United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - anastrozole (unii: 2z07myw1az) (anastrozole - unii:2z07myw1az) - 1.1 adjuvant treatment anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 first-line treatment anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. 1.3 second-line treatment anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. patients with er-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. 4.1 pregnancy and premenopausal women anastrozole may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. anastrozole is contraindicated in women who are or may become pregnant. there are no adequate and well-controlled studies in pregnant women using an

Malta - English - Malta Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - anastrozole - film-coated tablet - anastrozole 1 mg - endocrine therapy

United States - English - NLM (National Library of Medicine)

stason pharmaceuticals, inc - anastrozole (unii: 2z07myw1az) (anastrozole - unii:2z07myw1az) - anastrozole is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. anastrozole is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. anastrozole is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. patients with er-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole. anastrozole may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. anastrozole is contraindicated in women who are or may become pregnant. there are no adequate and well-controlled studies in pregnant women using anastrozole. if anastrozole is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus or potential risk for loss of the pregnancy. [see use in specific populations ( 8.1)] anastrozole 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, and urticaria. [see adverse reactions ( 6.2)] pregnancy category x [see contraindications ( 4.1)] anastrozole may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. anastrozole is contraindicated in women who are or may become pregnant. in animal studies, anastrozole caused pregnancy failure, increased pregnancy loss, and signs of delayed fetal development. there are no studies of anastrozole use in pregnant women. if anastrozole is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus and potential risk for pregnancy loss. in animal reproduction studies, pregnant rats and rabbits received anastrozole during organogenesis at doses equal to or greater than 1 (rats) and 1/3 (rabbits) the recommended human dose on a mg/m 2 basis. in both species, anastrozole crossed the placenta, and there was increased pregnancy loss (increased pre-and/or post-implantation loss, increased resorption, and decreased numbers of live fetuses). in rats, these effects were dose related, and placental weights were significantly increased. fetotoxicity, including delayed fetal development (i.e., incomplete ossification and depressed fetal body weights), occurred in rats at anastrozole doses that produced peak plasma levels 19 times higher than serum levels in humans at the therapeutic dose (auco-24hr 9 times higher). in rabbits, anastrozole caused pregnancy failure at doses equal to or greater than 16 times the recommended human dose on a mg/m 2 basis. [see animal toxicology and/or pharmacology ( 13.2)] it is not known if anastrozole is excreted in human milk. because many drugs are excreted in human milk and because of the tumorigenicity shown for anastrozole in animal studies, or the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the efficacy of anastrozole tablets in the treatment of pubertal gynecomastia in adolescent boys and in the treatment of precocious puberty in girls with mccune-albright syndrome has not been demonstrated. labeling describing clinical trials and pharmacokinetic studies of anastrozole in pubertal boys of adolescent age with gynecomastia and in girls with mccune-albright syndrome and progressive precocious puberty is approved for astrazeneca pharmaceuticals lp’s anastrozole®. however, due to astrazeneca pharmaceuticals lp’s marketing exclusivity rights, a description of those trials and studies is not approved for this anastrozole product. in studies 0030 and 0027 about 50% of patients were 65 or older. patients ≥ 65 years of age had moderately better tumor response and time to tumor progression than patients < 65 years of age regardless of randomized treatment. in studies 0004 and 0005 50% of patients were 65 or older. response rates and time to progression were similar for the over 65 and younger patients. in the atac study 45% of patients were 65 years of age or older. the efficacy of anastrozole compared to tamoxifen in patients who were 65 years or older (n=1413 for anastrozole and n=1410 for tamoxifen, the hazard ratio for disease-free survival was 0.93 (95% ci: 0.80, 1.08)) was less than efficacy observed in patients who were less than 65 years of age (n=1712 for anastrozole and n=1706 for tamoxifen, the hazard ratio for disease-free survival was 0.79 (95% ci: 0.67, 0.94)). the pharmacokinetics of anastrozole are not affected by age. since only about 10% of anastrozole is excreted unchanged in the urine, the renal impairment does not influence the total body clearance. dosage adjustment in patients with renal impairment is not necessary [see dosage and administration ( 2.1) and clinical pharmacology ( 12.3)]. the plasma anastrozole concentrations in the subjects with hepatic cirrhosis were within the range of concentrations seen in normal subjects across all clinical trials. therefore, dosage adjustment is also not necessary in patients with stable hepatic cirrhosis. anastrozole has not been studied in patients with severe hepatic impairment. [see dosage and administration ( 2.2) and clinical pharmacology ( 12.3)]

United States - English - NLM (National Library of Medicine)

direct_rx - anastrozole (unii: 2z07myw1az) (anastrozole - unii:2z07myw1az) - 1.1 adjuvant treatment anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 first-line treatment anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. 1.3 second-line treatment anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. patients with er-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. hypersensitivity anastrozole 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, and urticaria [see adverse reactions ( 6.2)]. 8.1 pregnancy risk summary based on findings from animal studies and its mechanism of a

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - anastrozole - film-coated tablet - 1 milligram(s) - aromatase inhibitors; anastrozole

Ireland - English - HPRA (Health Products Regulatory Authority)

synthon bv - anastrozole - film-coated tablet - 1 milligram(s) - aromatase inhibitors; anastrozole

Ireland - English - HPRA (Health Products Regulatory Authority)

bluefish pharmaceuticals ab - anastrozole - film-coated tablet - 1 milligram(s) - aromatase inhibitors; anastrozole

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - anastrozole - oral tablet - 1mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - anastrozole - oral tablet - 1mg

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - anastrozole - film-coated tablet - 1 milligram(s) - aromatase inhibitors; anastrozole