Initial dosage optimization of tacrolimus in Chinese pediatric patients undergoing kidney transplantation based on population pharmacokinetics and pharmacogenetics

References

• Page B, Thervet E, Legendre C, et al. Cryptococcosis after renal transplantation. Transplant Proc. 1995 Feb;27(2):1374.
   PubMed Web of Science ®Google Scholar
• Fay JW, Wingard JR, Antin JH, et al. FK506 (Tacrolimus) monotherapy for prevention of graft-versus-host disease after histocompatible sibling allogenic bone marrow transplantation. Blood. 1996 Apr 15;87(8):3514–3519.
   PubMed Web of Science ®Google Scholar
• Nash RA, Etzioni R, Storb R, et al. Tacrolimus (FK506) alone or in combination with methotrexate or methylprednisolone for the prevention of acute graft-versus-host disease after marrow transplantation from HLA-matched siblings: a single-center study. Blood. 1995 Jun 15;85(12):3746–3753.
   PubMed Web of Science ®Google Scholar
• Musuamba FT, Guy-Viterbo V, Reding R, et al. FK506 in combination with methotrexate for the prevention of graft- versus-host disease after marrow transplantation from matched unrelated donors. Blood. 1996 Nov 1;36(1):3634–3641.
   Google Scholar
• Przepiorka D, Ippoliti C, Khouri I, et al. Tacrolimus and minidose methotrexate for prevention of acute graft- versus-host disease after matched unrelated donor marrow transplantation. Blood. 1996 Dec 1;88(11):4383–4389.
   PubMed Web of Science ®Google Scholar
• Uberti JP, Silver SM, Adams PT, et al. Tacrolimus and methotrexate for the prophylaxis of acute graft-versus-host disease in allogeneic bone marrow transplantation in patients with hematologic malignancies. Bone Marrow Transplant. 1997 Jun;19(12):1233–1238.
   PubMed Web of Science ®Google Scholar
• Nash RA, Antin JH, Karanes C, et al. Phase 3 study comparing methotrexate and tacrolimus with methotrexate and cyclosporine for prophylaxis of acute graft-versus-host disease after marrow transplantation from unrelated donors. Blood. 2000 Sep 15;96(6):2062–2068.
   PubMed Web of Science ®Google Scholar
• Wang D, Chen X, Xu H, et al. Population pharmacokinetics and dosing regimen optimization of tacrolimus in Chinese pediatric hematopoietic stem cell transplantation patients. Xenobiotica. 2020 Feb;50(2):178–185.
   Google Scholar
• Liu B-Y, Chen W-Q, Chen Z-G, et al. The effects of CYP3A5 genetic polymorphisms on serum tacrolimus dose-adjusted concentrations and long-term prognosis in chinese heart transplantation recipients. Eur J Drug Metab Pharmacokinet. 2019 May 13;44(6):771–776.
   Web of Science ®Google Scholar
• Han Y, Zhou H, Cai J, et al. Prediction of tacrolimus dosage in the early period after heart transplantation: a population pharmacokinetic approach. Pharmacogenomics. 2019 Jan;20(1):21–35.
   PubMed Web of Science ®Google Scholar
• Monchaud C, de Winter BC, Knoop C, et al. Population pharmacokinetic modelling and design of a Bayesian estimator for therapeutic drug monitoring of tacrolimus in lung transplantation. Clin Pharmacokinet. 2012 Mar 1;51(3):175–186.
   PubMed Web of Science ®Google Scholar
• Lu YX, Su QH, Wu KH, et al. A population pharmacokinetic study of tacrolimus in healthy Chinese volunteers and liver transplant patients. Acta Pharmacol Sin. 2015 Feb;36(2):281–288.
   PubMed Web of Science ®Google Scholar
• Musuamba FT, Guy-Viterbo V, Reding R, et al. Population pharmacokinetic analysis of tacrolimus early after pediatric liver transplantation. Ther Drug Monit. 2014 Feb;36(1):54–61.
