DOSAGE AND ADMINISTRATION ARIMIDEX (anastrozole generic)
OARIMIDEX (anastrozole generic) tablets for oral administration contain 1 mg of anastrozole, a nonsteroidal
aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a’, a’-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl).
DOSAGE FORMS AND STRENGTHS ARIMIDEX (anastrozole generic)
1 mg tablets
•Women of premenopausal endocrine status, including pregnant women.
• Patients with demonstrated hypersensitivity to ARIMIDEX or any excipient
WARNINGS AND PRECAUTIONS
• In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events occurred with ARIMIDEX use compared to tamoxifen use. Consider risks and benefits.)
• Decreases in bone mineral density may occur. Consider bone mineral density monitoring.
• Increases in total cholesterol may occur. Consider cholesterol monitoring.
• Tamoxifen: Do not use in combination with ARIMIDEX. No additional benefit seen over tamoxifen monotherapy.
• Estrogen-containing products: Combination use may diminish activity of ARIMIDEX.
USE IN SPECIFIC POPULATIONS
• Pediatric patients: Efficacy has not been demonstrated for pubertal boys of adolescent age with gynecomastia or girls with McCune-Albright Syndrome and progressive precocious puberty.
In the early breast cancer (ATAC) study, the most common (occurring with an incidence of >10%) side effects occurring in women taking ARIMIDEX included: hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression,
nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema and lymphedema, regardless of causality.
What should I discuss with my healthcare provider before taking anastrozole?
You should not use this medication if you are allergic to anastrozole, if you are breast-feeding a baby, or if you have not yet completed menopause. Anastrozole is not for use in men or children.
To make sure anastrozole is safe for you, tell your doctor if you have:
a history of stroke or blood clot;
severe liver disease;
high cholesterol; or
osteoporosis or low bone mineral density.
Anastrozole can decrease bone mineral density, which may increase your risk of developing osteoporosis. Your bone mineral density may need to be tested before and during treatment with anastrozole.
Although it is not likely that a postmenopausal woman would be pregnant, anastrozole could harm an unborn baby. Do not take this medicine if you are pregnant or may become pregnant. Use effective birth control if you are not past menopause, and tell your doctor right away if you become pregnant during treatment.
It is not known whether anastrozole passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using anastrozole.
You may need to take a pregnancy test before using anastrozole, to make sure you are not pregnant.