Združene države Amerike - angleščina - NLM (National Library of Medicine)

a-s medication solutions - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tamoxifen 20 mg - tamoxifen citrate tablets, usp are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. tamoxifen citrate tablets, usp are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets, usp are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen therapy is likely to be beneficial. tamoxifen reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen therapy for breast cancer. in women with dcis, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see boxed warning at the beginning of the label). the decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy. current data from clinical trials support 5 years of adjuvant tamoxifen therapy for patients with breast cancer. tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. this effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. twenty-five percent of the participants received drug for 5 years. the longer-term effects are not known. in this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see boxed warning at the beginning of the label). tamoxifen citrate tablets are indicated only for high-risk women. “high risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥1.67%, as calculated by the gail model. examples of combinations of factors predicting a 5-year risk ≥1.67% are: age 35 or older and any of the following combination of factors: - one first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or - at least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or - lcis age 40 or older and any of the following combination of factors: - one first degree relative with a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 or older, and age at menarche 11 or younger; or - at least 2 first degree relatives with a history of breast cancer, and age at first live birth 19 or younger; or - one first degree relative with a history of breast cancer, and a personal history of a breast biopsy showing atypical hyperplasia. age 45 or older and any of the following combination of factors: - at least 2 first degree relatives with a history of breast cancer and age at first live birth 24 or younger; or - one first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, age at menarche 11 or less and age at first live birth 20 or more. age 50 or older and any of the following combination of factors: - at least 2 first degree relatives with a history of breast cancer; or - history of 1 breast biopsy showing atypical hyperplasia, and age at first live birth 30 or older and age at menarche 11 or less; or - history of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 or more. age 55 or older and any of the following combination of factors: - one first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, and age at menarche 11 or less; or - history of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 or older. age 60 or older and: - five-year predicted risk of breast cancer ≥1.67%, as calculated by the gail model. for women whose risk factors are not described in the above examples, the gail model is necessary to estimate absolute breast cancer risk. health care professionals can obtain a gail model risk assessment tool by dialing 1-888-838-2872. there are insufficient data available regarding the effect of tamoxifen on breast cancer incidence in women with inherited mutations (brca1, brca2) to be able to make specific recommendations on the effectiveness of tamoxifen citrate in these patients. after an assessment of the risk of developing breast cancer, the decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate therapy. in the nsabp p-1 trial, tamoxifen treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk (see table 3 in clinical pharmacology ). tamoxifen citrate tablets are contraindicated in patients with known hypersensitivity to the drug or any of its ingredients. tamoxifen citrate tablets are contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep-vein thrombosis or pulmonary embolus.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - tamoxifen citrate, quantity: 30.34 mg (equivalent: tamoxifen, qty 20 mg) - tablet - excipient ingredients: lactose monohydrate; maize starch; magnesium stearate; brilliant scarlet 4r; povidone - treatment of breast cancer tamoxifen lupin is indicated for the treatment of breast cancer.,primary reduction of breast cancer risk tamoxifen lupin is indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).

Združene države Amerike - angleščina - NLM (National Library of Medicine)

northstar rx llc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)] . twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. healthcare professionals can obtain a gail model risk assessment tool by dialing 1-800-545-5979. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty. after an assessment of the risk of developing breast cancer, the decision regarding therapy with raloxifene hydrochloride tablets should be based upon an individual assessment of the benefits and risks. raloxifene hydrochloride tablets does not eliminate the risk of breast cancer. patients should have breast exams and mammograms before starting raloxifene hydrochloride tablets and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene hydrochloride tablets. important limitations of use for breast cancer risk reduction - there are no data available regarding the effect of raloxifene hydrochloride tablets on invasive breast cancer incidence in women with inherited mutations (brca1, brca2) to be able to make specific recommendations on the effectiveness of raloxifene hydrochloride tablets. - raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence. - raloxifene hydrochloride tablets are not indicated for the reduction in the risk of noninvasive breast cancer. raloxifene hydrochloride tablets are contraindicated in women with active or past history of venous thromboembolism (vte), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see warnings and precautions (5.1)] . raloxifene hydrochloride is contraindicated for use in pregnancy, as it may cause fetal harm [see use in specific populations (8.1)] . risk summary raloxifene hydrochloride is contraindicated for use in pregnant women, and is not indicated for use in females of reproductive potential. based on mechanism of action, raloxifene hydrochloride may block the important functions that estrogen has during all stages of pregnancy [see clinical pharmacology (12.1)] . limited data with raloxifene hydrochloride use in pregnant women are insufficient to inform any drug associated risks for births defects or miscarriage. in rabbits and rats dosed during organogenesis or during gestation and lactation, raloxifene hydrochloride produced multiple adverse reproductive and developmental effects, including abortion; fetal anomalies; and delayed or disrupted parturition leading to maternal and neonatal mortality, at doses less than or similar to the maximum recommended human dose (based on human body surface area comparison). data animal data in the developmental and reproductive toxicity studies conducted with raloxifene hydrochloride, numerous adverse effects were observed in multiple animal species. in rabbits dosed during organogenesis, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m2 ). in rats dosed during organogenesis, retardation of fetal growth and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses ≥1 mg/kg (≥0.2 times the human dose based on surface area, mg/m2 ). treatment of rats during gestation and lactation with doses of 0.1 to 10 mg/kg (0.02 to 1.6 times the human dose based on surface area, mg/m2 ) produced effects that included delayed and disrupted parturition, decreased neonatal survival and altered physical development, sex- and age-specific reductions in growth and changes in pituitary hormone content, and decreased lymphoid compartment size in offspring. at 10 mg/kg, the disruption of parturition resulted in maternal and progeny morbidity and death. effects in adult offspring (4 months of age) included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed. risk summary raloxifene hydrochloride is not indicated for use in females of reproductive potential. there is no information on the presence of raloxifene in human milk, the effects on the breastfed child, or the effects on milk production. however, based on mechanism of action, raloxifene hydrochloride may block the important functions that estrogen has in mammary tissue during lactation [see clinical pharmacology (12.1)] . safety and effectiveness in pediatric patients have not been established. of the total number of patients in placebo-controlled clinical studies of raloxifene hydrochloride, 61% were 65 and over, while 15.5% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, 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. based on clinical trials, there is no need for dose adjustment for geriatric patients [see clinical pharmacology (12.3)] . raloxifene hydrochloride should be used with caution in patients with moderate or severe renal impairment [see warnings and precautions (5.8) and clinical pharmacology (12.3)] . raloxifene hydrochloride should be used with caution in patients with hepatic impairment [see warnings and precautions (5.5) and clinical pharmacology (12.3)] .

