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Duavee (Bazedoxifene Acetate)
Pairs conjugated estrogens with bazedoxifene to bind and activate estrogen receptors α and β with tissue-specific effects.
DUAVEE is a combination hormone therapy pairing conjugated estrogens with bazedoxifene, a selective estrogen receptor modulator, indicated for moderate to severe vasomotor symptoms and postmenopausal osteoporosis prevention in women with a uterus. The bazedoxifene component provides tissue-selective antagonism in the uterus, reducing endometrial hyperplasia risk compared to estrogen monotherapy. Key risks include cardiovascular events, malignant neoplasms, and venous thromboembolism, requiring careful patient selection and periodic re-evaluation. The drug should be used for the shortest duration consistent with individual treatment goals and risk profiles.
At a glance
| Generic name | Bazedoxifene Acetate |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Estrogen agonist/antagonist combination |
| Target | Estrogen receptors (ER) α and β |
| Modality | Small molecule |
| Therapeutic area | Bone |
| Phase | FDA-approved |
Mechanism of action
DUAVEE combines conjugated estrogens with bazedoxifene, both of which bind to and activate estrogen receptors α and β. Conjugated estrogens function as agonists at both ER-α and ER-β, while bazedoxifene acts as a selective estrogen receptor modulator (SERM), functioning as an agonist in some estrogen-sensitive tissues and an antagonist in others, such as the uterus. The pairing produces a composite effect specific to each target tissue, with the bazedoxifene component reducing the risk of endometrial hyperplasia that can occur with conjugated estrogens alone.
Approved indications
- Treatment of moderate to severe vasomotor symptoms associated with menopause
- Prevention of postmenopausal osteoporosis
Boxed warnings
- WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA • Women taking DUAVEE should not take additional estrogens [see Warnings and Precautions (5.1) ] • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. DUAVEE has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should
Common side effects
- Muscle spasms
- Nausea
- Diarrhea
- Dyspepsia
- Abdominal pain upper
- Oropharyngeal pain
- Dizziness
- Neck pain
Serious adverse events
- Serious adverse reactions
- Venous thromboembolism
Drug interactions
- Itraconazole (strong CYP3A4 inhibitor)
- St. John's Wort (Hypericum perforatum), phenobarbital, carbamazepine, rifampin (CYP3A4 inducers)
- Rifampin, phenobarbital, carbamazepine, phenytoin (UGT inducers)
- Atorvastatin