ArticleBritish journal of clinical pharmacology2019
Population pharmacokinetics of immediate- and prolonged-release tacrolimus formulations in liver, kidney and heart transplant recipients.
Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.
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Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Relevance-Based Score for MIPD Model Selection: Systematic Review and External Evaluation of popPK Tacrolimus Models in Adult Transplant Recipients.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- Population Pharmacokinetic Models of Tacrolimus in Adult Transplant Recipients: A Systematic Review.Clinical pharmacokinetics · 2020Pooled it
- Engineering "off-the-shelf" TCR-T cells: A transient mRNA platform for balanced alloreactivity and functionality.Molecular therapy. Oncology · 2026Article
- Population Pharmacokinetic/Pharmacodynamic Model of the Impact of Cumulative Tacrolimus Exposure on Kidney Function After Liver Transplant.Therapeutic drug monitoring · 2026Article
- External evaluation of population pharmacokinetic models for tacrolimus in kidney transplant recipients: implications for model-informed precision dosing.BMC nephrology · 2026Article
- Safety of tacrolimus during lactation: an exploratory retrospective analysis in a small Japanese cohort.International breastfeeding journal · 2026Article
- Model Informed Precision Dosing of Tacrolimus in Children Following Heart Transplant.Journal of clinical pharmacology · 2026Article
- Machine learning driven precision medicine in tacrolimus dosing: current research and future perspectives in liver and kidney transplantation.Frontiers in immunology · 2026Review
- Article
- Machine-learning model to predict the tacrolimus concentration and suggest optimal dose in liver transplantation recipients: a multicenter retrospective cohort study.Scientific reports · 2024Article
- Tacrolimus-induced posterior reversible encephalopathy syndrome following liver transplantation.World journal of transplantation · 2024Article
- Guiding the starting dose of the once-daily formulation of tacrolimus in "Frontiers in pharmacology · 2024Article
- Adaptation of a population pharmacokinetic model to inform tacrolimus therapy in heart transplant recipients.British journal of clinical pharmacology · 2023Article
- Genotype-guided model significantly improves accuracy of tacrolimus initial dosing after liver transplantation.EClinicalMedicine · 2023Article
- Sensitivity of estimated tacrolimus population pharmacokinetic profile to assumed dose timing and absorption in real-world data and simulated data.British journal of clinical pharmacology · 2022Article
- Pharmacokinetics of immediate and sustained-release formulations of paroxetine: Population pharmacokinetic approach to guide paroxetine personalized therapy in chinese psychotic patients.Frontiers in pharmacology · 2022Article
- Predictive Performance of Published Tacrolimus Population Pharmacokinetic Models in Thai Kidney Transplant Patients.European journal of drug metabolism and pharmacokinetics · 2022Article
- Pharmacokinetics/pharmacodynamics of polymyxin B in patients with bloodstream infection caused by carbapenem-resistantFrontiers in pharmacology · 2022Article
- Immunosuppressive Potential of Activated Human Amniotic Cells in an Experimental Murine Model of Skin Allo- and Xenotransplantation.Frontiers in medicine · 2021Article
- Conversion from Standard-Release Tacrolimus to MeltDoseJournal of clinical medicine · 2020Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsDevelop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice-daily, immediate-release (IR-T; Prograf) and/or once-daily, prolonged-release (PR-T; Advagraf or Astagraf XL) tacrolimus.
methodsTacrolimus concentration-time profiles were analysed from 8 Phase II studies in adult and paediatric liver, kidney and heart transplant patients receiving IR-T and/or PR-T. A tacrolimus population pharmacokinetic model, including identification of significant covariates, was developed using NONMEM.
resultsOverall, 23,176 tacrolimus concentration records were obtained from 408 patients. A 2-compartment model with first-order absorption and elimination described the concentration-time profiles. Tacrolimus absorption rate was 50% slower with PR-T vs IR-T. Tacrolimus apparent oral clearance was 44.3 L/h in Whites and 59% higher in Asians. Tacrolimus central volume of distribution was 108 L in males and 55% lower in females; trough concentrations were similar between formulations. Tacrolimus relative bioavailability was similar between formulations (geometric mean ratio PR-T:IR-T 95%, 90% confidence intervals: 89%, 101%). Asians had 83% and 51% higher relative bioavailability than Whites and Blacks, respectively, for IR-T and PR-T. Whites had 49% and 77% higher relative bioavailability than Blacks for PR-T and IR-T, respectively. Blacks had 52% lower relative bioavailability than Whites and Asians for IR-T and PR-T. Type of organ transplanted and patient population (adult/paediatric) did not have a significant effect on tacrolimus pharmacokinetics.
conclusionsThis population pharmacokinetic model described data from transplant recipients who received IR-T and/or PR-T. Tacrolimus trough concentrations and relative bioavailability were similar between formulations, supporting 1 mg:1 mg conversion from Prograf to Advagraf/Astagraf XL in clinical practice.
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