Bazedoxifene

DUAVEE pairs conjugated estrogens with bazedoxifene. Conjugated estrogens and bazedoxifene function by binding to and activating estrogen receptors (ER) α and β, which vary in proportion from tissue to tissue.

• DUAVEE is indicated in women with a uterus for: 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 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause 1.2 Prevention of Postmenopausal Osteoporosis 1.3 Important Limitations of Use • Use DUAVEE for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.ICD-10: M81.0, N95.1

• DUAVEE is contraindicated in women with any of the following conditions: • Undiagnosed abnormal uterine bleeding • Known, suspected, or past history of breast cancer • Known or suspected estrogen-dependent neoplasia • Active deep venous thrombosis, pulmonary embolism, or history of these conditions • Active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions • Hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients • Known hepatic impairment or disease • Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders • Pregnancy, as DUAVEE may cause fetal harm [see pregnancy (8.1) ] .contraindicated

• Take one tablet orally once daily ( 2 ) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause The recommended dosage is one DUAVEE tablet daily. 2.2 Prevention of Postmenopausal Osteoporosis The recommended dosage is one DUAVEE tablet daily. 2.3 General Dosing Information Take DUAVEE once daily, without regard to meals. Tablets should be swallowed whole. 2.4 Recommendations for Calcium and Vitamin D Supplementation Women taking DUAVEE for prevention of postmenopausal osteoporosis should add supplemental calcium and/or vitamin D to their diet if daily intake is inadequate. 2.5 Administration Instructions for Missed Doses If a dose of DUAVEE is missed, instruct patients to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. 2.6 Use in Patients with Renal Impairment The pharmacokinetics of DUAVEE have not been evaluated in patients with renal impairment. Use in patients with renal impairment is not recommended [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . 2.7 Use in the Elderly DUAVEE has not been studied in women over 75 years of age. Use in women over 75 years of age is not recommended.

• 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 ) 5.1 Drugs Containing Progestins, Estrogens or Estrogen Agonist/Antagonists DUAVEE contains conjugated estrogens and bazedoxifene, an estrogen agonist/antagonist. Women taking DUAVEE should not take progestins, additional estrogens or additional estrogen agonist/antagonists. 5.2 Cardiovascular Disorders Estrogen agonist/antagonists (including bazedoxifene, a component of DUAVEE) and estrogens individually are known to increase the risk of VTE. An increased risk of stroke and DVT has been reported with estrogen-alone therapy. Should any of these occur or be suspected, DUAVEE should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or VTE (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

The following adverse reactions are discussed in greater detail in other sections of the label: • Cardiovascular Disorders [see Warnings and Precautions (5.2) ] • Malignant Neoplasms [see Warnings and Precautions (5.3) ] • Gallbladder Disease [see Warnings and Precautions (5.5) ] • Hypertriglyceridemia [see Warnings and Precautions (5.8) ] 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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of conjugated estrogens/bazedoxifene was evaluated in four Phase 3 clinical trials ranging from 12 weeks to 24 months in duration and enrolling 6,210 postmenopausal women age 40 to 75 years (mean age 55 years). A total of 1,224 patients were treated with DUAVEE and 1,069 patients received placebo. Women enrolled in Studies 1 and 2 received calcium (600–1200 mg) and vitamin D (200–400 IU) daily, while women in Studies 3 and 4 received no calcium and vitamin D supplementation as part of the protocol.

• 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 ) 8.1 Pregnancy Risk Summary DUAVEE is contraindicated for use in pregnant women and is not indicated for use in females of reproductive potential [see Contraindications (4) , Warnings and Precautions (5.15) ]. Conjugated Estrogens (CE) There are no data with the use of conjugated estrogens in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital and non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives before conception or during early pregnancy. Bazedoxifene There are no available data on bazedoxifene use in pregnant women to inform a drug associated risk of adverse developmental outcomes.