   PubMed Web of Science ®Google Scholar
• Wallin JE, Bergstrand M, Wilczek HE, et al. Population pharmacokinetics of tacrolimus in pediatric liver transplantation: early posttransplantation clearance. Ther Drug Monit. 2011 Dec;33(6):663–672.
   PubMed Web of Science ®Google Scholar
• Yang JW, Liao SS, Zhu LQ, et al. Population pharmacokinetic analysis of tacrolimus early after Chinese pediatric liver transplantation. Int J Clin Pharmacol Ther. 2015 Jan;53(1):75–83.
   PubMed Web of Science ®Google Scholar
• Zhang XQ, Wang ZW, Fan JW, et al. The impact of sulfonylureas on tacrolimus apparent clearance revealed by a population pharmacokinetics analysis in Chinese adult liver-transplant patients. Ther Drug Monit. 2012 Apr;34(2):126–133.
   PubMed Web of Science ®Google Scholar
• Zhu L, Yang J, Zhang Y, et al. Effects of CYP3A5 genotypes, ABCB1 C3435T and G2677T/A polymorphism on pharmacokinetics of Tacrolimus in Chinese adult liver transplant patients. Xenobiotica. 2015;45(9):840–846.
   PubMed Web of Science ®Google Scholar
• Wang DD, Chen X, Fu M, et al. Model extrapolation to a real-world dataset: evaluation of tacrolimus population pharmacokinetics and drug interaction in pediatric liver transplantation patients. Xenobiotica. 2020 Apr;50(4):371–379.
   Google Scholar
• Andreu F, Colom H, Grinyo JM, et al. Development of a population PK model of tacrolimus for adaptive dosage control in stable kidney transplant patients. Ther Drug Monit. 2015 Apr;37(2):246–255.
   PubMed Web of Science ®Google Scholar
• Benkali K, Rostaing L, Premaud A, et al. Population pharmacokinetics and Bayesian estimation of tacrolimus exposure in renal transplant recipients on a new once-daily formulation. Clin Pharmacokinet. 2010 Oct;49(10):683–692.
   PubMed Web of Science ®Google Scholar
• Bergmann TK, Hennig S, Barraclough KA, et al. Population pharmacokinetics of tacrolimus in adult kidney transplant patients: impact of CYP3A5 genotype on starting dose. Ther Drug Monit. 2014 Feb;36(1):62–70.
   PubMed Web of Science ®Google Scholar
• Han N, Ha S, Yun HY, et al. Population pharmacokinetic-pharmacogenetic model of tacrolimus in the early period after kidney transplantation. Basic Clin Pharmacol Toxicol. 2014 May;114(5):400–406.
   PubMed Web of Science ®Google Scholar
• Zhao W, Elie V, Roussey G, et al. Population pharmacokinetics and pharmacogenetics of tacrolimus in de novo pediatric kidney transplant recipients. Clin Pharmacol Ther. 2009 Dec;86(6):609–618.
   PubMed Web of Science ®Google Scholar
• Zuo XC, Ng CM, Barrett JS, et al. Effects of CYP3A4 and CYP3A5 polymorphisms on tacrolimus pharmacokinetics in Chinese adult renal transplant recipients: a population pharmacokinetic analysis. Pharmacogenet Genomics. 2013 May;23(5):251–261.
   PubMed Web of Science ®Google Scholar
• Zhao W, Fakhoury M, Baudouin V, et al. Population pharmacokinetics and pharmacogenetics of once daily prolonged-release formulation of tacrolimus in pediatric and adolescent kidney transplant recipients. Eur J Clin Pharmacol. 2013 Feb;69(2):189–195.
   PubMed Web of Science ®Google Scholar
• Jacobo-Cabral CO, Garcia-Roca P, Romero-Tejeda EM, et al. Population pharmacokinetic analysis of tacrolimus in Mexican paediatric renal transplant patients: role of CYP3A5 genotype and formulation. Br J Clin Pharmacol. 2015 Oct;80(4):630–641.
