everolimus 0.25 mg
1 INDICATIONS AND USAGE Everolimus 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 : 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 Everolimus is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunologic risk receiving a kidney transplant [see Clinical Studies ( 14.1 )] . 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 [see Dosage and Administration ( 2.2 , 2.3 )] . 1.2 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 [see Warnings and Precautions ( 5.5 ), Clinical Studies ( 14.2 )] . TDM of everolimus and tacrolimus is recommended for all patients receiving these products [see Dosage and Administration ( 2.3 , 2.5 )] . 1.3 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 [see Warnings and Precautions ( 5.7 )]. • Pediatric patients (less than 18 years).
hikma pharmaceuticals usa inc.
ROUND WHITE 54 414
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16 HOW SUPPLIED/STORAGE AND HANDLING
EVEROLIMUS Tablets 0.25 mg tablets are supplied as white to off white, round standard convex tablets, plain on one side and “54” over “414” debossed on the other side. NDC 0054-0470-21: Bottles of 60 Tablets 0.5 mg tablets are supplied as white to off white, round standard convex tablets, plain on one side and “54” over “761” debossed on the other side. NDC 0054-0471-21: Bottles of 60 Tablets 0.75 mg tablets are supplied as white to off white, round standard convex tablets, plain on one side and “54” over “044” debossed on the other side. NDC 0054-0472-21: Bottles of 60 Tablets 1 mg are supplied as white to off white, round, flat faced beveled edge tablets, plain on one side and “54” over “206” debossed on the other side. NDC 0054-0604-21: Bottles of 60 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.
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