Generic tacrolimus (Pan Graf) in renal transplantation: an experience of 155 recipients in India.

ABSTRACT

BACKGROUND: The safety and efficacy of tacrolimus in transplantation are well established. However, tacrolimus (Pan Graf) has only been available in India for the last 2 years. We conducted this study to assess the safety and efficacy of tacrolimus in living related kidney transplantation. Herein we have reported our experience with tacrolimus as de novo therapy in a living related renal transplant program. MATERIALS AND METHODS: One hundred fifty-five consecutive recipients of living donor renal allografts were included in this study after consent and ethical clearance. Immunosuppression consisted of tacrolimus, mycophenolate mofetil or azathioprine, and steroids. The dose of tacrolimus was adjusted according to levels done on a regular basis. All patients were followed for periods ranging from 3 to 33 months. All episodes of graft dysfunction were evaluated by a graft biopsy. We evaluated the effects of this regimen on the incidence of graft rejection, graft survival, patient survival, and new onset diabetes mellitus. Six patients were diabetic prior to transplantation and 9 patients were hepatitis C virus (HCV) positive. RESULTS: There were 137 male and 18 female patients. The incidence of acute rejection was 3.87%; 17.93% developed new onset diabetes mellitus; and 77.7% of HCV-positive patients and 14.07% of HCV-negative patients developed posttransplantation diabetes mellitus. The patient survival at the current follow-up was 94.19%. CONCLUSION: This generic form of tacrolimus is a safe, effective immunosuppressant in living related renal transplantation.