Population pharmacokinetics and dosage optimisation of tacrolimus coadministration with Wuzhi capsule in adult liver transplant patients

References

• Berger FA, Mulder MB, Ten Bosch-Dijksman W, van Schaik RHN, Coenen S, de Winter BCM. 2019. Differences in CYP3A genotypes of a liver transplant recipient and the donor liver graft and adjustment of tacrolimus dose. Br J Clin Pharmacol. 85(8):1852–1854.
   PubMed Web of Science ®Google Scholar
• Brunet M, van Gelder T, Åsberg A, Haufroid V, Hesselink DA, Langman L, Lemaitre F, Marquet P, Seger C, Shipkova M, et al. 2019. Therapeutic drug monitoring of tacrolimus-personalized therapy: second consensus report. Ther Drug Monit. 41(3):261–307.
   PubMed Web of Science ®Google Scholar
• Campagne O, Mager DE, Tornatore KM. 2019. Population pharmacokinetics of tacrolimus in transplant recipients: what did we learn about sources of interindividual variabilities? J Clin Pharmacol. 59(3):309–325.
   PubMed Web of Science ®Google Scholar
• Chen Z, Liu F, Zheng N, Guo M, Bao L, Zhan Y, Zhang M, Zhao Y, Guo W, Ding G. 2019. Wuzhi capsule (Schisandra Sphenanthera extract) attenuates liver steatosis and inflammation during non-alcoholic fatty liver disease development. Biomed Pharmacother. 110:285–293.
   PubMed Web of Science ®Google Scholar
• Chen X, Wang D, Xu H, Li Z. 2020a. 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. 45(2):309–317.
   PubMed Web of Science ®Google Scholar
• Chen X, Wang DD, Xu H, Li ZP. 2020b. Initial dosage optimization of tacrolimus in Chinese pediatric patients undergoing kidney transplantation based on population pharmacokinetics and pharmacogenetics. Expert Rev Clin Pharmacol. 13(5):553–561.
   PubMed Web of Science ®Google Scholar
• Chen X, Wang DD, Xu H, Li ZP. 2020c. Optimization of initial dosing scheme of tacrolimus in pediatric refractory nephrotic syndrome patients based on CYP3A5 genotype and coadministration with Wuzhi-capsule. Xenobiotica. 50(5):606–613.
   PubMed Web of Science ®Google Scholar
• Chen X, Wang DD, Xu H, Li ZP. 2020d. Population pharmacokinetics and pharmacogenomics of tacrolimus in Chinese children receiving a liver transplant: initial dose recommendation. Transl Pediatr. 9(5):576–586.
   PubMed Web of Science ®Google Scholar
• Chen X, Wang DD, Xu H, Li ZP. 2020e. Population pharmacokinetics model and initial dose optimization of tacrolimus in children and adolescents with lupus nephritis based on real-world data. Exp Ther Med. 20(2):1423–1430.
   PubMed Web of Science ®Google Scholar
• Chen L, Yang Y, Wang X, Wang C, Lin W, Jiao Z, Wang Z. 2021. Wuzhi capsule dosage affects tacrolimus elimination in adult kidney transplant recipients, as determined by a population pharmacokinetics analysis. Pharmgenomics Pers Med. 14:1093–1106.
   PubMed Web of Science ®Google Scholar
• Cheng S, Tang M, Du J, Yin T. 2020. Effects of antifungal drugs on the plasma concentrations and dosage of tacrolimus in kidney transplant patients. Eur J Hosp Pharm.; ejhpharm-2020-002385.doi:10.1136/ejhpharm-2020-002385
   PubMedGoogle Scholar
• Encke J, Uhl W, Stremmel W, Sauer P. 2004. Immunosuppression and modulation in liver transplantation. Nephrol Dial Transplant. 19 (Suppl 4):iv22–25.
   PubMedGoogle Scholar
• Fukudo M, Yano I, Fukatsu S, Saito H, Uemoto S, Kiuchi T, Tanaka K, Inui K. 2003. Forecasting of blood tacrolimus concentrations based on the Bayesian method in adult patients receiving living-donor liver transplantation. Clin Pharmacokinet. 42(13):1161–1178.
   PubMed Web of Science ®Google Scholar
• Gong Y, Yang M, Sun Y, Li J, Lu Y, Li X. 2020. Population pharmacokinetic analysis of tacrolimus in Chinese cardiac transplant recipients. Eur J Hosp Pharm. 27(e1):e12–e18.
   PubMedGoogle Scholar
• Han Y, Zhou H, Cai J, Huang J, Zhang J, Shi SJ, Liu YN, Zhang Y. 2019. Prediction of tacrolimus dosage in the early period after heart transplantation: a population pharmacokinetic approach. Pharmacogenomics. 20(1):21–35.
   PubMed Web of Science ®Google Scholar
• He Q, Bu F, Zhang H, Wang Q, Tang Z, Yuan J, Lin HS, Xiang X. 2021. Investigation of the impact of CYP3A5 polymorphism on drug-drug interaction between tacrolimus and Schisantherin A/Schisandrin A based on physiologically-based pharmacokinetic modeling. Pharmaceuticals. 14(3):198.
