Population pharmacokinetics and pharmacogenetics of once daily prolonged-release formulation of tacrolimus in pediatric and adolescent kidney transplant recipients

European Journal of Clinical Pharmacology

Volumn 69, Issue 2, 2013, Pages 189-195

  Zhao, Wei ^a,b   Fakhoury, May ^a   Baudouin, Véronique ^a   Storme, Thomas ^a   Maisin, Anne ^a   Deschênes, Georges ^a   Jacqz Aigrain, Evelyne ^a,b,c  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b INSERM   (France)

^c HÔPITAL ROBERT DEBRÉ   (France)

Author keywords

CYP3A5; Kidney transplantation; Once daily; Pediatric pharmacology; Pediatrics; Pharmacogenetics; Population pharmacokinetics; Prolonged release formulation; Tacrolimus

Indexed keywords

CYTOCHROME P450 3A5; TACROLIMUS;

ADOLESCENT; ADULT; ARTICLE; CHILD; CLINICAL ARTICLE; COMPARTMENT MODEL; CONTROLLED RELEASE FORMULATION; CYP3A5 GENE; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; FEMALE; GENETIC POLYMORPHISM; GRAFT RECIPIENT; HUMAN; KIDNEY TRANSPLANTATION; MALE; PEDIATRICS; PHARMACOGENETICS; PRESCHOOL CHILD; PRIORITY JOURNAL; PROLONGED RELEASE FORMULATION; SCHOOL CHILD;

ADOLESCENT; ADULT; CHILD; CHILD, PRESCHOOL; CYTOCHROME P-450 CYP3A; DELAYED-ACTION PREPARATIONS; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MODELS, BIOLOGICAL; POLYMORPHISM, GENETIC; TACROLIMUS; YOUNG ADULT;

EID: 84873719058     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-012-1330-6     Document Type: Article

References (29)

