New regimen for kidney transplants

FDA Consumer, July-August, 2003

More than half of all new kidney transplant patients could potentially benefit from a newly approved drug regimen. The FDA has revised the labeling for Rapamune (sirolimus)--an anti-rejection medication--to allow new kidney transplant patients at low to moderate risk of organ rejection to stop taking cyclosporine two to four months after transplantation. By substituting higher levels of Rapamune for cyclosporine, it is hoped that kidney function will improve.

Currently, all kidney transplant patients are treated with a combination of medications that "turn off," or suppress, the body's immune response so that it will not reject the new organ. Three or more drugs, such as cyclosporine and steroids, are typically used. The revised labeling for Rapamune is the first approval of a cyclosporine-sparing regimen for new kidney transplant patients.

The combined use of Rapamune and cyclosporine may carry long-term risks to the transplanted kidney's function, but the newly approved regimen using higher levels of Rapamune may help kidney transplant patients get off cyclosporine sooner without increased risk of organ rejection. Stopping the use of cyclosporine earlier is likely to be associated with improved kidney function.

In 2000, the year the most recent statistics are available, there were more than 14,000 kidney transplants in the United States, according to the National Institute of Diabetes and Digestive and Kidney Diseases.

Wyeth-Ayerst Pharmaceuticals Inc. of Philadelphia is the sponsor of the approved new drug application for Rapamune.