   Web of Science ®Google Scholar
• Ji E, Kim MG, Oh JM. 2018. CYP3A5 genotype-based model to predict tacrolimus dosage in the early postoperative period after living donor liver transplantation. Ther Clin Risk Manag. 14:2119–2126.
   PubMed Web of Science ®Google Scholar
• Jing Y, Kong Y, Hou X, Liu H, Fu Q, Jiao Z, Peng H, Wei X. 2021. Population pharmacokinetic analysis and dosing guidelines for tacrolimus co-administration with Wuzhi capsule in Chinese renal transplant recipients. J Clin Pharm Ther. 46(4):1117–1128.
   PubMed Web of Science ®Google Scholar
• Kirubakaran R, Stocker SL, Hennig S, Day RO, Carland JE. 2020. Population pharmacokinetic models of tacrolimus in adult transplant recipients: a systematic review. Clin Pharmacokinet. 59(11):1357–1392.
   PubMed Web of Science ®Google Scholar
• Kuypers DRJ. 2020. Intrapatient variability of tacrolimus exposure in solid organ transplantation: a novel marker for clinical outcome. Clin Pharmacol Ther. 107(2):347–358.
   PubMed Web of Science ®Google Scholar
• Lee JY, Hahn HJ, Son IJ, Suh KS, Yi NJ, Oh JM, Shin WG. 2006. Factors affecting the apparent clearance of tacrolimus in Korean adult liver transplant recipients. Pharmacotherapy. 26(8):1069–1077.
   PubMed Web of Science ®Google Scholar
• Li J, Chen S, Qin X, Fu Q, Bi H, Zhang Y, Wang X, Liu L, Wang C, Huang M. 2017. Wuzhi tablet (schisandra sphenanthera extract) is a promising tacrolimus-sparing agent for renal transplant recipients who are CYP3A5 expressers: a two-phase prospective study. Drug Metab Dispos. 45(11):1114–1119.
   PubMed Web of Science ®Google Scholar
• Li D, Lu W, Zhu JY, Gao J, Lou YQ, Zhang GL. 2007. Population pharmacokinetics of tacrolimus and CYP3A5, MDR1 and IL-10 polymorphisms in adult liver transplant patients. J Clin Pharm Ther. 32(5):505–515.
   PubMed Web of Science ®Google Scholar
• Lu YX, Su QH, Wu KH, Ren YP, Li L, Zhou TY, Lu W. 2015. A population pharmacokinetic study of tacrolimus in healthy Chinese volunteers and liver transplant patients. Acta Pharmacol Sin. 36(2):281–288.
   PubMed Web of Science ®Google Scholar
• Lu T, Zhu X, Xu S, Zhao M, Huang X, Wang Z, Zhao L. 2019. Dosage optimization based on population pharmacokinetic analysis of tacrolimus in Chinese patients with nephrotic syndrome. Pharm Res. 36(3):45.
   PubMed Web of Science ®Google Scholar
• Mao JJ, Jiao Z, Yun HY, Zhao CY, Chen HC, Qiu XY, Zhong MK. 2018. External evaluation of population pharmacokinetic models for ciclosporin in adult renal transplant recipients. Br J Clin Pharmacol. 84(1):153–171.
   PubMed Web of Science ®Google Scholar
• Monostory K, Tóth K, Kiss Á, Háfra E, Csikány N, Paulik J, Sárváry E, Kóbori L. 2015. Personalizing initial calcineurin inhibitor dosing by adjusting to donor CYP3A-status in liver transplant patients. Br J Clin Pharmacol. 80(6):1429–1437.
   PubMed Web of Science ®Google Scholar
• Muduma G, Saunders R, Odeyemi I, Pollock RF. 2016. Systematic review and meta-analysis of tacrolimus versus ciclosporin as primary immunosuppression after liver transplant. PLOS One. 11(11):e0160421.
   PubMed Web of Science ®Google Scholar
• Oteo I, Lukas JC, Leal N, Suarez E, Valdivieso A, Gastaca M, Ortiz de Urbina J, Calvo R. 2013. Tacrolimus pharmacokinetics in the early post-liver transplantation period and clinical applicability via Bayesian prediction. Eur J Clin Pharmacol. 69(1):65–74.
   PubMed Web of Science ®Google Scholar
• Qin XL, Bi HC, Wang XD, Li JL, Wang Y, Xue XP, Chen X, Wang CX, Xu Le J, Wang YT, et al. 2010. 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. 389(1–2):114–121.
   PubMed Web of Science ®Google Scholar
• Qin XL, Yu T, Li LJ, Wang Y, Gu HM, Wang YT, Huang M, Bi HC. 2013. Effect of long-term co-administration of Wuzhi tablet (Schisandra sphenanthera extract) and prednisone on the pharmacokinetics of tacrolimus. Phytomedicine. 20(3–4):375–379.
