Drug updated on 7/25/2024
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 immunosuppressant |
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
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Summary
- Tacrolimus (Prograf) is 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.
- The information was derived from 14 systematic reviews/meta-analyses studies focusing on tacrolimus' safety and effectiveness compared to other immunosuppressants.
- Neurologic adverse effects such as tremor, headache, and insomnia were inconsistently correlated with tacrolimus trough concentrations; older age and female gender (especially Black females) showed higher incidences of these side effects.
- Pharmacokinetic variability limits therapeutic drug monitoring's ability to prevent toxicity effectively; developed algorithms improved target concentration ranges but did not significantly reduce toxicity compared to bodyweight-based dosing.
- No significant differences were found between once-daily versus twice-daily tacrolimus regimens regarding clinical outcomes like acute rejection rates or patient mortality in renal transplant patients.
- Combining mTOR inhibitors with reduced tacrolimus exposure appears safer than calcineurin inhibitor avoidance or early steroid withdrawal regimens which show increased rejection rates.
- Genetic polymorphisms such as CYP3A4*22 influence plasma concentrations and dose requirements for tacrolimus; personalized dosing based on genetic markers may improve safety and efficacy profiles over standard practices.
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 |