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, 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 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, 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) ]. 1.4 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.
mylan pharmaceuticals inc.
OVAL WHITE M EVR2
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16 HOW SUPPLIED/STORAGE AND HANDLING
EVEROLIMUS Tablets are available containing 2.5 mg, 5 mg, 7.5 mg or 10 mg of
EVEROLIMUS. The 2.5 mg tablets are white to slightly yellow, capsule shaped, unscored tablets debossed with M on one side of the tablet and EVR2 on the other side. They are available as follows: NDC 0378-3096-28 bottles of 28 tablets NDC 0378-3096-85 cartons of 28 tablets The 5 mg tablets are white to slightly yellow, capsule shaped, unscored tablets debossed with M on one side of the tablet and EVR5 on the other side. They are available as follows: NDC 0378-3097-28 bottles of 28 tablets NDC 0378-3097-85 cartons of 28 tablets The 7.5 mg tablets are white to slightly yellow, capsule shaped, unscored tablets debossed with M on one side of the tablet and EVR7 on the other side. They are available as follows: NDC 0378-3098-28 bottles of 28 tablets NDC 0378-3098-85 cartons of 28 tablets The 10 mg tablets are white to slightly yellow, capsule shaped, unscored tablets debossed with M on one side of the tablet and EVR10 on the other side. They are available as follows: NDC 0378-3099-28 bottles of 28 tablets NDC 0378-3099-85 cartons of 28 tablets 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. Follow special handling and disposal procedures for anti-cancer pharmaceuticals. 1
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