pharmacokinetics of tacrolimus in Asian paediatric liver transplant patients. Br J Clin Pharmacol. 2000;50:531-541. (Pubitemid 32010014)
11. Staatz CE, Taylor PJ, Lynch SV, et al. Population pharmacokinetics of tacrolimus in children who receive cut-down or full liver transplants. Transplantation. 2001;72:1056-1061. (Pubitemid 32924077)
12. Yasuhara M, Hashida T, Toraguchi M, et al. Pharmacokinetics and pharmacodynamics of FK 506 in pediatric patients receiving living-related donor liver transplantations. Transplant Proc. 1995;27:1108-1110.
13. Fernandez de Gatta MM, Garcia MJ, Lanao JM, et al. Bayesian forecasting in paediatric populations. Clin Pharmacokinet. 1996;31:325-330. (Pubitemid 26366462)
14. Dumont RJ, Ensom MH. Methods for clinical monitoring of cyclosporin in transplant patients. Clin Pharmacokinet. 2000;38:427-447. (Pubitemid 30265262)
15. Proost JH. Adaptive control of drug dosage regimens using maximum a posteriori probability Bayesian fitting. Int J Clin Pharmacol Ther. 1995;33:531-536.
16. Thomson AH. Bayesian feedback methods for optimising therapy. Clin Neuropharmacol. 1992;15(suppl 1, pt A): 245A-246A.
17. Antignac M, Barrou B, Farinotti R, et al. Population pharmacokinetics and bioavailability of tacrolimus in kidney transplant patients. Br J Clin Pharmacol. 2007;64:750-757. (Pubitemid 350222052)
18. Staatz C, Taylor P, Tett S. Low tacrolimus concentrations and increased risk of early acute rejection in adult renal transplantation. Nephrol Dial Transplant. 2001;16:1905-1909. (Pubitemid 32821425)
19. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet. 2004;43:623-653. (Pubitemid 38981845)
20. Hu RH, Lee PH, Tsai MK. Clinical influencing factors for daily dose, trough level, and relative clearance of tacrolimus in renal transplant recipients. Transplant Proc. 2000;32:1689-1692.
21. Molinaro M, Regazzi MB, Pasquino S, et al. Pharmacokinetics of tacrolimus during the early phase after heart transplantation. Transplant Proc. 2001;33:2386-2389. (Pubitemid 33762751)
22. FDA. Prograf (Astellas) Drug Label (NDA) 050708. In: CDER, ed; 2006.
23. Siemens. EMIT 2000 Tacrolimus Assay Product Info. Siemens Healthcare Diagnostics. Available at: www.siemens.com/diagnostics. 2007.
24. Taylor PJ, Jones A, Balderson GA, et al. Sensitive, specific quantitative analysis of tacrolimus (FK506) in blood by liquid chromatographyelectrospray tandem mass spectrometry. Clin Chem. 1996;42:279-285. (Pubitemid 26063884)
25. Staatz CE, Taylor PJ, Tett SE. Comparison of an ELISA and an LC/MS/MS method for measuring tacrolimus concentrations and making dosage decisions in transplant recipients. Ther Drug Monit. 2002;24:607-615.
26. Jusko WJ, Piekoszewski W, Klintmalm GB, et al. Pharmacokinetics of tacrolimus in liver transplant patients. Clin Pharmacol Ther. 1995;57:281-290.
27. Lindbom L, Pihlgren P, Jonsson EN. PsN-Toolkit-a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed. 2005;79:241-257. (Pubitemid 41196689)
28. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed. 2004;75:85-94. (Pubitemid 38798039)
29. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9:503-512.
30. Jonsson EN, Karlsson MO. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed. 1999;58:51-64. (Pubitemid 29049052)
31. Magnusson MO, Dahl ML, Cederberg J, et al. Pharmacodynamics of carbamazepine-mediated induction of CYP3A4, CYP1A2, and Pgp as assessed by probe substrates midazolam, caffeine, and digoxin. Clin Pharmacol Ther. 2008;84:52-62. (Pubitemid 351861485)
32. James W. Research on Obesity. London, UK: Her Majesty's Stationery Office; 1976.
33. Schwartz GJ, Haycock GB, Edelmann CM Jr, et al. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics. 1976;58:259-263.
34. Karlsson MO, Savic RM. Diagnosing model diagnostics. Clin Pharmacol Ther. 2007;82:17-20. (Pubitemid 46944205)
35. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 2011;13:143-151.
36. Hooker AC, Staatz CE, Karlsson MO. Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm Res. 2007;24:2187-2197. (Pubitemid 350060706)
37. Wallemacq PE, Verbeeck RK. Comparative clinical pharmacokinetics of tacrolimus in paediatric and adult patients. Clin Pharmacokinet. 2001;40:283-295. (Pubitemid 32458154)
38. Christiaans M, van Duijnhoven E, Beysens T, et al. Effect of breakfast on the oral bioavailability of tacrolimus and changes in pharmacokinetics at different times posttransplant in renal transplant recipients. Transplant Proc. 1998;30:1271-1273. (Pubitemid 28309568)
39. Lemahieu WP, Maes BD, Vanrenterghem Y. Different evolution of trough and dose levels during the first year after transplantation for tacrolimus versus cyclosporine. Transplant Proc. 2005;37:2051-2053. (Pubitemid 40956370)
40. Pou L, Brunet M, Andres I, et al. Influence of posttransplant time on dose and concentration of tacrolimus in liver transplant patients. Transpl Int. 1998;11(suppl 1): S270-S271. (Pubitemid 128683557)
41. Undre NA, Schafer A. Factors affecting the pharmacokinetics of tacrolimus in the first year after renal transplantation. European Tacrolimus Multicentre Renal Study Group. Transplant Proc. 1998;30:1261-1263. (Pubitemid 28309564)
42. Wallin JE, Friberg LE, Fasth A, et al. Population pharmacokinetics of tacrolimus in pediatric hematopoietic stem cell transplant recipients: new initial dosage suggestions and a model-based dosage adjustment tool. Ther Drug Monit. 2009;31:457-466.
43. Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: general principles. Eur J Pediatr. 2006;165:741-746. (Pubitemid 44440510)
44. Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: modelling covariate effects. Eur J Pediatr. 2006;165:819-829. (Pubitemid 44627767)
45. Holford NH. A size standard for pharmacokinetics. Clin Pharmacokinet. 1996;30:329-332. (Pubitemid 26177179)
46. Kleiber M. Body size and metabolic rate. Physiol Rev. 1947;27:511-541.
47. Anglicheau D, Legendre C, Beaune P, et al. Cytochrome P450 3A polymorphisms and immunosuppressive drugs: an update. Pharmacogenomics. 2007;8:835-849. (Pubitemid 47288980)