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

teva pharmaceuticals usa, inc. - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole 2.5 mg - letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see clinical studies (14.2, 14.3) ]. letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see clinical studies (14.4, 14.5)] . - pregnancy: letrozole can cause fetal harm [see use in specific populations (8.1) ]. - known hy

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

dr. reddy's laboratories limited - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole 2.5 mg - letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. . letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see clinical studies (14.2, 14.3) ]. letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see clinical studies (14.4, 14.5) ]. letrozole tablets may cause fetal harm when administered to a pregnant woman and the clinicl ben

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

avkare - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole 2.5 mg - letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [ see clinical studies (14.2, 14.3) ]. letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [ see clinical studies (14.4, 14.5) ]. - pregnancy: letrozole can cause fetal harm [ see use in specific populations (8.1) ]. - known hypersensitivity to the active substance, or to any of the excipients [ see adverse reactions (6) ]. risk summary based on postmarketing reports, findings from animal studies and the mechanism of action, letrozole can cause fetal harm and is contraindicated for use in pregnant women. in postmarketing reports, use of letrozole during pregnancy resulted in cases of spontaneous abortions and congenital birth defects; however, the data are insufficient to inform a drug-associated risk [ see contraindications (4), warnings and precautions (5.6), adverse reactions (6.2), and clinical pharmacology (12.1) ]. in animal reproduction studies, administration of letrozole to pregnant animals during organogenesis resulted in increased post-implantation pregnancy loss and resorption, fewer live fetuses, and fetal malformation affecting the renal and skeletal systems in rats and rabbits at doses approximately 0.1 times the daily maximum recommended human dose (mrhd) on a mg/m 2 basis (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in a fertility and early embryonic development toxicity study in female rats, oral administration of letrozole starting 2 weeks before mating until pregnancy day 6 resulted in an increase in pre-implantation loss at doses ≥ 0.003 mg/kg/day (approximately 0.01 times the maximum recommended human dose on a mg/m 2 basis). in an embryo-fetal developmental toxicity study in rats, daily administration of oral letrozole during the period of organogenesis at doses ≥ 0.003 mg/kg (approximately 0.01 time the maximum recommended human dose on a mg/m 2 basis) resulted in embryo-fetal toxicity including intrauterine mortality, increased resorptions and postimplantation loss, decreased numbers of live fetuses and fetal anomalies including absence and shortening of renal papilla, dilation of ureter, edema and incomplete ossification of frontal skull and metatarsals. letrozole was teratogenic to rats at a dose of 0.03 mg/kg (approximately 0.01 times the maximum recommended human dose on a mg/m 2 basis) and caused fetal domed head and cervical/centrum vertebral fusion. in the embryo-fetal development toxicity study in rabbits, daily administration of oral letrozole during the period of organogenesis at doses ≥ 0.002 mg/kg (approximately 0.01 times the maximum recommended human dose on a mg/m 2 basis) resulted in embryo-fetal toxicity including intrauterine mortality, increased resorption, increased postimplantation loss and decreased numbers of live fetuses. fetal anomalies included incomplete ossification of the skull, sternebrae, and fore- and hind legs. risk summary it is not known if letrozole is present in human milk. there are no data on the effects of letrozole on the breastfed infant or milk production. exposure of lactating rats to letrozole was associated with impaired reproductive performance of the male offspring ( see data ). because of the potential for serious adverse reactions in breastfed infants from letrozole, advise lactating women not to breastfeed while taking letrozole and for at least 3 weeks after the last dose. data animal data in a postnatal developmental toxicity study in lactating rats, letrozole was administered orally at doses of 1, 0.003, 0.03 or 0.3 mg/kg/day on day 0 through day 20 of lactation. the reproductive performance of the male offspring was impaired at letrozole dose as low as 0.003 mg/kg/day (approximately 0.01 times the maximum recommended human dose on a mg/m 2 basis), as reflected by decreased mating and pregnancy ratios. there were no effects on the reproductive performance of female offspring. pregnancy testing based on animal studies, letrozole can cause fetal harm when administered to a pregnant woman [ see use in specific populations (8.1) ]. females of reproductive potential should have a pregnancy test prior to starting treatment with letrozole. contraception females based on animal studies, letrozole can cause fetal harm when administered to a pregnant woman [ see use in specific populations (8.1) ]. advise females of reproductive potential to use effective contraception during treatment with letrozole and for at least 3 weeks after the last dose. infertility females based on studies in female animals, letrozole may impair fertility in females of reproductive potential [ see nonclinical toxicology (13.1) ]. males based on studies in male animals, letrozole may impair fertility in males of reproductive potential [ see nonclinical toxicology (13.1) ]. the safety and effectiveness in pediatric patients have not been established. letrozole administration to young (postnatal day 7) rats for 12 weeks duration at 0.003, 0.03, 0.3 mg/kg/day by oral gavage resulted in adverse skeletal/growth effects (bone maturation, bone mineral density) and neuroendocrine and reproductive developmental perturbations of the hypothalamic-pituitary axis. administration of 0.3 mg/kg/day resulted in auc values that were similar to the auc in adult patients receiving the recommended dose of 2.5 mg/day. decreased fertility was accompanied by hypertrophy of the hypophysis and testicular changes that included degeneration of the seminiferous tubular epithelium and atrophy of the female reproductive tract. young rats in this study were allowed to recover following discontinuation of letrozole treatment for 42 days. histopathological changes were not reversible at clinically relevant exposures. the median age of patients in all studies of first-line and second-line treatment of metastatic breast cancer was 64 to 65 years. about 1/3 of the patients were greater than or equal to 70 years old. in the first-line study, patients greater than or equal to 70 years of age experienced longer time to tumor progression and higher response rates than patients less than 70. for the extended adjuvant setting (ma-17), more than 5,100 postmenopausal women were enrolled in the clinical study. in total, 41% of patients were aged 65 years or older at enrollment, while 12% were 75 or older. in the extended adjuvant setting, no overall differences in safety or efficacy were observed between these older patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. in the adjuvant setting (big 1-98), more than 8,000 postmenopausal women were enrolled in the clinical study. in total, 36% of patients were aged 65 years or older at enrollment, while 12% were 75 or older. more adverse reactions were generally reported in elderly patients irrespective of study treatment allocation. however, in comparison to tamoxifen, no overall differences with regards to the safety and efficacy profiles were observed between elderly patients and younger patients.

