HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DUAVEE safely and effectively. See full prescribing information for DUAVEE.
DUAVEE® (conjugated estrogens/bazedoxifene) tablets for oral use
Initial U.S. approval: 2013 WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIASee full prescribing information for complete Boxed Warning.- Women taking DUAVEE should not take additional estrogens (5.1)
- There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (5.1, 5.3)
- Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.4)
- The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) (5.2)
- 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 (5.4)
INDICATIONS AND USAGEDUAVEE is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus: - Treatment of moderate to severe vasomotor symptoms associated with menopause (1.1)
- 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) DOSAGE AND ADMINISTRATION- Take one tablet orally once daily (2)
DOSAGE FORMS AND STRENGTHSTablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg (3) CONTRAINDICATIONS- Undiagnosed abnormal uterine bleeding (4, 5.3)
- Known, suspected, or past history of breast cancer (4, 5.3)
- Known or suspected estrogen-dependent neoplasia (4, 5.3)
- Active or past history of venous thromboembolism (4, 5.2)
- Active or past history of arterial thromboembolism (4, 5.2)
- Hypersensitivity (angioedema, anaphylaxis) to estrogens, bazedoxifene, or any ingredients (4)
- Known hepatic impairment or disease (4, 5.9, 8.7, 12.3)
- Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders (4)
- Pregnancy (1, 4, 8.1)
WARNINGS AND PRECAUTIONS- Women taking DUAVEE should not take progestins, additional estrogens or additional estrogen agonist/antagonists (5.1)
- Cardiovascular disorders, including venous thromboembolism, pulmonary embolism, stroke, and retinal vascular thrombosis (5.2, 5.6)
- Malignant neoplasms, including endometrial cancer, breast cancer, and ovarian cancer (5.3)
- Estrogens increase the risk of gallbladder disease (5.5)
- Discontinue estrogen if loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.6, 5.8, 5.9)
- Monitor thyroid function in women on thyroid replacement therapy (5.10, 5.17)
ADVERSE REACTIONSIn 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. USE IN SPECIFIC POPULATIONS- 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)
- 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)
- Renal Impairment: DUAVEE was not studied in women with renal impairment; use in this population is not recommended (2.6, 8.6, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 12/2019 |
