Anastrozole is indicated for:

• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• First-line treatment of postmenopausal women with hormone receptor-positive or unknown receptor status in locally advanced or metastatic breast cancer
• Second-line treatment of advanced breast cancer in postmenopausal women who have shown disease progression after tamoxifen therapy

Patients with estrogen receptor (ER)-negative tumors or those who did not respond to previous tamoxifen therapy are less likely to benefit from Anastrozole.

Anastrozole is a non-steroidal aromatase inhibitor. In many breast cancers, tumor growth is driven by estrogen. In postmenopausal women, estrogen is mainly produced by the conversion of adrenal androgens into estrone and estradiol through the action of the aromatase enzyme. Anastrozole selectively inhibits this enzyme, reducing estrogen production in peripheral tissues and tumor sites, thereby slowing or stopping cancer growth.

The dose of Anastrozole is one tablet 1 mg taken once a day. For patients with advanced breast cancer, Anastrozole should be continued until tumor progression. For adjuvant treatment of early breast cancer in postmenonausal women, the optimal duration of therapy is unknown.

Patients with Hepatic Impairment: No changes in dose are recommended for patients with mild-to-moderate hepatic impairment. Anastrozole has not been studied in patients with severe hepatic impairment.

Patients with Renal Impairment: No changes in dose are necessary for patients with renal impairment.

Pediatric Use: The safety and efficacy of Anastrozole in pediatric patients have not been established.

Geriatric Use: The pharmacokinetics of Anastrozole are not affected by age

Co-administration of Anastrozole with tamoxifen reduces Anastrozole plasma levels by about 27%, therefore concurrent use is not recommended. Estrogen-containing therapies should also be avoided as they can counteract its therapeutic effect. Studies indicate that Anastrozole does not significantly affect the pharmacokinetics or anticoagulant activity of warfarin. Additionally, it is unlikely to cause clinically relevant drug interactions through cytochrome P450 inhibition.

Anastrozole is contraindicated in pregnant women and premenopausal women, as it may cause fetal harm and provides no clinical benefit in this group. It should not be used in women who are pregnant or may become pregnant. It is also contraindicated in patients with known hypersensitivity to Anastrozole or any of its components.

Serious adverse reactions are rare (less than 1 in 10,000 patients) and may include severe skin reactions (lesions, ulcers, blisters), allergic reactions with swelling of the face, lips, tongue, or throat, and liver function abnormalities including hepatitis. Common side effects (more than 10%) include hot flashes, weakness, joint pain, arthritis, hypertension, depression, nausea, vomiting, skin rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, peripheral edema, cough, breathing difficulty, sore throat, and lymphedema.

Pregnancy Category X. Anastrozole should not be used during pregnancy due to the risk of fetal harm. It is not known whether the drug is excreted in breast milk. A decision should be made to either discontinue breastfeeding or stop the medication, depending on its importance to the mother.

• Cardiovascular risk: Patients with pre-existing ischemic heart disease may have an increased risk of cardiovascular events
• Bone health: Anastrozole may reduce bone mineral density, increasing the risk of fractures
• Cholesterol: Elevated cholesterol levels have been reported during treatment

Careful risk-benefit assessment is required in patients with cardiovascular disease or osteoporosis.

Clinical studies have shown that single doses up to 60 mg and daily doses up to 10 mg are generally well tolerated. No specific life-threatening dose has been established. There is no specific antidote; treatment is symptomatic and supportive.

Hormonal anticancer (aromatase inhibitor).

Store below 30°C, protected from light and moisture. Keep out of reach of children.