everolimus tablet
1 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 ) 1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer 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. 1.2 Neuroendocrine Tumors (NET) 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 )] . 1.3 Renal Cell Carcinoma (RCC) Everolimus tablets are indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib. 1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma Everolimus tablets are indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery. 1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) Everolimus tablets are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected.
teva pharmaceuticals usa, inc.
OVAL WHITE Teva 7768
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everolimus tablet
teva pharmaceuticals usa, inc.
everolimus tablet
teva pharmaceuticals usa, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
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
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