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Systematic conversion to generic tacrolimus in stable kidney transplant recipients
Staffan Rosenborg1, Annica Nordström2, Tora Almquist3
1Department of Clinical Pharmacology , Karolinska University Hospital , Stockholm , Sweden ; Department of Renal Medicine , Karolinska University Hospital , Stockholm , Sweden.
Clinical Kidney Journal
|June 20, 2014
Summary
Stable kidney transplant patients can safely switch from Prograf® to generic tacrolimus (Tacrolimus Sandoz®) with close monitoring. This conversion significantly reduces drug costs while maintaining patient safety and renal function.
Area of Science:
- Nephrology
- Pharmacology
- Transplantation Medicine
Background:
- Tacrolimus (Prograf®) is essential for immunosuppression in renal transplant recipients.
- Generic tacrolimus preparations are available in Europe, but clinical conversion data in patients is limited.
- Tacrolimus represents a significant portion of drug expenditure for renal patients in the Stockholm area.
Purpose of the Study:
- To assess the safety and efficacy of switching renal transplant patients from Prograf® to generic tacrolimus (Tacrolimus Sandoz®).
- To evaluate changes in renal function (eGFR) and tacrolimus dosage requirements post-conversion.
- To calculate potential drug cost savings associated with using generic tacrolimus.
Main Methods:
- Prospective quality assurance study involving renal transplant patients.
- Monitoring of plasma creatinine and tacrolimus trough concentrations before and after conversion.
- Calculation of estimated glomerular filtration rate (eGFR) pre- and post-switch.
Main Results:
- Sixty-three patients were analyzed; mean tacrolimus trough concentrations remained stable post-conversion (ratio 1.02).
- No significant changes in eGFR were observed in any patient.
- A 23% reduction in daily drug cost was achieved, equating to approximately €3.60 per daily dose.
Conclusions:
- Conversion from Prograf® to Tacrolimus Sandoz® is safe for stable renal transplant patients.
- Close monitoring of tacrolimus levels and renal function is crucial during conversion.
- The switch to generic tacrolimus offers substantial cost savings for healthcare systems.
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