País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX)
Bryant Ranch Prepack
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 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 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 cause
Exemestane tablets are White colored, round, biconvex, film-coated tablets debossed with "X" on one side and "1" on other side. Each tablet contains 25 mg of exemestane. Exemestane tablets are packaged in HDPE bottles with a child-resistant screw cap, supplied in bottles of 30 tablets. 30-tablet HDPE bottle NDC 63629-2056-1. Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
EXEMESTANE- EXEMESTANE TABLET, FILM COATED BRYANT RANCH PREPACK ---------- 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 tablets 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 tablets and tamoxifen (6% vs. 5%). Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were exemestane tablets 1.6%, tamoxifen 0.6%. Incidence of cardiac f Leer el documento completo