EVEROLIMUS tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Par Pharmaceutical, 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 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

Přehled produktů:

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

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

EVEROLIMUS- EVEROLIMUS TABLET
PAR PHARMACEUTICAL, INC.
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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