Index of drugs

Treatment of advanced breast cancer in postmenopausal women who have been found to have a hormone receptor in the tumor. Supplementary treatment of early breast cancer in postmenopausal women who have been found to have a hormone receptor in the tumor. Supplementary treatment of early breast cancer in postmenopausal women who have been found to have a hormone receptor in the tumor after 2-3 years of adjuvant tamoxifen.

1 tabl powl. contains 1 mg of anastrozole. The preparation contains lactose.

A strong and selective non-steroidal aromatase inhibitor involved in the conversion of androstenedione to oestrone in peripheral tissues (subsequently transformed into estradiol). It has been shown that in post-menopausal women, the use of anastrozole 1 mg daily causes suppression of oestradiol production by over 80%. Anastrozole has no progestagen, androgenic and estrogenic activity. Administration at a dose of up to 10 mg per day does not affect the secretion of cortisol and aldosterone both without and after stimulation of excretion by ACTH (therefore, during treatment, corticosteroid supplementation is not necessary). Following oral administration, anastrozole is rapidly absorbed from the gastrointestinal tract. The maximum concentration in the blood usually occurs within 2 hours of admission (fasting). The presence of food reduces the rate of absorption to a small extent, but does not affect the extent of absorption. The drug binds to 40% of plasma proteins. In postmenopausal women, the drug is extensively metabolised, less than 10% of the dose is excreted in the urine in unchanged form within 72 hours of admission. Anastrozole is metabolized by N-dealkylation, hydroxylation and glucuronidation. Metabolites are mainly excreted in the urine. T_0,5 is 40-50 h.

Hypersensitivity to the active substance or any of the excipients. Pregnancy and breastfeeding.

The preparation should not be used in pre-menopausal women. In the case of doubts concerning the hormonal status of patients, hormone levels should be measured: LH, FSH and estradiol in order to confirm menopause. There is no data on the concomitant use of the preparation with LHRH analogues. The simultaneous use of Tamoxifen or estrogen-containing medicines with anastrozole should be avoided because it reduces its pharmacological effect. Due to the risk of a decrease in bone mineral density and bone fractures, women with diagnosed osteoporosis or the risk of osteoporosis should have a bone densitometry test prior to treatment. This test should be repeated regularly during treatment. If there are indications, treatment or prevention of osteoporosis should be started and regular monitoring of their effectiveness. The use of specialized drugs, e.g. bisphosphonates, should be considered. Caution should be exercised when treating patients with moderate or severe hepatic impairment (no study); treatment should be based on benefit and risk assessment. Caution should be exercised when using the preparation in patients with severe renal impairment (no study). The preparation is not recommended for use in children and adolescents due to insufficient data on safety and efficacy in this group of patients. The preparation should not be used in boys with growth hormone deficiency in combination with growth hormone therapy (efficacy has not been demonstrated and safety has not been established). It must not be used in girls who are deficient in growth hormone as a supplement to growth hormone therapy. Long-term safety data for children and adolescents are not available. The product contains lactose - should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

The drug is contraindicated in pregnant women and during breastfeeding.

Very common: headache, hot flushes, nausea, rash, joint pain and stiffness, arthritis, osteoporosis, weakness.Common: anorexia, hypercholesterolemia, drowsiness, carpal tunnel syndrome (most cases in patients with predisposition to this disease), diarrhea, vomiting, increased alkaline phosphatase, ALT and AST in the serum, hair thinning (alopecia), allergic reactions, bone pain, muscle pain, vaginal dryness, vaginal bleeding (usually in patients with advanced breast cancer, during the first few weeks after changing therapy with hormonal therapy to anastrozole treatment, if bleeding is prolonged, a change in treatment should be considered). Uncommon: hypercalcaemia (with or without increasing parathyroid hormone), increased GGT and serum bilirubin, hepatitis, urticaria, and a crackling finger. Rare: erythema multiforme, anaphylactoid reactions, cutaneous vasculitis, including cases of Henoch-Schonlein purpura. Very rare: Stevens-Johnson syndrome, angioneurotic edema.

Orally. Adult patients, including the elderly: 1 mg once a day. In postmenopausal patients with early breast cancer who have been found to have a hormone receptor in their tumors, hormone replacement therapy is recommended for 5 years. No dose adjustment is required in patients with mild or moderate renal impairment or with mild hepatic insufficiency.