EXEMESTANE tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX)

Доступно од:

Mylan Pharmaceuticals Inc.

INN (Међународно име):

EXEMESTANE

Састав:

EXEMESTANE 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1)] . Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2)]. Exemestane tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. Based on findings in animal studies and its mechanism of action, exemestane tablets can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited human data from case reports are insufficient to inform a drug-associated risk. In animal reproduction studies, administration of exemestane to pregnant rats and rabbits caused increased inc

Резиме производа:

Exemestane Tablets are available containing 25 mg of exemestane, USP. The 25 mg tablets are white, film-coated, round, unscored tablets debossed with X on one side of the tablet and M on the other side. They are available as follows: NDC 0378-5001-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

EXEMESTANE- EXEMESTANE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXEMESTANE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EXEMESTANE TABLETS.
EXEMESTANE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Exemestane tablets are an aromatase inhibitor indicated for:
•
•
DOSAGE AND ADMINISTRATION
Recommended Dose: One 25 mg tablet once daily after a meal (2.1).
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 6/2018
adjuvant treatment of postmenopausal women with estrogen-receptor
positive early breast cancer who have
received two to three years of tamoxifen and are switched to
exemestane tablets for completion of a total of five
consecutive years of adjuvant hormonal therapy (14.1).
treatment of advanced breast cancer in postmenopausal women whose
disease has progressed following tamoxifen
therapy (14.2).
Patients with a known hypersensitivity to the drug or to any of the
excipients (4).
Reductions in bone mineral density (BMD) over time are seen with
exemestane use (5.1).
Routine assessment of 25-hydroxy vitamin D levels prior to the start
of aromatase inhibitor treatment should be
performed (5.2).
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of
reproductive potential of the potential risk to a fetus
and to use effective contraception (5.6, 8.1, 8.3).
Early breast cancer: Adverse reactions occurring in ≥ 10% of
patients in any treatment group (exemestane tablets vs.
tamoxifen) were hot flushes (21.2% vs. 19.9%), fatigue (16.1% vs.
14.7%), arthralgia (14.6% vs. 8.6%), headache
(1