Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - bazedoxifene acetate; estrogens conjugated - tablets modified release - bazedoxifene acetate 20 mg; estrogens conjugated 0.45 mg - conjugated estrogens and bazedoxifene - treatment of the following conditions in women with a uterus:• treatment of moderate to severe vasomotor symptoms associated with menopause• prevention of postmenopausal osteoporosis

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), bazedoxifene acetate (unii: j70472ud3d) (bazedoxifene - unii:q16tt9c5bk) - estrogens, conjugated 0.45 mg - duavee is indicated in women with a uterus for: duavee is contraindicated in women with any of the following conditions: risk summary duavee is contraindicated for use in pregnant women and is not indicated for use in females of reproductive potential [see contraindications (4), warnings and precautions (5.15)]. conjugated estrogens (ce) there are no data with the use of conjugated estrogens in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital and non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives before conception or during early pregnancy. bazedoxifene there are no available data on bazedoxifene use in pregnant women to inform a drug associated risk of adverse developmental outcomes. animal studies have shown that oral bazedoxifene administered during the period of organogenesis to pregnant rats or rabbits at 0.3 and 2 times, respectively, the exposure at the maximum recommended dose, can cause fetal harm [see data]. based on mechanism of action, bazedoxifene may block the important functions that estrogen has during all stages of pregnancy [see clinical pharmacology (12.1)] . data animal data bazedoxifene administration of bazedoxifene to rats at maternally toxic dosages ≥1 mg/kg/day (≥ 0.3 times the human area under the curve (auc) at the 20 mg dose) resulted in reduced numbers of live fetuses and/or reductions in fetal body weights. no fetal developmental anomalies were observed. in studies conducted with pregnant rabbits treated with bazedoxifene, abortion and an increased incidence of heart (ventricular septal defect) and skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) anomalies in the fetuses were present at maternally toxic dosages of ≥ 0.5 mg/kg/day (≥ 2 times the human auc at the 20 mg dose). risk summary duavee is not indicated for use in females of reproductive potential [see warnings and precautions (5.15)] . conjugated estrogens estrogens are present in human milk and can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. bazedoxifene there are no data on the presence of bazedoxifene in either human or animal breast milk, the effect on the breastfed infant, or the effects on milk production. based on mechanism of action, bazedoxifene may block the important functions that estrogen has in mammary tissue during lactation [see clinical pharmacology (12.1)]. infertility bazedoxifene based on animal data, bazedoxifene administration may adversely affect female fertility. however, clinical fertility studies with bazedoxifene have not been conducted [see nonclinical toxicology (13.1)] . duavee is not indicated for use in children [see indications and usage (1)] . duavee is not recommended for use in women greater than 75 years of age [see dosage and administration (2.7) and clinical pharmacology 12.3)] . of the total number of women in phase 3 clinical studies who received duavee, 4.60% (n=224) were 65 years and over. duavee was not studied in women aged 75 and over. no overall differences in safety or effectiveness were observed between women 65–74 years of age and younger women, and other reported clinical experience has not identified differences in responses between the elderly and younger women, but greater sensitivity of some older women cannot be ruled out. an increased risk of probable dementia in women over 65 years of age was reported in the women's health initiative memory ancillary studies of the women's health initiative using daily conjugated estrogens (0.625 mg) [see clinical studies (14.6)]. duavee is not recommended for use in patients with renal impairment [see dosage and administration (2.6) and clinical pharmacology (12.3)]. the pharmacokinetics, safety, and efficacy of duavee have not been evaluated in women with renal impairment. duavee is contraindicated in patients with hepatic impairment [see contraindications (4) and clinical pharmacology (12.3)]. the pharmacokinetics, safety, and efficacy of duavee have not been evaluated in women with hepatic impairment. in a pharmacokinetics study of bazedoxifene 20 mg alone, the cmax and auc of bazedoxifene increased 67% and 143%, respectively, in women with mild hepatic impairment (child pugh class a), compared to healthy women. the cmax and auc of bazedoxifene increased 32% and 109%, respectively, in women with moderate hepatic impairment (child pugh class b). the cmax and auc of bazedoxifene increased 20% and 268%, respectively, in women with severe hepatic impairment (child pugh class c). no pharmacokinetic studies with conjugated estrogens were conducted in women with hepatic impairment. following duavee administration, the systemic exposures of conjugated estrogens and bazedoxifene were lower in obese subjects, compared to non-obese subjects [see pharmacokinetics (12.3)] . a single dose of duavee (conjugated estrogens 0.45 mg/bazedoxifene 20 mg) was administered to 12 obese bmi ≥ 30 [mean (sd) = 32.7 (2.7) kg/m2 ] and 12 non-obese bmi < 30 [mean (sd) 25.3 (2.6) kg/m2 ] postmenopausal women. in obese subjects, systemic exposures of total estrone, total equilin, and bazedoxifene were 2%, 32%, and 13% lower, respectively, compared to non-obese subjects. a greater reduction in bazedoxifene exposure compared to conjugated estrogens may be associated with decreased protection from endometrial hyperplasia. monitor and evaluate women with postmenopausal or unexplained genital bleeding for possible endometrial hyperplasia or malignancy [see warnings and precautions (5.3)] .

