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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Contraindications

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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