Drug updated on 12/11/2024
Dosage Form | Capsule (oral; 0.5 mg, 1 mg, 5 mg) Injection (intravenous; 5mg/mL) Granule (oral; 0.2 mg [1 mg]) |
Drug Class | Calcineurin inhibitor immunosuppressants |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants.
Latest News
Summary
- This summary is based on the review of 16 systematic review(s)/meta-analysis(es). [1-16]
- Combining genotype-informed and pharmacokinetic model-based dosing for tacrolimus in pediatric solid organ transplant (SOT) recipients shows potential for dosing accuracy, though evidence on the optimization of initial and subsequent doses remains limited.
- GLP-1 receptor agonists (GLP-1RAs) significantly reduced urine protein ratio and hemoglobin A1c levels in kidney transplant recipients (KTRs) without impacting tacrolimus levels, suggesting possible benefits for metabolic and glycemic control in this population.
- Mammalian target of rapamycin (mTOR) inhibitors were effective in a reduced tacrolimus regimen but increased rejection rates when calcineurin inhibitors were avoided or steroids withdrawn early. Once-daily tacrolimus was comparable to twice-daily formulations in acute rejection and renal function outcomes for de novo renal transplant patients.
- The presence of the CYP3A4*22 allele was associated with higher plasma dose-adjusted trough concentrations (C(0)/D) of tacrolimus, indicating that lower doses may achieve therapeutic levels, supporting dose individualization based on genetic polymorphisms.
- Tacrolimus is associated with nephrotoxicity, new-onset diabetes after transplantation (NODAT), and gastrointestinal toxicity; pharmacokinetic variability within and between individuals complicates management despite therapeutic drug monitoring.
- GLP-1 receptor agonists (GLP-1RAs) in kidney transplant recipients had side effects including nausea and vomiting (17.6%), diarrhea (7.6%), and injection site pain (5.4%).
- Belatacept increased risks of acute rejection and certain infections compared to tacrolimus, while mTOR inhibitors combined with reduced-dose tacrolimus showed increased rejection rates without higher rates of graft failure or death.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Prograf (tacrolimus) Prescribing Information. | 2023 | Astellas Pharma US, Inc., Northbrook, IL |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
The second international consensus guidelines on the management of bk polyomavirus in kidney transplantation | 2024 | Transplantation |
Imlifidase for kidney transplantation of highly sensitized patients with a positive crossmatch: The French consensus guidelines | 2023 | Transplant International |
Population pharmacokinetic analysis and dosing guidelines for tacrolimus co-administration with Wuzhi capsule in Chinese renal transplant recipients | 2021 | Journal of Clinical Pharmacy and Therapeutics |