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DUAVEE®Contraindications (conjugated estrogens/bazedoxifene)

4 CONTRAINDICATIONS

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
Known hepatic impairment or disease
Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders
Pregnancy, as DUAVEE may cause fetal harm [see pregnancy (8.1)].
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