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1 Indications And Usage Sirolimus Is An Mtor Inhibitor Immunosuppressant Indicated For The Prophylaxis Of Organ Rejection In Patients Aged ≥13 Years Receiving Renal Transplants: – Patients At Low- To Moderate-Immunologic Risk: Use Initially With Cyclosporine (Csa) And Corticosteroids. Csa Withdrawal Is Recommended 2–4 Months After Transplantation ( 1.1 ). – Patients At High-Immunologic Risk: Use In Combination With Csa And Corticosteroids For The First 12 Months Following Transplantation ( 1.1 ). Safety And Efficacy Of Csa Withdrawal Has Not Been Established In High Risk Patients ( 1.1 , 1.2 , 14.3 ). Sirolimus Is An Mtor Inhibitor Indicated For The Treatment Of Patients With Lymphangioleiomyomatosis ( 1.3 ). 1.1 Prophylaxis Of Organ Rejection In Renal Transplantation Sirolimus Is Indicated For The Prophylaxis Of Organ Rejection In Patients Aged 13 Years Or Older Receiving Renal Transplants. In Patients At Low- To Moderate-Immunologic Risk, It Is Recommended That Sirolimus Be Used Initially In A Regimen With Cyclosporine And Corticosteroids; Cyclosporine Should Be Withdrawn 2 To 4 Months After Transplantation [ See Dosage And Administration (2.2) ]. In Patients At High-Immunologic Risk (Defined As Black Recipients And/or Repeat Renal Transplant Recipients Who Lost A Previous Allograft For Immunologic Reason And/or Patients With High Panel-Reactive Antibodies [Pra; Peak Pra Level >80%]), It Is Recommended That Sirolimus Be Used In Combination With Cyclosporine And Corticosteroids For The First Year Following Transplantation [ See Dosage And Administration (2.3) , Clinical Studies (14.3) ]. 1.2 Limitations Of Use In Renal Transplantation Cyclosporine Withdrawal Has Not Been Studied In Patients With Banff Grade 3 Acute Rejection Or Vascular Rejection Prior To Cyclosporine Withdrawal, Those Who Are Dialysis-Dependent, Those With Serum Creatinine >4.5 Mg/dl, Black Patients, Patients Of Multi-Organ Transplants, Secondary Transplants, Or Those With High Levels Of Panel-Reactive Antibodies [ See Clinical Studies (14.2) ]. In Patients At High-Immunologic Risk, The Safety And Efficacy Of Sirolimus Used In Combination With Cyclosporine And Corticosteroids Has Not Been Studied Beyond One Year; Therefore After The First 12 Months Following Transplantation, Any Adjustments To The Immunosuppressive Regimen Should Be Considered On The Basis Of The Clinical Status Of The Patient [ See Clinical Studies (14.3) ]. In Pediatric Patients, The Safety And Efficacy Of Sirolimus Have Not Been Established In Patients <13 Years Old, Or In Pediatric (<18 Years) Renal Transplant Patients Considered At High-Immunologic Risk [ See Adverse Reactions (6.5) , Clinical Studies (14.6) ]. The Safety And Efficacy Of De Novo Use Of Sirolimus Without Cyclosporine Have Not Been Established In Renal Transplant Patients [ See Warnings And Precautions (5.12) ]. The Safety And Efficacy Of Conversion From Calcineurin Inhibitors To Sirolimus In Maintenance Renal Transplant Patients Have Not Been Established [ See Clinical Studies (14.4) ]. 1.3 Treatment Of Patients With Lymphangioleiomyomatosis Sirolimus Is Indicated For The Treatment Of Patients With Lymphangioleiomyomatosis (Lam).
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