Arimidex (Anastrozole)

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ARIMIDEX safely and effectively. See full prescribing information for ARIMIDEX. ARIMIDEX® (anastrozole) tablet, for oral use ... Table of Contents Table of Contents 1 INDICATIONS AND USAGE 1.1 Adjuvant Treatment - ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment - ARIMIDEX is ... 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dose - The dose of ARIMIDEX is one 1 mg tablet taken once a day. For patients with advanced breast cancer, ARIMIDEX should be continued until tumor progression. ARIMIDEX can be ... 3 DOSAGE FORMS AND STRENGTHS The tablets are white, biconvex, film-coated containing 1 mg of anastrozole. The tablets are impressed on one side with a logo consisting of a letter “A” (upper case) with an arrowhead attached to ... 4 CONTRAINDICATIONS Hypersensitivity - ARIMIDEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema ... 5 WARNINGS AND PRECAUTIONS 5.1 Ischemic Cardiovascular Events - In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with ARIMIDEX in the ATAC trial (17 ... 6 ADVERSE REACTIONS Serious adverse reactions with ARIMIDEX occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face ... 7 DRUG INTERACTIONS 7.1 Tamoxifen - Co-administration of anastrozole and tamoxifen in breast cancer patients reduced anastrozole plasma concentration by 27%. However, the co-administration of anastrozole and ... 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy - Risk Summary - Based on findings from animal studies and its mechanism of action, ARIMIDEX may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ... 10 OVERDOSAGE Clinical trials have been conducted with ARIMIDEX, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer ... 11 DESCRIPTION ARIMIDEX (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a' ... 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action - The growth of many cancers of the breast is stimulated or maintained by estrogens. In postmenopausal women, estrogens are mainly derived from the action of the ... 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - A conventional carcinogenesis study in rats at doses of 1.0 to 25 mg/kg/day (about 10 to 243 times the daily maximum recommended human ... 14 CLINICAL STUDIES 14.1 Adjuvant Treatment of Breast Cancer in Postmenopausal Women - A multicenter, double-blind trial (ATAC) randomized 9,366 postmenopausal women with operable breast cancer to adjuvant ... 16 HOW SUPPLIED/STORAGE AND HANDLING ARIMIDEX (anastrozole) Tablets, 1 mg are supplied in bottles of 30 tablets (NDC 62559-670-30). Storage - Store at controlled room temperature, 20 to 25°C (68 to 77°F) [see USP]. 17 PATIENT COUNSELING INFORMATION See FDA approved patient labeling (Patient Information). Hypersensitivity Reactions - Inform patients of the possibility of serious allergic reactions with swelling of the face, lips, tongue ... Patient Information ARIMIDEX® A-rim-eh-dex - (anastrozole) tablets - What is the most important information I should know about ARIMIDEX? ARIMIDEX may cause serious side effects including: • heart disease. Women ... PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Arimidex® anastrozole tablets - 1 mg - NDC 62559-670-30 - Rx only - 30 Tablets INGREDIENTS AND APPEARANCE Product Information