ZORTRESS^® (everolimus) Tablets is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant, administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and corticosteroids. Therapeutic drug monitoring of everolimus and cyclosporine is recommended for all patients.

Limitations of Use: In patients at high immunologic risk, the safety and efficacy of ZORTRESS have not been established. Use of ZORTRESS for the prophylaxis of organ rejection in transplanted organs other than kidney has not been established. Standard doses of cyclosporine should be avoided with ZORTRESS in order to reduce the risk of nephrotoxicity. The safety and efficacy of ZORTRESS have not been established in pediatric patients (<18 years).