Abstract
Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generic is a controversial issue. The comparison of clinical and safety outcomes of the generic tacrolimus versus the reference drug ( Prograf) is essential. De Novo transplanted recipients who received the princeps (23patients) were compared with de Novo transplant recipient who received the generic (13patients). We studied the episodes of graft rejection, the drug toxicity, the incidence of infectious complications, glucose abnormalities and number of hospitalizations. There is no significant difference between the two groups in the acute rejection rate, respectively 21.7%, 38.5% (p=0.289) the 1st year, 4.5%, 12.5 %( p=0.46) the 2ndyear, 9.1%, 16.7% (p=0.53) the 3rd year post transplant. The Creatinine rate at month 1, 3, and 1 year were not significantly different between the 2 groups. Infectious complications and NODAT were not significantly different between the 2 groups. The mean number of hospitalizations at 1 year was significantly higher in the generic group (p=0.013). Substitution to a generic formulation of tacrolimus from the innovator product in the kidney transplant recipients was safely implemented.
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