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Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions/Side Effects Drug Interactions Use In Specific Populations Overdosage Description Clinical Pharmacology Nonclinical Toxicology Clinical Studies How Supplied/Storage and Handling Patient Counseling Information. Indications and Usage for Aromasin. Adjuvant Treatment of Postmenopausal Women. Aromasin is 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 Aromasin for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14. Advanced Breast Cancer in Postmenopausal Women. Aromasin is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14, anabolic steroids with least side effects. Aromasin Dosage and Administration. The recommended dose of Aromasin in early and advanced breast cancer is one 25 mg tablet once daily after a meal. Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure, For patients receiving Aromasin with a strong CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of Aromasin is 50 mg once daily after a meal [see Drug Interactions (7) and Clinical Pharmacology (12. Dosage Forms and Strengths. Aromasin Tablets are round, biconvex, and off-white to slightly gray. Each tablet contains 25 mg of exemestane. The tablets are printed on one side with the number “7663” in black. Aromasin is contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. Reductions in Bone Mineral Density (BMD) Reductions in bone mineral density (BMD) over time are seen with exemestane use. Table 1 describes changes in BMD from baseline to 24 months in patients receiving exemestane compared to patients receiving tamoxifen (IES) or placebo (027). Concomitant use of bisphosphonates, vitamin D supplementation, and calcium was not allowed. Percent Change in BMD from Baseline to 24 months, Exemestane vs. Control 1 IES 027 BMD Exemestane N=29 Tamoxifen 1 N=38 Exemestane N=59 Placebo 1 N=65 Lumbar spine (%) -3. During adjuvant treatment with exemestane, women with osteoporosis or at risk of osteoporosis should have their bone mineral density formally assessed by bone densitometry at the commencement of treatment. Monitor patients for bone mineral density loss and treat as appropriate. Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed, due to the high prevalence of vitamin D deficiency in women with early breast cancer (EBC). Women with vitamin D deficiency should receive supplementation with vitamin D. Administration with Estrogen-Containing Agents. Aromasin should not be coadministered with estrogen-containing agents as these could interfere with its pharmacologic action.
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A separate carcinogenicity study was conducted in rats at the doses of 30, 100, and 315 mg/kg/day exemestane (gavage) for 92 weeks in males and 2 years in females. No evidence of carcinogenic activity up to the highest dose tested of 315 mg/kg/day was observed in females. The male rat study was inconclusive since it was terminated prematurely at Week 92. At the highest dose, plasma AUC (0’24hr) levels in male (1418 ‘ 287 ng. Exemestane was not mutagenic in vitro in bacteria (Ames test) or mammalian cells (V79 Chinese hamster lung cells). Exemestane was clastogenic in human lymphocytes in vitro without metabolic activation but was not clastogenic in vivo (micronucleus assay in mouse bone marrow). Exemestane did not increase unscheduled DNA synthesis in rat hepatocytes when tested in vitro. In a pilot reproductive study in rats, male rats were treated with doses of 125’1000 mg/kg/day exemestane, beginning 63 days prior to and during cohabitation. Untreated female rats showed reduced fertility when mated to males treated with ?500 mg/kg/day exemestane (?200 times the recommended human dose on a mg/m 2 basis). In a separate study, exemestane was given to female rats at 4’100 mg/kg/day beginning 14 days prior to mating and through day 15 or 20 of gestation. Exemestane increased the placental weights at ?4 mg/kg/day (?1. Exemestane showed no effects on ovarian function, mating behavior, and conception rate in rats given doses up to 20 mg/kg/day (approximately 8 times the recommended human dose on a mg/m 2 basis); however, decreases in mean litter size and fetal body weight, along with delayed ossification were evidenced at 20 mg/kg/day., anabolic steroids with least side effects. 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