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

rebel distributors corp - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole 2.5 mg - letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see clinical studies (14.2, 14.3) ]. letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see clinical studies (14.4, 14.5) ]. letrozole tablets may cause fetal harm when administered to a pregnant woman and the clinical bene

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

physicians total care, inc. - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole 2.5 mg - enter section text here letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see clinical studies (14.2, 14.3)] . letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see clinical studies (14.4, 14.5)] . letrozole tablets may cause fetal harm when administered to a pregna

Israel - English - Ministry of Health

dexcel ltd, israel - letrozole - film coated tablets - letrozole 2.5 mg - letrozole - letrozole - letrozole - dexcel tablets is indicated for first-line treatment in postmenopausal women with hormone receptor positive or in whome hormone receptor status cannot be determined locally advanced or metastatic breast cancer. letrozole - dexcel is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy. adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

Israel - English - Ministry of Health

teva israel ltd - letrozole - tablets - letrozole 2.5 mg - letrozole - letrozole teva tablets is indicated for first-line treatment in postmenopausal women with hormone receptor positive or in whom hormone receptor status cannot be determined, locally advanced or metastatic breast cancer: letrozole teva is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy. adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

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

arab pharmaceutical manufacturing co. psc ltd - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole 2.5 mg - letrozole tablets, usp are indicated for the adjuvant treatment of postmenopausal women with hormonereceptor positive early breast cancer. letrozole tablets, usp are indicated for the extended adjuvant treatment of early breast cancer inpostmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [s e e c lini c al studi e s ( 14.2 , 14.3 ) ] . letrozole tablets, usp are indicated for first-line treatment of postmenopausal women with hormonereceptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets usp, are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [s e e   c lini c al studi e s   ( 14.4 , 14.5 ) ] . letrozole tablets may cause fetal harm when adminis

