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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)

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: 12/2019

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch