Drug updated on 9/5/2024
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.
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Summary
- Prograf (tacrolimus) 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.
- This summary is based on the review of 14 systematic review(s)/meta-analysis(es). [1-14]
- Once-daily vs. Twice-daily Tacrolimus in Kidney Transplantation: No significant differences in biopsy-confirmed acute rejection rates (RR, 0.91; 95% CI, 0.73-1.13) or renal function (SMD, -0.03; 95% CI, -0.12 to 0.07), with similar risk profiles for graft failure, death, and adverse events. 4. mTOR Inhibitors vs. Calcineurin Inhibitors: mTOR inhibitors may allow reduced tacrolimus exposure regimens; however, calcineurin inhibitor avoidance and early steroid withdrawal regimens show increased rejection rates compared to tacrolimus-based regimens.
- CYP3A4*22 Polymorphism: Associated with higher dose-adjusted tacrolimus trough concentrations and lower daily dose requirements.
- Tacrolimus and Mycophenolate Mofetil (MMF) in Liver Transplantation: Combination therapy is associated with a lower risk of acute cellular rejection (RD=-0.11; p=0.001) compared to tacrolimus alone, with similar adverse event risks compared to cyclosporine plus MMF.
- Neurologic Adverse Effects: Higher prevalence of tremor, headache, and insomnia with supratherapeutic tacrolimus levels, particularly in females, especially Black females, and older patients.
- Nephrotoxicity and Post-Transplant Diabetes Mellitus: High pharmacokinetic variability of tacrolimus necessitates therapeutic drug monitoring to prevent under- or overexposure; no reduction in toxicity observed with dosing algorithms compared to bodyweight-based dosing.
- There is no population types or subgroups information available in the reviewed studies.
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 |