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    CE & BZA
    Efficacy & Safety
    DUAVEE® Logo
    DUAVEE® Logo

    Proven Efficacy

    Announcement Title

    Please be advised that DUAVEE is currently out of stock. For medical questions on DUAVEE and for supply updates, please contact Pfizer Medical Information at 1‑800‑438‑1985.

    DUAVEE® (conjugated estrogens/bazedoxifene) tablets significantly reduced moderate to severe hot flashes due to menopause and significantly increased bone mineral density (BMD) of lumbar spine and total hip compared to placebo​​​​​​​​​​​​​​​​​​​

    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.

    Hot flashes

    BMD

    DUAVEE offers significant reduction vs placebo in the average daily frequency and severity of moderate to severe hot flashes due to menopause1​​​​​​​

    Adjusted mean change from baseline in the average daily frequency and severity score of moderate to severe hot flashes at week 12 (Study 3)1

    *Average daily severity score = (number mild flashes) x 1 + (number moderate flashes) x 2 + (number severe flashes) x 3 divided by total number of flashes on that day.
    P<.001 vs placebo.
    Based on data analysis using ANCOVA model: Difference = Treatment + Baseline + Site.

    At week 12, the average daily number of moderate to severe hot flashes was reduced from 10.3/day to 2.8/day for DUAVEE and from 10.5 to 5.4 for placebo2*

    *Based on mathematical means, not statistically analyzed.
    DUAVEE n=122; placebo n=63.

    Study description

    Study 3
    A multicenter, double-blind, randomized, placebo-controlled, 12-week study of bazedoxifene/conjugated estrogens combinations for the treatment of vasomotor symptoms associated with menopause in postmenopausal women with a uterus. The primary endpoints were change from baseline at weeks 4 and 12 in 1) the average daily number of moderate to severe hot flashes and 2) average daily severity score of hot flashes. The study enrolled 318 women, aged 42-64 years (mean 53 years), who had at least 7 moderate to severe hot flashes/day or 50/wk. Postmenopausal was defined as at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH level >40 mIU/mL. The mean number of years since menopause was 4.5 years. A total of 127 women were assigned to DUAVEE, 63 women were assigned to placebo, and 128 assigned to another dose of bazedoxifene/conjugated estrogens.

    References:
    1. DUAVEE [package insert]. New York, NY: Pfizer Inc.; 2019.
    2. Data on file. Pfizer Inc., New York, NY.

    Efficacy & Safety

    INDICATIONS

    DUAVEE is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus:

    • Treatment of moderate to severe vasomotor symptoms associated with menopause
    • Prevention of postmenopausal osteoporosis

    Limitation of Use: DUAVEE should be used for the shortest duration consistent with treatment goals and risks for the individual woman.

    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 pregnant 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 a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus:

    • Treatment of moderate to severe vasomotor symptoms associated with menopause
    • Prevention of postmenopausal osteoporosis

    Limitation of Use: DUAVEE should be used for the shortest duration consistent with treatment goals and risks for the individual woman.

    Please see Full Prescribing Information, including BOXED WARNING and Patient Information.