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Outline
What is the generic name?
EVEROLIMUS
What is the Trade Name for EVEROLIMUS?
Zortress
What are the Indications for EVEROLIMUS?
- 1 INDICATIONS AND USAGE • Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: • Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1 ) • Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2 , 5.5 ) Limitations of Use ( 1.3 ) Safety and efficacy have not been established in the following: • Kidney transplant patients at high immunologic risk ( 1.3 ) • Recipients of transplanted organs other than kidney or liver ( 1.3 , 5.7 ) • Pediatric patients (less than 18 years) ( 1.3 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplantation Zortress is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [ see Clinical Studies (14.1)] . Zortress is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. Therapeutic drug monitoring (TDM) of everolimus and cyclosporine is recommended for all patients receiving these products [ see Dosage and Administration (2.2 , 2.3)] . 1.2 Prophylaxis of Organ Rejection in Liver Transplantation Zortress is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. Zortress is to be administered no earlier than 30 days posttransplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [ s ee Warnings and Precautions (5. 5 ) , Clinical Studies (14.2) ] . TDM of everolimus and tacrolimus is recommended for all patients receiving these products [ s ee Dosage and Administration (2.3 , 2.5)] . 1.3 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 [ s ee Warnings and Precautions (5. 7 ) ] Pediatric patients (less than 18 years).
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