EVEROLIMUS tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

Everolimus (UNII: 9HW64Q8G6G) (Everolimus - UNII:9HW64Q8G6G)

Sẵn có từ:

Biocon Pharma Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

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