Anastrozole Tablets, USP - Uses, Dosage, Side Effects, and Warnings

Anastrozole tablets are an aromatase inhibitor indicated for adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women, first-line treatment of hormone receptor-positive or unknown locally advanced or metastatic breast cancer in postmenopausal women, and treatment of advanced breast cancer following tamoxifen therapy. It is administered as a 1 mg tablet once daily.

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer; first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer; treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.

Anastrozole

One 1 mg tablet taken once daily. For advanced breast cancer, continue until tumor progression. Can be taken with or without food. Optimal duration for adjuvant treatment is unknown, but administered for five years in the ATAC trial. No dosage adjustment necessary for patients with renal impairment or elderly patients. No dose changes recommended for mild-to-moderate hepatic impairment. Has not been studied in severe hepatic impairment.

Hypersensitivity to anastrozole or any excipients, including reactions such as anaphylaxis, angioedema, and urticaria.

In postmenopausal women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events occurred compared to tamoxifen; consider risk vs benefit. Decreases in bone mineral density may occur; consider bone mineral density monitoring. Increases in total cholesterol may occur; consider cholesterol monitoring. May cause fetal harm; advise effective contraception during therapy and for at least 3 weeks after last dose.

Common adverse reactions (≥10%) include hot flashes, asthenia, arthritis, pain, arthralgia, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, peripheral edema, cough increased, dyspnea, pharyngitis, and lymphedema. Serious adverse reactions include skin lesions, allergic reactions (e.g., anaphylaxis, angioedema), and liver function abnormalities.

Anastrozole may cause fetal harm. Advise pregnant women and females of reproductive potential about potential fetal risk. Females of reproductive potential should use effective contraception during treatment and for at least 3 weeks after the last dose.