EVEROLIMUS tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G)

Dostupné s:

Mylan Pharmaceuticals Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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, 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)]. 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 is contraindicated in patients with clinically significant hypersen

Přehled produktů:

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

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

EVEROLIMUS- EVEROLIMUS TABLET
MYLAN PHARMACEUTICALS 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
INDICATIONS AND USAGE
Everolimus tablets are a kinase inhibitor indicated for the treatment
of:
•
•
•
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)
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:
•
NET:
•
TSC-Associated Renal Angiomyolipoma:
•
TSC-Associated SEGA:
•
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
•
•
•
•
•
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)
®
10 mg orally once daily. (2.2)
10 mg orally once daily. (2.3)
10 mg orally once daily. (2.5)
4.5 mg/m orally once daily; adjus