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

accord healthcare, inc. - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole 2.5 mg - letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.  letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see clinical studies ( 14.2, 14.3)] . letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy  [see clinical studies ( 14.4, 14.5)]. - pregnancy: letrozole can cause fetal harm [see use in specific populations ( 8.1)] . pregnancy: letrozole can cause fetal harm [see use in specific populations ( 8.1)] . - known hypersensitivity to the active substance, or to any of the excipients [see adverse reactions ( 6)] . known hypersensitivity to the active substance, or to any of the excipients [see adverse reactions ( 6)] . risk summary  based on postmarketing reports, findings from animal studies and the mechanism of action, letrozole can cause fetal harm and is contraindicated for use in pregnant women. in post-marketing reports, use of letrozole during pregnancy resulted in cases of spontaneous abortions and congenital birth defects; however, the data are insufficient to inform a drug-associated risk [see contraindications ( 4), warnings and precautions ( 5.6), adverse reactions ( 6.2) and clinical pharmacology ( 12.1)]. in animal reproduction studies, administration of letrozole to pregnant animals during organogenesis resulted in increased post-implantation pregnancy loss and resorption, fewer live fetuses, and fetal malformation affecting the renal and skeletal systems in rats and rabbits at doses approximately 0.1 times the daily maximum recommended human dose (mrhd) on a mg/m 2 basis (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in a fertility and early embryonic development toxicity study in female rats, oral administration of letrozole starting 2 weeks before mating until pregnancy day 6 resulted in an increase in pre-implantation loss at doses ≥ 0.003 mg/kg/day (approximately 0.01 times the maximum recommended human dose on a mg/m 2 basis). in an embryo-fetal developmental toxicity study in rats, daily administration of oral letrozole during the period of organogenesis at doses ≥ 0.003 mg/kg (approximately 0.01 time the maximum recommended human dose on a mg/m 2 basis) resulted in embryo-fetal toxicity including intrauterine mortality, increased resorptions and postimplantation loss, decreased numbers of live fetuses and fetal anomalies including absence and shortening of renal papilla, dilation of ureter, edema and incomplete ossification of frontal skull and metatarsals. letrozole was teratogenic to rats at a dose of 0.03 mg/kg (approximately 0.01 times the maximum recommended human dose on a mg/m 2 basis) and caused fetal domed head and cervical/centrum vertebral fusion. in the embryo-fetal development toxicity study in rabbits, daily administration of oral letrozole during the period of organogenesis at doses ≥ 0.002 mg/kg (approximately 0.01 times the maximum recommended human dose on a mg/m 2 basis) resulted in embryo-fetal toxicity including intrauterine mortality, increased resorption, increased postimplantation loss and decreased numbers of live fetuses. fetal anomalies included incomplete ossification of the skull, sternebrae, and fore- and hind legs. risk summary it is not known if letrozole is present in human milk. there are no data on the effects of letrozole on the breastfed infant or milk production. exposure of lactating rats to letrozole was associated with impaired reproductive performance of the male offspring (see data). because of the potential for serious adverse reactions in breastfed infants from letrozole tablets, advise lactating women not to breastfeed while taking letrozole tablets and for at least 3 weeks after the last dose. data animal data in a postnatal developmental toxicity study in lactating rats, letrozole was administered orally at doses of 1, 0.003, 0.03 or 0.3 mg/kg/day on day 0 through day 20 of lactation. the reproductive performance of the male offspring was impaired at letrozole dose as low as 0.003 mg/kg/day (approximately 0.01 times the maximum recommended human dose on a mg/m 2 basis), as reflected by decreased mating and pregnancy ratios. there were no effects on the reproductive performance of female offspring. pregnancy testing based on animal studies, letrozole can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)]. females of reproductive potential should have a pregnancy test prior to starting treatment with letrozole. contraception females based on animal studies, letrozole tablets can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)]. . advise females of reproductive potential to use effective contraception during treatment with letrozole tablets and for at least 3 weeks after the last dose. infertility females based on studies in female animals, letrozole tablets may impair fertility in females of reproductive potential [see nonclinical toxicology ( 13.1)]. males based on studies in male animals, letrozole tablets may impair fertility in males of reproductive potential [see nonclinical toxicology ( 13.1)]. the safety and effectiveness in pediatric patients have not been established. letrozole administration to young (postnatal day 7) rats for 12 weeks duration at 0.003, 0.03, 0.3 mg/kg/day by oral gavage resulted in adverse skeletal/growth effects (bone maturation, bone mineral density) and neuroendocrine and reproductive developmental perturbations of the hypothalamic-pituitary axis. administration of 0.3 mg/kg/day resulted in auc values that were similar to the auc in adult patients receiving the recommended dose of 2.5 mg/day. decreased fertility was accompanied by hypertrophy of the hypophysis and testicular changes that included degeneration of the seminiferous tubular epithelium and atrophy of the female reproductive tract. young rats in this study were allowed to recover following discontinuation of letrozole treatment for 42 days. histopathological changes were not reversible at clinically relevant exposures. the median age of patients in all studies of first-line and second-line treatment of metastatic breast cancer was 64 to 65 years. about 1/3 of the patients were greater than or equal to 70 years old. in the first-line study, patients greater than or equal to 70 years of age experienced longer time to tumor progression and higher response rates than patients less than 70. for the extended adjuvant setting (ma-17), more than 5,100 postmenopausal women were enrolled in the clinical study. in total, 41% of patients were aged 65 years or older at enrollment, while 12% were 75 or older. in the extended adjuvant setting, no overall differences in safety or efficacy were observed between these older patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. in the adjuvant setting (big 1-98), more than 8,000 postmenopausal women were enrolled in the clinical study. in total, 36 % of patients were aged 65 years or older at enrollment, while 12% were 75 or older. more adverse reactions were generally reported in elderly patients irrespective of study treatment allocation. however, in comparison to tamoxifen, no overall differences with regards to the safety and efficacy profiles were observed between elderly patients and younger patients.

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

breckenridge pharmaceutical, inc. - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole 2.5 mg - letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see clinical studies (14.2, 14.3)] . letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see clinical studies (14.4, 14.5)]. - pregnancy: letrozole can cause fetal harm [see use in specific populations (8.1)] . - known hyper