AFINITOR- everolimus tablet AFINITOR DISPERZ- everolimus tablet, for suspension

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Novartis Pharmaceuticals Corporation

ИНН (Международная Имя):

EVEROLIMUS

состав:

EVEROLIMUS 5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

AFINITOR® is 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. AFINITOR is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease. AFINITOR is 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: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors [see Clinical Studies (14.2)] . AFINITOR is indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib. AFINITOR is indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery.

Обзор продуктов:

AFINITOR 2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51 Each carton contains 4 blister cards of 7 tablets each 5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51 Each carton contains 4 blister cards of 7 tablets each 7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51 Each carton contains 4 blister cards of 7 tablets each 10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51 Each carton contains 4 blister cards of 7 tablets each AFINITOR DISPERZ 2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51 Each carton contains 4 blister cards of 7 tablets each 3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51 Each carton contains 4 blister cards of 7 tablets each 5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51 Each carton contains 4 blister cards of 7 tablets each Store 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 Авторизация:

New Drug Application

Характеристики продукта

AFINITOR- EVEROLIMUS TABLET
AFINITOR DISPERZ- EVEROLIMUS TABLET, FOR SUSPENSION
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AFINITOR/AFINITOR
DISPERZ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AFINITOR/AFINITOR
DISPERZ.
AFINITOR (EVEROLIMUS) TABLETS, FOR ORAL USE
AFINITOR DISPERZ (EVEROLIMUS TABLETS FOR ORAL SUSPENSION)
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Warnings and Precautions, Radiation Sensitization and Radiation Recall
(5.12)
4/2021
INDICATIONS AND USAGE
AFINITOR is 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: AFINITOR is 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)
AFINITOR and AFINITOR DISPERZ 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)
AFINITOR DISPERZ is a kinase inhibitor indicated for the adjunctive
treatment of adult and pediatric
patients aged 2 years and older with TSC-associated partial-onset
seizures. (1.6)
DOSAGE AND ADMINISTRATION
Do not combine AFINITOR and AFINITOR DISPERZ to achieve the total
daily dose. (2.1)
Modify the dose for patients w