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

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Treatment of moderate to severe vasomotor symptoms associated with menopause (1.1)

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Prevention of postmenopausal osteoporosis (1.2)

Limitation of Use: DUAVEE should be used for the shortest duration consistent with treatment goals and risks for the individual woman (1.3)

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Take one tablet orally once daily (2)

Tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg (3)

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Undiagnosed abnormal uterine bleeding (4, 5.3)

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Known, suspected, or past history of breast cancer (4, 5.3)

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Known or suspected estrogen-dependent neoplasia (4, 5.3)

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Active or past history of venous thromboembolism (4, 5.2)

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Active or past history of arterial thromboembolism (4, 5.2)

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Hypersensitivity (angioedema, anaphylaxis) to estrogens, bazedoxifene, or any ingredients (4)

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Known hepatic impairment or disease (4, 5.9, 8.7, 12.3)

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Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders (4)

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Pregnancy (1, 4, 8.1)

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Women taking DUAVEE should not take progestins, additional estrogens or additional estrogen agonist/antagonists (5.1)

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Cardiovascular disorders, including venous thromboembolism, pulmonary embolism, stroke, and retinal vascular thrombosis (5.2, 5.6)

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Malignant neoplasms, including endometrial cancer, breast cancer, and ovarian cancer (5.3)

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Estrogens increase the risk of gallbladder disease (5.5)

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Discontinue estrogen if loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.6, 5.8, 5.9)

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Monitor thyroid function in women on thyroid replacement therapy (5.10, 5.17)

In four prospective, randomized, placebo-controlled trials the common adverse reactions (incidence ≥ 5%) were muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Geriatric Use: DUAVEE was not studied in women aged 75 or older (8.5, 12.3); use in this population is not recommended (2.7, 8.5)

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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 (5.4, 8.5, 14.6)

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Renal Impairment: DUAVEE was not studied in women with renal impairment; use in this population is not recommended (2.6, 8.6, 12.3)