Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
Exemestane (UNII: NY22HMQ4BX) (Exemestane - UNII:NY22HMQ4BX)
Upsher-Smith Laboratories, Inc.
Exemestane
Exemestane 25 mg
ORAL
PRESCRIPTION DRUG
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 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 increased inciden
Exemestane tablets, USP are a white to off-white, round, biconvex, bevel-edged, film-coated tablet engraved with 'US' on one face and plain on the other. Exemestane tablets are packaged in HDPE bottles with a child-resistant screw cap. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
EXEMESTANE- EXEMESTANE TABLET UPSHER-SMITH LABORATORIES, 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: 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: exemestane 0.4%, tamoxifen Lire le document complet