EXEMESTANE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Florida Pharmaceutical Products, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 is 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, administration of exemestane to pregnant rats and rabbits caused incre

Produktsammanfattning:

Exemestane Tablets, USP are white or almost white round film-coated tablets, debossed with 111 on one side. Each tablet contains 25 mg of exemestane, USP. Exemestane Tablets, USP are packaged in HDPE bottles with a child-resistant screw cap, supplied in packs as follows. Bottle of 30 NDC 71921-190-33 Bottle of 90 NDC 71921-190-09 Store at 25°C (77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

EXEMESTANE- EXEMESTANE TABLET, FILM COATED
FLORIDA PHARMACEUTICAL PRODUCTS, LLC
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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 is 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 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% vs. 20%), fatigue
(16% vs. 15%), arthralgia (15% vs.
9%), headache (13% vs. 11%), insomnia (12% vs. 9%), and increased
sweating (12% vs. 10%).
Discontinuation rates due to AEs were similar between exemestane and
tamoxifen (6% vs. 5%).
Incidences of cardiac ischemic events (myocardial infarction, angina,
and myocardial ischemia) were
exemestane 1.6%, tamoxifen 0.6%. Incidence of cardiac failure:
exemesta