EXEMESTANE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Eirgen Pharma Ltd

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Exemestane is 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 for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies ( 14.1 )] . Exemestane is 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. Risk Summary Based on findings in animal studies and its mechanism of action, exemestane 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, administratio

Ürün özeti:

Exemestane tablets are white to off-white, round compound cup tablet with “25” on one side and plain on the reverse. Exemestane tablets are packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets. NDC 47781-108-30               HDPE bottle of 30 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

EXEMESTANE- EXEMESTANE TABLET
EIRGEN PHARMA LTD
----------
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:
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).
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
Patients with a known hypersensitivity to the drug or to any of the
excipients ( 4).
WARNINGS AND PRECAUTIONS
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).
ADVERSE REACTIONS
Early breast cancer: Adverse reactions occurring in ≥10% of patients
in any treatment group (exemestane vs.
tamoxifen) were hot flushes (21.2% vs. 19.9%), fatigue (16.1% vs.
14.7%), arthralgia (14.6% vs. 8.6%), headache
(13.1% vs. 10.8%), insomnia (12.4% vs. 8.9%), and increased sweating
(11.8% vs. 10.4%). Discontinuation rates due to
AEs were similar between exemestane and tamoxifen (6.3% vs. 5.1%).
Incidences of cardiac ischemic events
(myocardial infarction, angina, and myocardial ischemia) were
exemestane 1.6%, tamoxifen 0.6%. Incidence of cardiac
fail