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Treatment should be discontinued at relapse [ see Clinical Studies (14. Use in Extended Adjuvant Treatment of Early Breast Cancer. In the extended adjuvant setting, the optimal treatment duration with Femara is not known. The planned duration of treatment in the study was 5 years. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration for Femara was 60 months. Seventy-one percent (71%) of patients were treated for at least 3 years and 58% of patients completed at least 4. The treatment should be discontinued at tumor relapse [see Clinical Studies (14. Use in First and Second-Line Treatment of Advanced Breast Cancer. In patients with advanced disease, treatment with Femara should continue until tumor progression is evident [see Clinical Studies (14. Use in Hepatic Impairment. No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although Femara blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of Femara in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see Warnings and Precautions (5. The recommended dose of Femara for such patients is 2. The effect of hepatic impairment on Femara exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined. Use in Renal Impairment. No dosage adjustment is required for patients with renal impairment if creatinine clearance is greater than or equal to 10 mL/min [ s ee Clinical Pharmacology (12. Pregnancy: Letrozole can cause fetal harm [see Use in Specific Populations (8, buy steroids melbourne. Known hypersensitivity to the active substance, or to any of the excipients [see Adverse Reactions (6)]. Use of Femara may cause decreases in bone mineral density (BMD). Consideration should be given to monitoring BMD. Results of a safety study to evaluate safety in the adjuvant setting comparing the effect on lumbar spine (L2-L4) BMD of adjuvant treatment with letrozole to that with tamoxifen showed at 24 months a median decrease in lumbar spine BMD of 4. Updated results from the BMD substudy (MA-17B) in the extended adjuvant setting demonstrated that at 2 years patients receiving letrozole had a median decrease from baseline of 3. The changes from baseline in lumbar spine BMD in letrozole and placebo treated groups were not significantly different [see Adverse Reactions (6)]. In the adjuvant trial (BIG 1-98) the incidence of bone fractures at any time after randomization was 14. The incidence of osteoporosis was 5.
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