Generic Name and Formulations:
Letrozole 2.5mg; tabs.
Novartis Pharmaceuticals Corp
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Indications for FEMARA:
In postmenopausal women: Adjuvant treatment of hormone receptor positive early breast cancer; Extended adjuvant treatment of early breast cancer after 5 years of adjuvant tamoxifen therapy; First-line treatment of hormone receptor positive or unknown, locally advanced or metastatic breast cancer; Treatment of advanced breast cancer with disease progression following antiestrogen therapy.
2.5mg once daily. Adjuvant or extended adjuvant therapy: discontinue at tumor relapse; see full labeling. Advanced breast cancer: continue until tumor progression is evident. Severe hepatic impairment or cirrhosis: 2.5mg every other day.
Monitor bone mineral density, serum cholesterol. Severe renal or hepatic impairment. Embryo-fetal toxicity; exclude pregnancy prior to initiation. Use effective contraception during and for ≥3wks after last dose. Nursing mothers: not recommended (during and for ≥3wks after last dose).
Pain (bone, musculoskeletal, and others), hot flashes, arthralgia, flushing, asthenia, edema, headache, dizziness, hypercholesterolemia, sweating increased, GI upset, fatigue, somnolence, dyspnea, cough, insomnia, hypertension, anorexia, weight changes; thromboembolic or cardio- or cerebrovascular events (rare).
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