Drug updated on 11/1/2024
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. 4. 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in a reduced tacrolimus regimen but increased rejection rates when calcineurin inhibitors were avoided or steroids withdrawn early.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 |