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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, testo-cypmax 250 mg injectable steroids $41.00 testosterone cypionate. 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. 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. In the extended adjuvant trial (MA-17), the incidence of bone fractures at any time after randomization was 13. The incidence of new osteoporosis was 14. Consideration should be given to monitoring serum cholesterol. In the adjuvant trial (BIG 1-98), hypercholesterolemia was reported in 52. Grade 3-4 hypercholesterolemia was reported in 0. Also in the adjuvant setting, an increase of greater than or equal to 1. Subjects with cirrhosis and severe hepatic impairment who were dosed with 2.
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Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adjuvant Treatment of Early Breast Cancer. In study, BIG 1-98, the median treatment duration of adjuvant treatment was 60 months and the median duration of follow-up for safety was 96 months for patients receiving Femara and tamoxifen. Certain adverse reactions were prospectively specified for analysis (see Table 1), based on the known pharmacologic properties and side effect profiles of the two drugs. Adverse reactions were analyzed irrespective of whether a symptom was present or absent at baseline. Most adverse reactions reported (approximately 75% of patients who reported AEs) were Grade 1 or Grade 2 applying the Common Toxicity Criteria (CTC) Version 2. Table 1 describes adverse reactions (Grades 1-4 and Grades 3-4) irrespective of relationship to study treatment in the adjuvant trial for the monotherapy arms analysis (safety population). Table 1: Patients With Adverse Reactions (CTC Grades 1-4) in the Adjuvant Study ‘ Monotherapy Arms Analysis (Median Follow-up 96 Months; Median Treatment 60 Months) Grades 1-4 Grades 3-4 Femara Tamoxifen Femara Tamoxifen Adverse R eaction s N = 2448 N = 2447 N = 2448 N = 2447 n (%) n (%) n (%) n (%) Patients with any adverse reaction 2309 (94. TIA = Transient ischemic attack, testo-cypmax 250 mg injectable steroids $41.00 testosterone cypionate. Note: Cardiovascular events (including cerebrovascular and thromboembolic events), skeletal and urogenital/endometrial events and second primary malignancies were collected life -long. All of these events were assumed to be of CTC Grade 3 to 5 and were not individually graded. When considering all grades during study treatment, a higher incidence of events was seen for Femara regarding fractures (10. A higher incidence was seen for tamoxifen regarding thromboembolic events (2. At a median follow-up of 96 months, a higher incidence of events was seen for Femara (14. A higher incidence was seen for tamoxifen compared to Femara regarding thromboembolic events (4. Bone Study : Results of a safety trial in 263 postmenopausal women with resected receptor positive early breast cancer 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. In another postapproval randomized, multicenter, open label, study of letrozole vs anastrozole in the adjuvant treatment of postmenopausal women with hormone receptor and node positive breast cancer (FACE, NCT00248170), the median duration of treatment was 60 months for both treatment arms. 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