Everolimusdrug info

1 INDICATIONS & USAGE Everolimus tablets are a 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

Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids Limitations of Use: Safety and efficacy have not been established in the following:

Kidney transplant patients at high immunologic risk

Recipients of transplanted organs other than kidney or liver

Pediatric patients (less than 18 years)

1.1 Prophylaxis of

Organ Rejection in Kidney Transplantation Everolimus tablets are indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunologic risk receiving a kidney transplant. Everolimus tablets are to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. Therapeutic drug monitoring (TDM) of everolimus tablets and cyclosporine is recommended for all patients receiving these products.

1.2 Prophylaxis of

Organ Rejection in Liver Transplantation Everolimus tablets are indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. Everolimus tablets are to be administered no earlier than 30 days posttransplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids. TDM of everolimus tablets and tacrolimus is recommended for all patients receiving these products.

1.3 Limitations of

Use The safety and efficacy of everolimus tablets 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 (less than18 years).