Abstract

BACKGROUND: Although the once-daily formulation of tacrolimus (ADVAGRAF™) is approved in renal transplantation to be used immediately after surgery, conventional twice-daily formulation offers better flexibility to adjust the dosage of tacrolimus during the initial period of transplantation.

MATERIAL AND METHODS: We retrospectively report here our initial experience with a strategy of an early conversion from PROGRAF™ to ADVAGRAF™ before hospital discharge.

RESULTS: Forty-eight de novo renal transplant recipients were started on PROGRAF™ and then switched to ADVAGRAF™ after a median time of 11 days and 4.5 days, respectively, before discharge. In terms of tacrolimus exposure, great inter-individual heterogeneity was noted, with 56% of patients experiencing a clinically significant modification in post-switch tacrolimus blood trough levels. Modification in post-switch drug exposure was poorly predicted by change in tacrolimus daily dosage. Six-month post-transplant outcome was similar in patients converted to ADVAGRAF™ to that of patients who had remained on PROGRAF™ during the same period of time. Our data suggest that an early conversion from PROGRAF™ to ADVAGRAF™ during the hospital stay may be safely undertaken, provided tacrolimus exposure is tightly monitored in patients.

CONCLUSIONS: This strategy might represent an alternative to the immediate post-transplant introduction of ADVAGRAF™ and needs to be clinically validated in large-scale controlled trials.

Keywords: Drug Monitoring, immunosuppresive agent, Kidney Transplantation, Tacrolimus