FDA approves new dose for Wyeth transplant drug

Rapamune is the only kidney transplant therapeutic with dosing recommendations specifically for the treatment of high immunologic risk renal transplant recipients. In high immunologic risk patients, it is recommended that a Rapamune-based regimen be used in combination with cyclosporine (CsA) and corticosteroids for the first year following transplantation. The new dosing recommendations 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. High immunologic risk patients are defined as transplant recipients who are black, repeat renal transplant recipients and patients with high-panel reactive antibodies (PRA).

The new labeling was based on clinical data indicating that a Rapamune-based regimen, when initiated post-transplant in combination with CsA, is efficacious in preventing acute rejection in high immunologic risk renal transplant recipients.