Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G)
Par Pharmaceutical, Inc.
ORAL
PRESCRIPTION DRUG
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. 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 renal angiomyolipoma and TSC, not requiring immediate surgery. 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 bu
Everolimus Tablets 2.5 mg tablets White to slightly yellow, capsule shaped tablets with a beveled edge and no score, engraved with “P” on one side and “119” on the other side; available in: Blisters of 28 tablets……………………………………………………………………NDC 49884-119-91 Each carton contains 4 blister cards of 7 tablets each 5 mg tablets White to slightly yellow, capsule shaped tablets with a beveled edge and no score, engraved with “P” on one side and “125” on the other side; available in: Blisters of 28 tablets……………………………………………………………………NDC 49884-125-91 Each carton contains 4 blister cards of 7 tablets each 7.5 mg tablets White to slightly yellow, capsule shaped tablets with a beveled edge and no score, engraved with “P” on one side and “127” on the other side; available in: Blisters of 28 tablets……………………………………………………………………NDC 49884-127-91 Each carton contains 4 blister cards of 7 tablets each 10 mg tablets White to slightly yellow, capsule shaped tablets with a beveled edge and no score, engraved with “P” on one side and “128” on the other side; available in: Blisters of 28 tablets……………………………………………………………………NDC 49884-128-91 Each carton contains 4 blister cards of 7 tablets each Store Everolimus Tablets at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°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 anticancer pharmaceuticals.1
Abbreviated New Drug Application
EVEROLIMUS- EVEROLIMUS TABLET PAR 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 RECENT MAJOR CHANGES Warnings and Precautions, Radiation Sensitization and Radiation Recall (5.12) 04/2021 INDICATIONS AND USAGE Everolimus Tablets 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) Limitations of Use: Everolimus Tablets 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) 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) Breast Cancer: 10 mg orally once daily. (2.2) PNET: 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 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 eve সম্পূর্ণ নথি পড়ুন