IMPORTANT SAFETY INFORMATION AND INDICATION
Women taking DUAVEE® (conjugated estrogens/bazedoxifene) should not be taking progestins, additional estrogens, or additional estrogen agonist/antagonists.
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. DUAVEE contains bazedoxifene, an estrogen agonist/antagonist, to reduce the risk of endometrial hyperplasia that can occur with estrogens, and which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling, when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia.
The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT). Should any of these occur or be suspected, DUAVEE should be discontinued immediately.
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.
DUAVEE should not be used in women with undiagnosed abnormal uterine bleeding; known, suspected, or past history of breast cancer or estrogen-dependent neoplasia; active or past history of venous or arterial thromboembolism; hypersensitivity to estrogens, bazedoxifene, or any ingredients; known hepatic impairment or disease; known thrombophilic disorders. Women who are or may become pregnant and nursing mothers should not use DUAVEE.
Estrogen agonist/antagonists, including bazedoxifene, and estrogens individually are known to increase the risk of VTE.
The use of estrogen-alone has been reported to result in an increase in abnormal mammograms requiring further evaluation. The effect of treatment with DUAVEE on the risk of breast and ovarian cancer is unknown.
Estrogens increase the risk of gallbladder disease. Discontinue estrogen if loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs. Monitor thyroid function in women on thyroid replacement therapy, because estrogens may be associated with increased thyroid binding globulin (TBG) levels.
Adverse reactions more common in the DUAVEE treatment group in four placebo-controlled studies were muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain.
DUAVEE is indicated in women with a uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis.
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.
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.