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

method pharmaceuticals, llc - estrogens, esterified (unii: 3asp8q3768) (estrogens, esterified - unii:3asp8q3768), methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - estrogens, esterified 0.625 mg - esterified estrogens and methyltestosterone full strength and esterified estrogens and methyltestosterone half strength are indicated in the treatment of: moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (there is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) esterified estrogens and methyltestosterone full strength and esterified estrogens and methyltestosterone half strength have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus (see boxed warning). estrogens should not be used in women with any of the following conditions: 1.       known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease. 2.       known or suspected estrogen-dependent ne

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

amneal pharmaceuticals of new york llc - estrogens, esterified (unii: 3asp8q3768) (estrogens, esterified - unii:3asp8q3768), methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - estrogens, conjugated 0.625 mg - esterified estrogens and methyltestosterone tablets and esterified estrogens and methyltestosterone tablets h.s. are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (there is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (there is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) esterified estrogens and methyltestosterone tablets and esterified estrogens and methyltestosterone tablets h.s. have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus. esterified estrogens and methyltestosterone tablets and esterified estrogens and methyltestosterone tablets h.s. should not be used in women with any of the following conditions: 1. undiagnosed abnormal genital bleeding. 2. known, suspected, or history of cancer of the breast. 3. known or suspected estrogen-dependent neoplasia. 4. active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. liver dysfunction or disease. 7. esterified estrogens and methyltestosterone tablets and esterified estrogens and methyltestosterone tablets h.s. should not be used in patients with known hypersensitivity to its ingredients. 8. known or suspected pregnancy. there is no indication for esterified estrogens and methyltestosterone tablets and esterified estrogens and methyltestosterone tablets h.s. in pregnancy. there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (see precautions . ) methyltestosterone should not be used in: 1. the presence of severe liver damage. 2. pregnancy and in breast-feeding mothers because of the possibility of masculinization of the female fetus or breast-fed infant.

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

ani pharmaceuticals, inc. - estrogens, esterified (unii: 3asp8q3768) (estrogens, esterified - unii:3asp8q3768), methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - estrogens, esterified 1.25 mg - esterified estrogens and methyltestosterone full and half-strength tablets are indicated in the: esterified estrogens and methyltestosterone full and half-strength tablets should not be used in women with any of the following conditions: methyltestosterone should not be used in: methyltestosterone is classified as a schedule iii controlled substance under the anabolic steroids act of 1990.

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

pfizer australia pty ltd - conjugated estrogens, quantity: 0.45 mg; bazedoxifene acetate, quantity: 22.56 mg (equivalent: bazedoxifene, qty 20 mg) - tablet, modified release - excipient ingredients: lactose monohydrate; hypromellose; microcrystalline cellulose; hyprolose; macrogol 400; magnesium stearate; sucrose palmitate; ascorbic acid; powdered cellulose; calcium phosphate; sucrose; propylene glycol; purified water; isopropyl alcohol; iron oxide black; titanium dioxide; iron oxide red; polydextrose; povidone; hyetellose; maltitol solution; poloxamer - duavive is indicated for treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus.,- duavive should be used for the shortest duration consistent with treatment goals and risks for the individual woman.,- experience in women older than 65 years is limited.

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

u.s. pharmaceuticals - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), bazedoxifene acetate (unii: j70472ud3d) (bazedoxifene - unii:q16tt9c5bk) - estrogens, conjugated 0.45 mg - duavee is indicated in women with a uterus for: - use duavee for the shortest duration consistent with treatment goals and risks for the individual woman. postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. - when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered. duavee is contraindicated in women with any of the following conditions: - undiagnosed abnormal uterine bleeding - known, suspected, or past history of breast cancer - known or suspected estrogen-dependent neoplasia - active deep venous thrombosis, pulmonary embolism, or history of these conditions - active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions - hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients -

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

u.s. pharmaceuticals - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), bazedoxifene acetate (unii: j70472ud3d) (bazedoxifene - unii:q16tt9c5bk) - estrogens, conjugated 0.45 mg - duavee is indicated in women with a uterus for: duavee is contraindicated in women with any of the following conditions: risk summary duavee is contraindicated for use in pregnant women and is not indicated for use in females of reproductive potential [see contraindications (4), warnings and precautions (5.15)]. conjugated estrogens (ce) there are no data with the use of conjugated estrogens in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital and non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives before conception or during early pregnancy. bazedoxifene there are no available data on bazedoxifene use in pregnant women to inform a drug associated risk of adverse developmental outcomes. animal studies have shown that oral bazedoxifene administered during the period of organogenesis to pregnant rats or rabbits at 0.3 and 2 times, respectively, the exposure at the maxi

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx), medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - estrogens, conjugated 0.625 mg - prempro or premphase therapy should not be used in women with any of the following conditions: prempro and premphase should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. prempro and premphase should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogen and progestin have been identified in the breast milk of women receiving these drugs. caution should be exercised when prempro or premphase is administered to a nursing woman. prempro and premphase are not indicated in children. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing prempro or premphase to determine whether those over 65 years of age differ from younger subjects in their response to prempro or premphase. the women's health initiative studies in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.6)] . in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.6)] . the women's health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin or estrogen-alone when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.7)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.7)] . the effects of renal impairment on the pharmacokinetics of prempro or premphase have not been studied. the effects of hepatic impairment on the pharmacokinetics of prempro or premphase have not been studied.

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - estrogens, conjugated 0.625 mg in 1 g -             premarin vaginal cream therapy should not be used in women with any of the following conditions: premarin vaginal cream should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. premarin vaginal cream should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogens have been identified in the breast milk of women receiving estrogen therapy. caution should be exercised when premarin vaginal cream is administered to a nursing woman. premarin vaginal cream is not indicated in children. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing premarin vaginal cream to determine whether those over 65 years of age differ from younger subjects in their response to premarin vaginal cream. the women's health initiative studies in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see warnings and precautions (5.2), and clinical studies (14.2)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see warnings and precautions (5.2, 5.3), and clinical studies (14.2)] . the women's health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.4), and clinical studies (14.3)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.4), and clinical studies (14.3)] . the effect of renal impairment on the pharmacokinetics of premarin vaginal cream has not been studied. the effect of hepatic impairment on the pharmacokinetics of premarin vaginal cream has not been studied.