1. Dobbels F, Ruppar T, De Geest S, Decorte A, Van Damme-Lombaerts R, Fine RN (2010) Adherence to the immunosuppressive regimen in pediatric kidney transplant recipients: a systematic review. Pediatr Transplant 14(5):603-613
2. Weng FL, Israni AK, Joffe MM et al (2005) Race and electronically measured adherence to immunosuppressive medications after deceased donor renal transplantation. J Am Soc Nephrol 16(6):1839-1848 (Pubitemid 41716492)
3. European Medicines Agency. Advagraf 0.5 mg prolonged-release hard capsules: Summary of product characteristics [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/000712/WC500022234.pdf [assessed in 22/03/2012]
4. Benkali K, Rostaing L, Premaud A et al (2010) Population pharmacokinetics and Bayesian estimation of tacrolimus exposure in renal transplant recipients on a new once-daily formulation. Clin Pharmacokinet 49(10):683-692
5. Wlodarczyk Z, Squifflet JP, Ostrowski M et al (2009) Pharmacokinetics for once- versus twice-daily tacrolimus formulations in de novo kidney transplantation: a randomized, open-label trial. Am J Transplant 9(11):2505-2513
6. Glowacki F, Lionet A, Hammelin JP et al (2011) Influence of Cytochrome P450 3A5 (CYP3A5) Genetic Polymorphism on the Pharmacokinetics of the Prolonged-Release, Once-Daily Formulation of Tacrolimus in Stable Renal Transplant Recipients. Clin Pharmacokinet 50(7):451-459
7. European Medicines Agency. Advagraf: scientific discussion [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR- Scientific-Discussion/human/000712/WC500022237.pdf [assessed in 22/03/2012]
8. Barraclough KA, Isbel NM, Johnson DW, Campbell SB, Staatz CE (2011) Once- versus twice-daily tacrolimus: are the formulations truly equivalent? Drugs 71(12):1561-1577
9. Heffron TG, Pescovitz MD, Florman S et al (2007) Once-daily tacrolimus extended-release formulation: 1-year post-conversion in stable pediatric liver transplant recipients. Am J Transplant 7(6):1609-1615 (Pubitemid 46776251)
10. Staatz CE, Goodman LK, Tett SE (2010) Effect of CYP3A and ABCB1 single nucleotide polymorphisms on the pharmacokinetics and pharmacodynamics of calcineurin inhibitors: Part I. Clin Pharmacokinet 49(3):141-175
11. Staatz CE, Goodman LK, Tett SE (2010) Effect of CYP3A and ABCB1 single nucleotide polymorphisms on the pharmacokinetics and pharmacodynamics of calcineurin inhibitors: Part II. Clin Pharmacokinet 49(4):207-221
12. Zhao W, Fakhoury M, Jacqz-Aigrain E (2010) Developmental pharmacogenetics of immunosuppressants in pediatric organ transplantation. Ther Drug Monit 32(6):688-699
13. de Wildt SN, van Schaik RH, Soldin OP et al (2011) The interactions of age, genetics, and disease severity on tacrolimus dosing requirements after pediatric kidney and liver transplantation. Eur J Clin Pharmacol 67(12):1231-1241
14. Zhao W, Elie V, Roussey G et al (2009) Population pharmacokinetics and pharmacogenetics of tacrolimus in de novo pediatric kidney transplant recipients. Clin Pharmacol Ther 86(6):609-618
15. Staatz CE, Tett SE (2007) Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Pharmacokinet 46(1):13-58 (Pubitemid 46091591)
16. Rousseau A, Léger F, Le Meur Y et al (2004) Population pharmacokinetic modeling of oral cyclosporin using NONMEM: comparison of absorption pharmacokinetic models and design of a Bayesian estimator. Ther Drug Monit 26(1):23-30 (Pubitemid 38140906)
17. Zhao W, Fakhoury M, Deschênes G et al (2010) Population pharmacokinetics and pharmacogenetics of mycophenolic acid following administration of mycophenolate mofetil in de novo pediatric renal-transplant patients. J Clin Pharmacol 50(11):1280-1291
18. Savic RM, Jonker DM, Kerbusch T, Karlsson MO (2007) Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies. J Pharmacokinet Pharmacodyn 34(5):711-726 (Pubitemid 47477040)
19. Anderson BJ, Holford NH (2008) Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol 48:303-332 (Pubitemid 351738156)
20. Lindbom L, Ribbing J, Jonsson EN (2004) Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed 75(2):85-94 (Pubitemid 38798039)
21. Brendel K, Comets E, Laffont C, Laveille C, Mentré F (2006) Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res 23(9):2036-2049
22. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO (2011) Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J 13(2):143-151
23. Comets E, Brendel K, Mentré F (2008) Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the npde add-on package for R. Comput Methods Programs Biomed 90(2):154-166
24. Cross SA, Perry CM (2007) Tacrolimus once-daily formulation: in the prophylaxis of transplant rejection in renal or liver allograft recipients. Drugs 67(13):1931-1943 (Pubitemid 47347405)
25. Kim JS, Aviles DH, Silverstein DM, Leblanc PL, Matti VV (2005) Effect of age, ethnicity, and glucocorticoid use on tacrolimus pharmacokinetics in pediatric renal transplant patients. Pediatr Transplant 9(2):162-169 (Pubitemid 40476842)
26. Montini G, Ujka F, Varagnolo C et al (2006) The pharmacokinetics and immunosuppressive response of tacrolimus in paediatric renal transplant recipients. Pediatr Nephrol 21(5):719-724
27. Fukudo M, Yano I, Masuda S et al (2006) Population pharmacokinetic and pharmacogenomic analysis of tacrolimus in pediatric living-donor liver transplant recipients. Clin Pharmacol Ther 80(4):331-345 (Pubitemid 44479749)
28. Barry A, Levine M (2010) A systematic review of the effect of CYP3A5 genotype on the apparent oral clearance of tacrolimus in renal transplant recipients. Ther Drug Monit 32(6):708-714
29. Woillard JB, de Winter BC, Kamar N, Marquet P, Rostaing L, Rousseau A (2011) Population pharmacokinetic model and Bayesian estimator for two tacrolimus formulations-twice daily Prograf and once daily Advagraf. Br J Clin Pharmacol 71(3):391-402