Australia - English - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - raloxifene hydrochloride -

Australia - English - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - raloxifene hydrochloride -

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

avpak - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride (hcl) tablets, usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see  clinical studies (14.1,  14.2)] . raloxifene hcl tablets, usp are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hcl tablets, usp 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 hcl tablets, usp should be based upon an individual assessment of the benefits and risks. raloxifene hcl tablets, usp does not eliminate the risk of breast cancer. patients should have breast exams and mammograms before starting raloxifene hcl tablets, usp and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene hcl tablets, usp. important limitations of use for breast cancer risk reduction - there are no data available regarding the effect of raloxifene hcl tablets, usp on invasive breast cancer incidence in women with inherited mutations (brca1, brca2) to be able to make specific recommendations on the effectiveness of raloxifene hcl tablets, usp. - raloxifene hcl tablets, usp are not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence. - raloxifene hcl tablets, usp are not indicated for the reduction in the risk of noninvasive breast cancer. raloxifene hcl, usp is 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 hcl, usp is contraindicated in pregnancy, in women who may become pregnant and in nursing mothers [see  use in specific populations (8.1,  8.3)] . raloxifene hcl, usp may cause fetal harm when administered to a pregnant woman. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. in rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m 2 ) and hydrocephaly was observed in fetuses at doses ≥10 mg/kg (≥4 times the human dose based on surface area, mg/m 2 ). in rat studies, retardation of fetal development and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses ≥1 mg/kg (≥0.2 times the human dose based on surface area, mg/m 2 ). treatment of rats at doses of 0.1 to 10 mg/kg (0.02 to 1.6 times the human dose based on surface area, mg/m 2 ) during gestation and lactation 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, raloxifene disrupted parturition, which resulted in maternal and progeny death and morbidity. effects in adult offspring (4 months of age) included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed. pregnancy category x. raloxifene hcl should not be used in women who are or may become pregnant [see contraindications (4.2)] . raloxifene hcl should not be used by lactating women [see contraindications (4.2)] . it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when raloxifene is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. of the total number of patients in placebo-controlled clinical studies of raloxifene hcl, 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 hcl 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 hcl should be used with caution in patients with hepatic impairment [see warnings and precautions (5.5) and clinical pharmacology (12.3)] . to report suspected adverse reactions, contact avkare, inc. at 1-855-361-3993; email drugsafety@avkare.com; or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

United States - English - 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)] .

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

bryant ranch prepack - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride tablets, usp 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

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

a-s medication solutions - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride tablets, usp 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

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

aphena pharma solutions - tennessee, llc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride tablets, usp is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . raloxifene hydrochloride tablets, usp is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride tablets, usp is 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

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

major pharmaceuticals - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride tablets, usp is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . raloxifene hydrochloride tablets, usp is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride tablets, usp is 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 (

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

bryant ranch prepack - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride tablets, usp 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

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

remedyrepack inc. - 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 d