FDA ( U.S. Food and Drug Administration ) approved Prograf ( Tacrolimus ), a drug for the prevention of graft rejection in the recipients of heart transplants.

Prograf capsules and Prograf for injection, the first products approved in the United States for heart transplantation in eight years, had been previously approved for the prevention of graft rejection in the recipients of liver and kidney transplants.

Prograf acts by a mechanism similar to Cyclosporine, another immunosuppressant used to prevent transplant rejection. Thus Prograf offers an alternative to Cyclosporine for use in certain combination immunosuppressive regimens in liver, kidney and heart transplantation.

The safety and effectiveness of Prograf-based and Cyclosporine-based immunosuppression in heart transplantation were compared in two trials, one of which was conducted in Europe and one in the U.S.

In the European trial, the survival of patients and grafts 18 months after the transplantation in the Prograf group ( 91.7% ) was similar to the Cyclosporine group ( 89.8% ).

In a U.S. study, patient and graft survival at 12 months after transplantation in the Prograf group ( 93.5% ) was similar to the Cyclosporine group ( 86.1% ).

The use of Prograf is associated with increased risk or neurotoxicity, renal function impairment, infection, and post-transplant diabetes mellitus. Like most combination immunosuppressive regimens used in solid organ transplantation, the use of Prograf-based combination immunosuppression is associated with an increased risk of malignancies, notably of non-melanoma skin cancers.

Source: FDA, 2006


XagenaMedicine2006