FDA: Some Kidney Recipients May Benefit by Relying More on Rapamune

Some kidney transplant recipients who take the combination of cyclosporine and Rapamune to suppress their immune systems may be able to stop taking cyclosporine several months after their surgery, according to the U.S. Food and Drug Administration.

The FDA said patients at low to moderate risk of rejecting the new organ might benefit from a regimen in which they stop taking cyclosporine two to four months after transplant and substitute higher doses of Rapamune.

The combination of cyclosporine and sirolimus, the generic name for Rapamune, is one of several combinations of immunosuppressive drugs used by kidney transplant recipients.

Dr. Mark Cavaille-Coll of the FDA said that in the combination, cyclosporine was associated with some kidney toxicity, and in a clinical trial involving 525 transplant recipients, the ability to stop using cyclosporine helped improve long-term kidney function.

The FDA cautioned that patients who have taken cyclosporine for three months or more after their kidney transplant should not stop the medication without consulting a physician.

The FDA said it now is studying the effects of withdrawing cyclosporine and substituting higher doses of Rapamune in transplant recipients at high-risk of organ rejection.

Other Sources: FDA