EVEROLIMUS tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Ascend Laboratories, LLC

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Everolimus tablets are 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 tablets are to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. Therapeutic drug monitoring (TDM) of everolimus tablets and cyclosporine is recommended for all patients receiving these products. [see Dosage and Administration (2.2, 2.3) ] Everolimus tablets are indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. Everolimus tablets are 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) ]. Therapeutic drug monitoring (TDM) of everolimus tablets and tacrolimus is recommended for all patients receiving these products [see Dosage and Adm

Přehled produktů:

Everolimus Tablets are packed in child-resistant blisters and bottles. 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. 

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

EVEROLIMUS - EVEROLIMUS TABLET
ASCEND LABORATORIES, LLC
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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 TABLETS. (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
TABLETS 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)
INDICATIONS AND USAGE
• Everolimus tablets are a 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 has 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 dos