Rapamune OK’D for High-Risk Transplants

The U.S. Food and Drug Administration Friday expanded the labeling of Wyeth’s anti-rejection drug Rapamune for high-risk kidney transplants.

The drug, sirolimus, also known as rapamycin, received an indication to treat high-risk kidney-transplant patients — individuals who are African-American, are repeat transplant patients or who are at risk due to a less-than-optimal organ match.

Preventing acute rejection is the highest priority for both physicians and their patients during the first year following kidney transplantation. The new labeling for Rapamune is significant because it provides a needed treatment option for high immunologic risk renal transplant recipients, said John Neylan, a vice president at Wyeth Pharmaceuticals, the developer of Rapamune.

The drug is derived from an organism that thrives in the soil on Easter Island, the South Pacific isle also known as Rapa Nui.

In high-immunologic-risk patients it is recommended that a sirolimus-based regimen be used in combination with cyclosporine and corticosteroids for the first year following transplantation.

The new dosing recommendations for Rapamune also allow for use in combination with antibody induction therapy in this population. High-immunologic-risk patients have a greater likelihood of developing acute rejection than low- to moderate-risk kidney-transplant recipients.