What is everolimus used for?

Indications and Usage, quoted from the label by Breckenridge Pharmaceutical, Inc. (ANDA205432). Cross-references to other label sections are left out.

Prophylaxis of Organ Rejection in Kidney Transplantation

Everolimus is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunologic risk receiving a kidney transplant. Everolimus 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.

Prophylaxis of Organ Rejection in Liver Transplantation

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

Limitations of Use

The safety and efficacy of everolimus 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 than 18 years).

Source: DailyMed label, set id c7bb6ba1-9a7f-43f5-b058-ef26d4b59221, version 9, effective July 6, 2026. NDC 51991-379, one of 62 listings for this product.

Indications and Usage, quoted from the label by Biocon Pharma Inc. (ANDA217216). Cross-references to other label sections are left out.

Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)

Everolimus tablets for oral suspension are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected.

Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures

Everolimus tablets for oral suspension is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.

Source: DailyMed label, set id 5b809dfe-c076-07c5-207e-178c3f0d32d3, version 6, effective June 30, 2026. NDC 70377-090, one of 12 listings for this product.