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 with corticosteroids. Therapeutic drug monitoring of everolimus and cyclosporine is recommended for all patients.
Limitations of Use: The safety and efficacy of ZORTRESS has not been established in the following populations:
- Kidney transplant patients at high immunologic risk
- Recipients of transplanted organs other than kidney and liver
- Pediatric patients (<18 years)