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 DEMENTIA
|
Boxed warning | 12/2022 |
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)
DUAVEE 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)
- •
- Take one tablet orally once daily (2)
DOSAGE FORMS AND STRENGTHSTablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg (3)
Tablet 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)
- •
- 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)
- •
- 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.
In 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)
- •
- 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: 12/2022