EVEROLIMUS tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

Everolimus (UNII: 9HW64Q8G6G) (Everolimus - UNII:9HW64Q8G6G)

Доступна з:

Breckenridge Pharmaceutical, Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 patients with

Огляд продуктів:

Everolimus Tablets 2.5 mg tablets White to off-white coloured, oval, flat shaped tablets and no score, debossed with 'EVR' on one side and '2.5' on the other side; available in: 5 mg tablets White to off-white coloured, oval, flat shaped tablets and no score, debossed with 'EVR' on one side and '5' on the other side; available in: 7.5 mg tablets White to off-white coloured, oval, flat shaped tablets and no score, debossed with 'EVR' on one side and '7.5' on the other side; available in: 10 mg tablets White to off-white coloured, oval, flat shaped tablets and no score, debossed with 'EVR' on one side and 'NAT' on the other side; available in: Store Everolimus Tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). See USP Controlled Room Temperature. Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anti-cancer pharmaceuticals.1

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

EVEROLIMUS- EVEROLIMUS TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
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 kinase inhibitors 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
Do not combine everolimus tablets and everolimus tablets for oral
suspension to achieve the total daily
dose. (2.1)
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
co