   PubMed Web of Science ®Google Scholar
• Sam WJ, Tham LS, Holmes MJ, Aw M, Quak SH, Lee KH, Lim SG, Prabhakaran K, Chan SY, Ho PC. 2006. Population pharmacokinetics of tacrolimus in whole blood and plasma in Asian liver transplant patients. Clin Pharmacokinet. 45(1):59–75.
   PubMed Web of Science ®Google Scholar
• Shao J, Wang C, Fu P, Chen F, Zhang Y, Wei J. 2020. Impact of donor and recipient CYP3A5*3 genotype on tacrolimus population pharmacokinetics in Chinese adult liver transplant recipients. Ann Pharmacother. 54(7):652–661.
   PubMed Web of Science ®Google Scholar
• Staatz CE, Tett SE. 2004. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet. 43(10):623–653.
   PubMed Web of Science ®Google Scholar
• Staatz CE, Willis C, Taylor PJ, Lynch SV, Tett SE. 2003. Toward better outcomes with tacrolimus therapy: population pharmacokinetics and individualized dosage prediction in adult liver transplantation. Liver Transpl. 9(2):130–137.
   PubMed Web of Science ®Google Scholar
• Varghese J, Reddy MS, Venugopal K, Perumalla R, Narasimhan G, Arikichenin O, Shanmugam V, Shanmugam N, Srinivasan V, Jayanthi V, et al. 2014. Tacrolimus-related adverse effects in liver transplant recipients: its association with trough concentrations. Indian J Gastroenterol. 33(3):219–225.
   PubMedGoogle Scholar
• Wang DD, Chen X, Fu M, Zheng QS, Xu H, Li ZP. 2020. Model extrapolation to a real-world dataset: evaluation of tacrolimus population pharmacokinetics and drug interaction in pediatric liver transplantation patients. Xenobiotica. 50(4):371–379.
   PubMed Web of Science ®Google Scholar
• Wang DD, Chen X, Li ZP. 2019. Wuzhi capsule and haemoglobin influence tacrolimus elimination in paediatric kidney transplantation patients in a population pharmacokinetics analysis: a retrospective study. J Clin Pharm Ther. 44(4):611–617.
   PubMed Web of Science ®Google Scholar
• Xin HW, Li Q, Wu XC, He Y, Yu AR, Xiong L, Xiong Y. 2011. Effects of Schisandra sphenanthera extract on the blood concentration of tacrolimus in renal transplant recipients. Eur J Clin Pharmacol. 67(12):1309–1311.
   PubMed Web of Science ®Google Scholar
• Xin HW, Wu XC, Li Q, Yu AR, Zhu M, Shen Y, Su D, Xiong L. 2007. Effects of Schisandra sphenanthera extract on the pharmacokinetics of tacrolimus in healthy volunteers. Br J Clin Pharmacol. 64(4):469–475.
   PubMed Web of Science ®Google Scholar
• Yu M, Liu M, Zhang W, Ming Y. 2018. Pharmacokinetics, pharmacodynamics and pharmacogenetics of tacrolimus in kidney transplantation. Curr Drug Metab. 19(6):513–522.
   PubMed Web of Science ®Google Scholar
• Zhang HX, Sheng CC, Liu LS, Luo B, Fu Q, Zhao Q, Li J, Liu YF, Deng RH, Jiao Z, et al. 2019. Systematic external evaluation of published population pharmacokinetic models of mycophenolate mofetil in adult kidney transplant recipients co-administered with tacrolimus. Br J Clin Pharmacol. 85(4):746–761.
   PubMed Web of Science ®Google Scholar
• Zhao W, Elie V, Roussey G, Brochard K, Niaudet P, Leroy V, Loirat C, Cochat P, Cloarec S, André JL, et al. 2009. Population pharmacokinetics and pharmacogenetics of tacrolimus in de novo pediatric kidney transplant recipients. Clin Pharmacol Ther. 86(6):609–618.
   PubMed Web of Science ®Google Scholar
• Zhao CY, Jiao Z, Mao JJ, Qiu XY. 2016. External evaluation of published population pharmacokinetic models of tacrolimus in adult renal transplant recipients. Br J Clin Pharmacol. 81(5):891–907.
   PubMed Web of Science ®Google Scholar
• Zhu L, Yang J, Zhang Y, Jing Y, Zhang Y, Li G. 2015. Effects of CYP3A5 genotypes, ABCB1 C3435T and G2677T/A polymorphism on pharmacokinetics of Tacrolimus in Chinese adult liver transplant patients. Xenobiotica. 45(9):840–846.
   PubMed Web of Science ®Google Scholar
• Zuo XC, Ng CM, Barrett JS, Luo AJ, Zhang BK, Deng CH, Xi LY, Cheng K, Ming YZ, Yang GP, et al. 2013. Effects of CYP3A4 and CYP3A5 polymorphisms on tacrolimus pharmacokinetics in Chinese adult renal transplant recipients: a population pharmacokinetic analysis. Pharmacogenet Genomics. 23(5):251–261.
   PubMed Web of Science ®Google Scholar