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<p class="isi-title">IMPORTANT SAFETY INFORMATION AND INDICATIONS</p>
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<p class="container-title">IMPORTANT SAFETY INFORMATION</p>
<p class="container-text bold">Women taking Duavee<sup>®</sup> (conjugated estrogens/bazedoxifene) should not be taking progestins, additional estrogens, or additional estrogen agonist/antagonists.</p>
<p class="container-text bold">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.</p>
<p class="container-text bold">Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia.</p>
<p class="container-text bold">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.</p>
<p class="container-text bold">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.</p>
<p class="container-text bold">Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.</p>
<p class="container-text bold">Estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.</p>
<p class="container-text">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.</p>
<p class="container-text">Estrogen agonist/antagonists, including bazedoxifene, and estrogens individually are known to increase the risk of VTE.</p>
<p class="container-text">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 cancer is unknown.</p>
<p class="container-text">A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown. The effect of treatment with Duavee on the risk of ovarian cancer is unknown.</p>
<p class="container-text">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.</p>
<p class="container-text">Duavee is not recommended for use in patients with renal impairment.</p>
<p class="container-text">Most common adverse reactions (≥ 5 percent) are muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain.</p>
<p class="container-title line-space">INDICATIONS</p>
<p class="container-text">Duavee is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus:</p>
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<li><span>Treatment of moderate to severe vasomotor symptoms associated with menopause</span></li>
<li><span>Prevention of postmenopausal osteoporosis</span></li>
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<p class="container-text"><span class="bold">Limitations of Use:</span> Duavee should be used 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.</p>
<p class="container-text">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.</p>
<p class="container-text line-space"><span class="bold">References: 1.</span> Duavee. Prescribing information. Pfizer; 2022. <span class="bold">2.</span> Kharode Y, Bodine PVN, Miller CP, Lyttle CR, Komm BS. The pairing of a selective estrogen receptor modulator, bazedoxifene, with conjugated estrogens as a new paradigm for the treatment of menopausal symptoms and osteoporosis prevention. <em>Endocrinology</em>. 2008;149(12):6084-6091.</p>
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<div class="container-text line-space" id="end_matter">© 2023 Pfizer Inc. All rights reserved.<br />
<span id="isi_privacy_link">Pfizer Privacy Policy</span>.<br />PP-DUA-USA-0613-01</div>
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