   PubMed Web of Science ®Google Scholar
• Prytula AA, Cransberg K, Bouts AH, et al. The effect of weight and CYP3A5 genotype on the population pharmacokinetics of tacrolimus in stable pediatric renal transplant recipients. Clin Pharmacokinet. 2016 Sep;55(9):1129–1143.
   PubMed Web of Science ®Google Scholar
• Andrews LM, Hesselink DA, van Gelder T, et al. A population pharmacokinetic model to predict the individual starting dose of tacrolimus following pediatric renal transplantation. Clin Pharmacokinet. 2018 Apr;57(4):475–489.
   PubMed Web of Science ®Google Scholar
• Venkataramanan R, Swaminathan A, Prasad T, et al. Clinical pharmacokinetics of tacrolimus. Clin Pharmacokinet. 1995 Dec;29(6):404–430.
   PubMed Web of Science ®Google Scholar
• Wang D, Lu J, Li Q, et al. Population pharmacokinetics of tacrolimus in pediatric refractory nephrotic syndrome and a summary of other pediatric disease models. Exp Ther Med. 2019 May;17(5):4023–4031.
   PubMed Web of Science ®Google Scholar
• Wang DD, Lu JM, Li Q, et al. Population pharmacokinetics of tacrolimus in paediatric systemic lupus erythematosus based on real-world study. J Clin Pharm Ther. 2018 Aug;43(4):476–483.
   PubMed Web of Science ®Google Scholar
• Kausman JY, Patel B, Marks SD. Standard dosing of tacrolimus leads to overexposure in pediatric renal transplantation recipients. Pediatr Transplant. 2008 May;12(3):329–335.
   PubMed Web of Science ®Google Scholar
• Tang JT, Andrews LM, van Gelder T, et al. Pharmacogenetic aspects of the use of tacrolimus in renal transplantation: recent developments and ethnic considerations. Expert Opin Drug Metab Toxicol. 2016 May;12(5):555–565.
   PubMed Web of Science ®Google Scholar
• Han N, Yun HY, Hong JY, et al. Prediction of the tacrolimus population pharmacokinetic parameters according to CYP3A5 genotype and clinical factors using NONMEM in adult kidney transplant recipients. Eur J Clin Pharmacol. 2013 Jan;69(1):53–63.
   PubMed Web of Science ®Google Scholar
• van Gelder T. Drug interactions with tacrolimus. Drug Saf. 2002;25(10):707–712.
   PubMed Web of Science ®Google Scholar
• Wang -D-D, Chen X, Li Z-P. Wuzhi capsule and haemoglobin influence tacrolimus elimination in paediatric kidney transplantation patients in a population pharmacokinetics analysis: A retrospective study. J Clin Pharm Ther. 2019 Aug;44(4):611–617.
   PubMed Web of Science ®Google Scholar
• Moller A, Iwasaki K, Kawamura A, et al. The disposition of 14C-labeled tacrolimus after intravenous and oral administration in healthy human subjects. Drug Metab Dispos. 1999 Jun;27(6):633–636.
   PubMed Web of Science ®Google Scholar
• Masuda S, Inui K. An up-date review on individualized dosage adjustment of calcineurin inhibitors in organ transplant patients. Pharmacol Ther. 2006 Oct;112(1):184–198.
   PubMed Web of Science ®Google Scholar
• Hebert MF. Contributions of hepatic and intestinal metabolism and P-glycoprotein to cyclosporine and tacrolimus oral drug delivery. Adv Drug Deliv Rev. 1997 Sep 15;27(2–3):201–214.
   PubMed Web of Science ®Google Scholar
• Chen X, Wang -D-D, Xu H, et al. Optimization of initial dosing scheme of tacrolimus in pediatric refractory nephrotic syndrome patients based on CYP3A5 genotype and coadministration with wuzhi-capsule. Xenobiotica. 2020 May;50(5):606–613.
   PubMed Web of Science ®Google Scholar
• 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 Sep;79(3):241–257.
