EVEROLIMUS tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Teva Pharmaceuticals USA, Inc.

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. Everolimus tablets are indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease. Everolimus tablets are indicated for the treatment of adult patients with progressive, well-differentiated, non-functional NET of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. Limitations of Use: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors [see Clinical Studies (14.2)] . Everolimus tablets are indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib. Everolimus tablets are indicated for the treatment of adult patient

leaflet_short:

Everolimus Tablets 2.5 mg tablets White to slightly yellow, elongated tablets with a bevelled edge and no score debossed with “TEVA” on one side and “7766” on the other side; available in:            NDC 0093-7766-24 – Carton containing 4 blister cards of 7 tablets each (28 tablets total). 5 mg tablets White to slightly yellow, elongated tablets with a bevelled edge and no score debossed with “TEVA” on one side and “7767” on the other side; available in:            NDC 0093-7767-24 – Carton containing 4 blister cards of 7 tablets each (28 tablets total). 7.5 mg tablets White to slightly yellow, elongated tablets with a bevelled edge and no score debossed with “TEVA” on one side and “7768” on the other side; available in:            NDC 0093-7768-24 – Carton containing 4 blister cards of 7 tablets each (28 tablets total). 10 mg tablets White to slightly yellow, elongated tablets with a bevelled edge and no score debossed with “TEVA” on one side and “7769” on the other side; available in:           NDC 0093-7769-24 – Carton containing 4 blister cards of 7 tablets each (28 tablets total). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in the original container, protect from light and moisture. Keep this and all drugs out of the reach of children. Follow special handling and disposal procedures for anti-cancer pharmaceuticals.1

authorization_status:

Abbreviated New Drug Application

SPC

EVEROLIMUS- EVEROLIMUS TABLET
TEVA PHARMACEUTICALS USA, INC.
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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
INDICATIONS AND USAGE
Everolimus tablets are a kinase inhibitor indicated for the treatment
of:
Postmenopausal women with advanced hormone receptor-positive,
HER2-negative breast cancer in
combination with exemestane after failure of treatment with letrozole
or anastrozole. (1.1)
Adults with progressive neuroendocrine tumors of pancreatic origin
(PNET) and adults with progressive,
well-differentiated, non-functional neuroendocrine tumors (NET) of
gastrointestinal (GI) or lung origin
that are unresectable, locally advanced or metastatic.
Limitations of Use: Everolimus tablets are not indicated for the
treatment of patients with functional
carcinoid tumors. (1.2)
Adults with advanced renal cell carcinoma (RCC) after failure of
treatment with sunitinib or sorafenib.
(1.3)
Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC),
not requiring immediate
surgery. (1.4)
Everolimus tablets are a kinase inhibitor indicated for the treatment
of adult and pediatric patients aged 1
year and older with TSC who have subependymal giant cell astrocytoma
(SEGA) that requires therapeutic
intervention but cannot be curatively resected. (1.5)
DOSAGE AND ADMINISTRATION
Modify the dose for patients with hepatic impairment or for patients
taking drugs that inhibit or induce P-
glycoprotein (P-gp) and CYP3A4. (2.1)
Breast Cancer:
10 mg orally once daily. (2.2)
NET:
10 mg orally once daily. (2.3)
RCC:
10 mg orally once daily. (2.4)
TSC-Associated Renal Angiomyolipoma:
10 mg orally once daily. (2.5)
TSC-Associated SEGA:
4.5 mg/m orally once daily; adjust dose to attain trough
concentrations of 5 to 15 ng/mL. (2.6, 2.8)
DOSAGE FORMS AND STRENGTHS
Everolimus tablets: 2.5 mg, 5 mg, 7.5 mg, and 10