DUAVEE® Highlights

(conjugated estrogens/bazedoxifene)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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

See 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)

RECENT MAJOR CHANGES

Warnings and Precautions, Malignant Neoplasms (5.3)

03/2024

INDICATIONS AND USAGE

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)

DOSAGE FORMS AND STRENGTHS

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)

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 REACTIONS

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)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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

See 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)

RECENT MAJOR CHANGES

Warnings and Precautions, Malignant Neoplasms (5.3)

03/2024

INDICATIONS AND USAGE

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)

DOSAGE FORMS AND STRENGTHS

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)

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 REACTIONS

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)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2024
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