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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.

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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)

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.

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 25 mg in 5 ml - premarin intravenous (conjugated estrogens, usp) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology. premarin intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels. premarin intravenous therapy should not be used in individuals with any of the following conditions:

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - gemtuzumab ozogamicin (unii: 8gzg754x6m) (gemtuzumab ozogamicin - unii:8gzg754x6m) - gemtuzumab ozogamicin 5 mg in 5 ml - mylotarg is indicated for the treatment of newly-diagnosed cd33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. mylotarg is indicated for the treatment of relapsed or refractory cd33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older. mylotarg is contraindicated in patients with a history of hypersensitivity to the active substance in mylotarg or any of its components or to any of the excipients. reactions have included anaphylaxis [see warnings and precautions (5.2), adverse reactions (6)] . risk summary based on its mechanism of action and findings from animal studies [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] , mylotarg can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on mylotarg use in pregnant women to evaluate for a drug-associated risk. in animal reproduction studies, gemtuzumab ozogamicin caused embryo-fetal toxicity, including structural abnormalities and alteration

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wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - desvenlafaxine succinate (unii: zb22enf0xr) (desvenlafaxine - unii:ng99554anw) - desvenlafaxine 50 mg - pristiq is indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185. risk summary based on data from published observational studies, exposure to snris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.4) and clinical considerations] . there are no published studies on pristiq in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see data) . there are risks associated with untreated depression in pregnancy and with expos

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - effexor xr is indicated in adults for the treatment of: effexor xr is contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including effexor xr, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ . risk summary available data from published epidemiologic studies on venlafaxine use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse fetal outcomes (see data) . available data from observational studies with venlafaxine have identified a potential increased risk for preeclampsia when used during mid to late pregnancy; exposure to snris near delivery may increase the risk for postpartum hemorrhage (see clinical considerations)

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

wyeth pharmaceuticals inc., a subsidiary of pfizer inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 20 mg

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 20 mg - protonix for delayed-release oral suspension and protonix delayed-release tablets are indicated for: protonix is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of protonix may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. protonix is indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. protonix is indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. risk summary available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pa

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - temsirolimus (unii: 624kn6gm2t) (temsirolimus - unii:624kn6gm2t) - temsirolimus 25 mg in 1 ml - torisel is indicated for the treatment of advanced renal cell carcinoma. torisel is contraindicated in patients with bilirubin >1.5×uln [see warnings and precautions (5.2)] . risk summary based on findings in animal studies and its mechanism of action, temsirolimus can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . although there are no data on the use of torisel in pregnant women, there are limited data on the use of sirolimus, the active metabolite of temsirolimus, during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal reproductive studies, oral daily administration of temsirolimus to pregnant rats and rabbits during organogenesis caused adverse embryo-fetal effects at approximately 0.04 and 0.12 times the auc in patients at the recommended dose, respectively (see data) . advise pregnant women of the potential hazard to a fetus. the estimated background risk of major birth defects and m