EVEROLIMUS tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G)

Available from:

Natco Pharma Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Everolimus is indicated for the prophylaxis of organ rejection in adult patients at low-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)] . 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 post-transplant 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)]. The safety and efficacy of everolimus has not been estab

Product summary:

Everolimus tablets are packed in child-resistant blisters. Table 11. Description of Everolimus Tablets Each strength is available in boxes of 60 tablets (6 blister strips of 10 tablets each). Storage  Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].  Protect from light and moisture. 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EVEROLIMUS - EVEROLIMUS TABLET
NATCO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVEROLIMUS TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
EVEROLIMUS TABLETS.
EVEROLIMUS TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS, KIDNEY GRAFT THROMBOSIS;
NEPHROTOXICITY; AND MORTALITY IN HEART TRANSPLANTATION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF
TRANSPLANT PATIENTS SHOULD USE EVEROLIMUS (5.1)
INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF
MALIGNANCIES
MAY RESULT FROM IMMUNOSUPPRESSION (5.2, 5.3)
INCREASED INCIDENCE OF KIDNEY GRAFT THROMBOSIS (5.4)
REDUCED DOSES OF CYCLOSPORINE ARE REQUIRED FOR USE IN COMBINATION WITH
EVEROLIMUS
IN ORDER TO REDUCE NEPHROTOXICITY (2.4, 2.5, 5.6, 12.7, 12.8)
INCREASED MORTALITY IN A HEART TRANSPLANT CLINICAL TRIAL. USE IN HEART
TRANSPLANTATION IS
NOT RECOMMENDED (5.7)
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.17) 1/2018
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 post-transplant.
Use in combination with tacrolimus
(reduced doses) and corticosteroids. (1.2, 5.5)
Limitations of Use (1.3)
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)
DOSAGE AND ADMINISTRATION
Kidney Transplantation: starting oral dose of 0.75 mg twice daily as
soon as possible after
transplantation (2.1)
Liver Transplantation: starting oral dose of