   PubMed Web of Science ®Google Scholar
• Jusko WJ, Piekoszewski W, Klintmalm GB, et al. Pharmacokinetics of tacrolimus in liver transplant patients. Clin Pharmacol Ther. 1995 Mar;57(3):281–290.
   PubMed Web of Science ®Google Scholar
• Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008;48(1):303–332.
   PubMedGoogle Scholar
• Hao G-X, Huang X, Zhang D-F, et al. Population pharmacokinetics of tacrolimus in children with nephrotic syndrome. Br J Clin Pharmacol. 2018 Aug;84(8):1748–1756.
   PubMed Web of Science ®Google Scholar
• Chen X, Wang D, Xu H, et al. Initial dose optimization of tacrolimus for children with systemic lupus erythematosus based on the CYP3A5 polymorphism and coadministration with Wuzhi capsule. J Clin Pharm Ther. 2013 Apr;23(5):309–317.
   Google Scholar
• Anderson BJ, Holford NHG. Tips and traps analyzing pediatric PK data. Pediatric Anesthesia. 2011 Mar;21(3):222–237.
   PubMed Web of Science ®Google Scholar
• Holford NHG. A size standard for pharmacokinetics. Clin Pharmacokinet. 1996 May;30(5):329–332.
   PubMed Web of Science ®Google Scholar
• Savage VM, Deeds EJ, Fontana W. Sizing up allometric scaling theory. PLoS Comput Biol. 2008 Sep 12;4(9):e1000171.
   PubMed Web of Science ®Google Scholar
• Wei H, Tao X, Di P, et al. Effects of traditional chinese medicine wuzhi capsule on pharmacokinetics of tacrolimus in rats. Drug Metab Dispos. 2013 Jul;41(7):1398–1403.
   PubMed Web of Science ®Google Scholar
• Xin H-W, Li Q, Wu X-C, et al. Effects of Schisandra sphenanthera extract on the blood concentration of tacrolimus in renal transplant recipients. Eur J Clin Pharmacol. 2011 Dec;67(12):1309–1311.
   PubMed Web of Science ®Google Scholar
• Xin H-W, Wu X-C, Li Q, et al. Effects of Schisandra sphenanthera extract on the pharmacokinetics of tacrolimus in healthy volunteers. Br J Clin Pharmacol. 2007 Oct;64(4):469–475.
   PubMed Web of Science ®Google Scholar
• Qin X-L, Bi H-C, Wang C-X, et al. Study of the effect of Wuzhi tablet (Schisandra sphenanthera extract) on tacrolimus tissue distribution in rat by liquid chromatography tandem mass spectrometry method. Biomed Chromatogr. 2010 Apr;24(4):399–405.
   PubMed Web of Science ®Google Scholar
• Lampen A, Christians U, Guengerich FP, et al. Metabolism of the immunosuppressant tacrolimus in the small intestine: cytochrome P450, drug interactions, and interindividual variability. Drug Metab Dispos. 1995 Dec;23(12):1315–1324.
   PubMed Web of Science ®Google Scholar
• Vincent SH, Karanam BV, Painter SK, et al. In vitro metabolism of FK-506 in rat, rabbit, and human liver microsomes: identification of a major metabolite and of cytochrome P450 3A as the major enzymes responsible for its metabolism. Arch Biochem Biophys. 1992 May 1;294(2):454–460.
   PubMed Web of Science ®Google Scholar
• Qin XL, Bi HC, Wang XD, et al. Mechanistic understanding of the different effects of Wuzhi Tablet (Schisandra sphenanthera extract) on the absorption and first-pass intestinal and hepatic metabolism of Tacrolimus (FK506). Int J Pharm. 2010 Apr 15;389(1–2):114–121.
   PubMed Web of Science ®Google Scholar
• Campagne O, Mager DE, Tornatore KM. Population pharmacokinetics of tacrolimus in transplant recipients: what did we learn about sources of interindividual variabilities? The Journal of Clinical Pharmacology. 2019 Mar;59(3):309–325.
   PubMed Web of Science ®Google Scholar