Tacrolimus: the new antirejection drugTacrolimus: The New Anti-Rejection Drug for Liver Transplant RecipientsC.L.A.S.S. Notes, Fall 1995 -- Tacrolimus is the first new medication since cyclosporine for liver transplants in both adults and children. Previously designated FK506, tacrolimus is also known by the trade name Prograf®. It is an immunosuppressive drug which blocks the immune system from recognizing and destroying a transplanted liver. Today, tacrolimus is being used more often at liver transplant centers as both an initial and maintenance immunosuppressive. Tacrolimus was licensed to Fujisawa, USA, on April 8, 1994, by the US Food and Drug Administration.In 1984, tacrolimus was discovered as a derivative of a fungus growing in Japan. By 1989 it was being used in experiments to treat rejection in liver transplant patients in Pittsburgh. Recently, two large trials were completed in the U.S. (12 centers, 520 patients) and Europe (8 centers and 545 patients). Compared to cyclosporine, tacrolimus was as effective with regard to both patient and graft survival outcomes. What made tacrolimus particularly attractive was that the incidence of rejection and the need for additional steroids (prednisone) or OKT3 (an antibody made against certain white blood cells in the human immune system that recognizes transplanted organs and causes rejection) was considerably less in the tacrolimus patients. Side effects were similar in both groups with regard to kidney dysfunction. The tacrolimus patients had lower cholesterol levels and fewer problems of high blood pressure compared to cyclosporine.
