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Everolimus tablest 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 tablets 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 tablets 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 tablets is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. Everolimus tablets is to be administered no …

Hypersensitivity to everolimus, sirolimus, or to components of the drug product ( 4 ) 4.1 Hypersensitivity Reactions Everolimus tablets is contraindicated in patients with known hypersensitivity to everolimus, sirolimus, or to components of the drug product.

Angioedema [increased risk with concomitant angiotensin converting enzyme (ACE inhibitors)] : Monitor for symptoms and treat promptly ( 5.8 ) Delayed Wound Healing/Fluid Accumulation : Monitor symptoms; treat promptly to minimize complications ( 5.9 ) Interstitial Lung Disease (ILD)/Non-Infectious Pneumonitis : Monitor for symptoms or radiologic changes; manage by dose reduction or discontinuation until symptoms resolve; consider use of corticosteroids ( 5.10 ) Hyperlipidemia (elevations of serum cholesterol and triglycerides) : Monitor and consider anti-lipid therapy ( 5.11 ) Proteinuria (increased risk with higher trough concentrations) : Monitor urine protein ( 5.12 ) Polyoma Virus Infections (activation of latent viral infections; BK virus associated nephropathy) : Consider reducing immunosuppression ( 5.13 ) TMA/TTP/HUS (concomitant use with cyclosporine may increase risk) : Monitor for hematologic changes or symptoms ( 5.15 ) New Onset Diabetes After Transplantation : Monitor serum glucose ( 5.16 ) Male Infertility : Azoospermia or oligospermia may occur ( 5.18 , 13.1 ) Immunizations : Avoid live vaccines ( 5.19 ) Embryo-Fetal Toxicity : Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with everolimus tablets and for 8 weeks after final dose ( 5.17 , 8.1 , 8.3 ) 5.1 Management of Immunosuppression Only physicians experienced in management of systemic immunosuppressant therapy in …

8.1 Pregnancy Risk Summary Based on animal studies and the mechanism of action [see Clinical Pharmacology (12.1)], everolimus tablets can cause fetal harm when administered to a pregnant woman. There are limited case reports of everolimus tablets use in pregnant women; however, these reports are insufficient to inform a drug-associated risk of adverse developmental outcomes. Reproductive studies in animals have demonstrated that everolimus was maternally toxic in rabbits and caused embryo-fetal toxicities in rats and rabbits, at exposures near or below those achieved in human transplant patients. Advise pregnant women of the potential risk to a fetus. The background risk of major birth …