Združene države Amerike - angleščina - NLM (National Library of Medicine)

aurobindo pharma limited - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - metastatic breast cancer: tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablets therapy. adjuvant treatment of breast cancer: tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progester

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: povidone; magnesium stearate; citric acid monohydrate; macrogol 400; polysorbate 80; titanium dioxide; hypromellose; microcrystalline cellulose; crospovidone - raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: hypromellose; crospovidone; macrogol 400; microcrystalline cellulose; magnesium stearate; titanium dioxide; povidone; citric acid monohydrate; polysorbate 80 - raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

bryant ranch prepack - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)] . twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥ 1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. healthcare professionals can obtain a gail model risk assessment tool by dialing 1-800-545-5979. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty. after an assessment of the risk of developing breast cancer, the decision regarding therapy with raloxifene hydrochloride tablets should be based upon an individual assessment of the benefits and risks. raloxifene hydrochloride tablets does not eliminate the risk of breast cancer. patients should have breast exams and mammograms before starting raloxifene hydrochloride tablets and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene hydrochloride tablets. important limitations of use for breast cancer risk reduction - there are no data available regarding the effect of raloxifene hydrochloride tablets on invasive breast cancer incidence in women with inherited mutations (brca1, brca2) to be able to make specific recommendations on the effectiveness of raloxifene hydrochloride tablets. - raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence. - raloxifene hydrochloride tablets are not indicated for the reduction in the risk of noninvasive breast cancer. raloxifene hydrochloride tablets are contraindicated in women with active or past history of venous thromboembolism (vte), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see warnings and precautions (5.1)] . raloxifene hydrochloride is contraindicated for use in pregnancy, as it may cause fetal harm [see use in specific populations (8.1)] . risk summary raloxifene hydrochloride is contraindicated for use in pregnant women, and is not indicated for use in females of reproductive potential. based on mechanism of action, raloxifene hydrochloride may block the important functions that estrogen has during all stages of pregnancy [see clinical pharmacology (12.1)] . limited data with raloxifene hydrochloride use in pregnant women are insufficient to inform any drug associated risks for births defects or miscarriage. in rabbits and rats dosed during organogenesis or during gestation and lactation, raloxifene hydrochloride produced multiple adverse reproductive and developmental effects, including abortion; fetal anomalies; and delayed or disrupted parturition leading to maternal and neonatal mortality, at doses less than or similar to the maximum recommended human dose (based on human body surface area comparison). data animal data in the developmental and reproductive toxicity studies conducted with raloxifene hydrochloride, numerous adverse effects were observed in multiple animal species. in rabbits dosed during organogenesis, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m2 ). in rats dosed during organogenesis, retardation of fetal growth and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses ≥1 mg/kg (≥0.2 times the human dose based on surface area, mg/m2 ). treatment of rats during gestation and lactation with doses of 0.1 to 10 mg/kg (0.02 to 1.6 times the human dose based on surface area, mg/m2 ) produced effects that included delayed and disrupted parturition, decreased neonatal survival and altered physical development, sex- and age-specific reductions in growth and changes in pituitary hormone content, and decreased lymphoid compartment size in offspring. at 10 mg/kg, the disruption of parturition resulted in maternal and progeny morbidity and death. effects in adult offspring (4 months of age) included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed. risk summary raloxifene hydrochloride is not indicated for use in females of reproductive potential. there is no information on the presence of raloxifene in human milk, the effects on the breastfed child, or the effects on milk production. however, based on mechanism of action, raloxifene hydrochloride may block the important functions that estrogen has in mammary tissue during lactation [see clinical pharmacology (12.1)] . safety and effectiveness in pediatric patients have not been established. of the total number of patients in placebo-controlled clinical studies of raloxifene hydrochloride, 61% were 65 and over, while 15.5% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, 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. based on clinical trials, there is no need for dose adjustment for geriatric patients [see clinical pharmacology (12.3)] . raloxifene hydrochloride should be used with caution in patients with moderate or severe renal impairment [see warnings and precautions (5.8) and clinical pharmacology (12.3)] . raloxifene hydrochloride should be used with caution in patients with hepatic impairment [see warnings and precautions (5.5) and clinical pharmacology (12.3)] .

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; poloxamer; calcium hydrogen phosphate dihydrate; citric acid monohydrate; sodium starch glycollate; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000 - raloxifene gh is proposed to be used for:,1. the prevention and treatment of osteoprosis in post-menopausal women,2. the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis,3. the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer,high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

Izrael - angleščina - Ministry of Health

teva israel ltd - tamoxifen as citrate - tablets - tamoxifen as citrate 20 mg - tamoxifen - tamoxifen - for the palliative treatment of breast cancer generally in post menopausal women, either alone or in combination with other modalities.

Velika Britanija - angleščina - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - tamoxifen citrate - oral tablet - 20mg