Summary

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• 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.