Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Everolimus (UNII: 9HW64Q8G6G) (Everolimus - UNII:9HW64Q8G6G)
Biocon Pharma 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 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 but cannot be curatively resected. Everolimus are contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see Warnings and Precautions (5.3)] . Risk Summary Based on animal studies and the mechanism of action [see Clinical Pharmacology (12.1)] , everolimus tablets can cause fetal harm when administered to a pregnant woman. There are limited case reports of everolimus tablets use in pregnant women; however, these reports ar
Everolimus tablets 2.5 mg tablets: White to off white, capsule shaped, flat faced bevelled edge tablet debossed with B 2.5 on one side and plain on other side; available in: Blisters of 28 tablets ---------- NDC 70377-010-22 Bottle of 30 tablets with child resistant closure ----- NDC 70377-010-11 Each carton contains 4 blister cards of 7 tablets each 5 mg tablets: White to off white, capsule shaped, flat faced bevelled edge tablet debossed with B 5 on one side and plain on other side; available in: Blisters of 28 tablets ---------- NDC 70377-011-22 Bottle of 30 tablets with child resistant closure ----- NDC 70377-011-11 Each carton contains 4 blister cards of 7 tablets each 7.5 mg tablets: White to off white, capsule shaped, flat faced bevelled edge tablet debossed with B 7.5 on one side and plain on other side; available in: Blisters of 28 tablets ---------- NDC 70377-012-22 Bottle of 30 tablets with child resistant closure ----- NDC 70377-012-11 Each carton contains 4 blister cards of 7 tablets each 10 mg tablets: White to off white, capsule shaped, flat faced bevelled edge tablet debossed with B 10 on one side and plain on other side; available in: Blisters of 28 tablets ---------- NDC 70377-013-22 Bottle of 30 tablets with child resistant closure ----- NDC 70377-013-11 Each carton contains 4 blister cards of 7 tablets each Store 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.Follow special handling and disposal procedures for anticancer pharmaceuticals.1
Abbreviated New Drug Application
EVEROLIMUS- EVEROLIMUS TABLET BIOCON PHARMA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EVEROLIMUS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVEROLIMUS. EVEROLIMUS TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2009 RECENT MAJOR CHANGES Warnings and Precautions, Radiation Sensitization and Radiation Recall (5.12) 4/2021 INDICATIONS AND USAGE Everolimus Tablets are 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 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 Do not combine everolimus tablets and AFINITOR DISPERZ to achieve the total daily dose. (2.1) 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) 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 (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 sev Baca dokumen lengkap