EVEROLIMUS tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Natco Pharma Limited

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 wi

Обзор продуктов:

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: Blisters of 28 tablets.........................NDC 63850-0058-2 (63850-0058-1) Each carton contains 4 blister cards of 7 tablets each Bottles of 30 tablets......................... NDC 63850-0058-4 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: Blisters of 28 tablets.........................NDC 63850-0059-2 (63850-0059-1) Each carton contains 4 blister cards of 7 tablets each Bottles of 30 tablets......................... NDC 63850-0059-4 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: Blisters of 28 tablets.........................NDC 63850-0060-2 (63850-0060-1) Each carton contains 4 blister cards of 7 tablets each Bottles of 30 tablets......................... NDC 63850-0060-4 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: Blisters of 28 tablets………………NDC 63850-0061-2 (63850-0061-1) Each carton contains 4 blister cards of 7 tablets each Bottles of 30 tablets......................... NDC 63850-0061-4 Store Everolimus Tablets at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F). See USP Controlled Room Temperature. Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals.1

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

EVEROLIMUS - EVEROLIMUS TABLET
NATCO PHARMA LIMITED
----------
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:
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
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)
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 5-15 ng/mL. (2.6, 2.8)
DOSAGE FORMS AND STRENGTHS
Everolimus Tablets: 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets with no
score (3)
CONTRAINDICATIONS
Clinically significant hypersensitivity to everolimus or to other
rapamycin derivatives. (4)
WARNINGS AND PRECAUTIONS
Non-Infectious Pneumonitis: Monitor for clinical symptoms or
radiological changes. Withhold or
permanently discontinue based on severity. (2.9, 5.1)
Infections: Monitor for signs and symptoms of infection. Withhold or
permanently discontinue based on
severity. (2.9, 5.2)
Severe Hypersensitivity Reactions: Permanently discontinue for
clinically significant hypersensitivity.
(5.3)
Angioedema: Patients taking concomitant angiotensin-converting-enzyme
(ACE) inhibitors may be at
increased risk for angioed