Metabolism

Absorption Following administration of multiple doses of conjugated estrogens 0.45 mg/bazedoxifene 20 mg to healthy women who were naturally postmenopausal or who had undergone bilateral oophorectomy, the mean steady state pharmacokinetic parameters at Day 10 for conjugated estrogens (baseline adjusted for total estrone) and bazedoxifene are summarized in Table 2.

In case of overdosage, there is no specific antidote, and the treatment should be symptomatic. Symptoms of overdosage of estrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur.

• Oct 3, 2013NDANDA022247Wyeth Pharms

1. 1Drug Ineffective14015%
2. 2Hot Flush788.4%
3. 3Nausea424.5%
4. 4Muscle Spasms414.4%
5. 5Off Label Use394.2%
6. 6Weight Increased353.8%
7. 7Feeling Abnormal333.5%
8. 8Headache333.5%
9. 9Dizziness313.3%
10. 10Insomnia313.3%
11. 11Pain313.3%
12. 12Therapeutic Response Unexpected252.7%
13. 13Arthralgia242.6%
14. 14Pain In Extremity232.5%
15. 15Drug Effect Incomplete222.4%

The 10 most recently updated of 55 ClinicalTrials.gov registrations naming Bazedoxifene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Bazedoxifene -Treatment for Women With Schizophrenia
  Recruiting · Phase 4 · Interventional · 160 enrolled · The Alfred
  NCT04113993updated 2026-06-03
• Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
  Active not recruiting · Phase 2 · Interventional · 120 enrolled · University of Kansas Medical Center
  NCT04821141updated 2025-10-29
• Pilot Study of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers
  Completed · Early phase 1 · Interventional · 16 enrolled · Carol Fabian, MD
  NCT04821375updated 2025-10-29
• Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis
  Completed · Phase 2 · Interventional · 63 enrolled · Riley Bove, MD
  NCT04002934updated 2025-06-08
• Raising Insulin Sensitivity in Post Menopause
  Completed · Early phase 1 · Interventional · 8 enrolled · Pennington Biomedical Research Center
  NCT02274571updated 2025-06-04
• The PROMISE Study: Duavee in Women With DCIS
  Completed · Phase 2 · Interventional · 142 enrolled · Northwestern University
  NCT02694809updated 2025-01-28
• Advancing Postmenopausal Preventive Therapy
  Active not recruiting · Phase 2 · Interventional · 385 enrolled · University of Southern California
  NCT04103476updated 2024-12-05
• Affect of Duavive on Mood & Anxiety Symptoms
  Recruiting · Phase 1 · Interventional · 30 enrolled · St. Joseph's Healthcare Hamilton
  NCT04478305updated 2024-12-03
• Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee
  Recruiting · Phase 4 · Interventional · 28 enrolled · Penn State University
  NCT05059626updated 2024-11-05
• Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans
  Withdrawn · Phase 2 · Interventional · 0 enrolled · VA Office of Research and Development
  NCT05073237updated 2024-05-10

Frequently asked questions

How does Bazedoxifene work?

DUAVEE pairs conjugated estrogens with bazedoxifene. Conjugated estrogens and bazedoxifene function by binding to and activating estrogen receptors (ER) α and β, which vary in proportion from tissue to tissue.

What is Bazedoxifene used for?

According to FDA labeling, Bazedoxifene carries indications including: DUAVEE is indicated in women with a uterus for: 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 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause 1.2 Prevention of Postmenopausal Osteoporosis 1.3 Important Limitations of Use • Use DUAVEE for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Bazedoxifene?

Bazedoxifene is classified as Selective estrogen receptor modulators, Estrogen Agonist/Antagonist, Selective Estrogen Receptor Modulators, Bone Resorption Inhibition.

What are the brand names for Bazedoxifene?

Bazedoxifene is marketed under brand names including Duavee.

What are the contraindications for Bazedoxifene?

Bazedoxifene labeling lists contraindications including: DUAVEE is contraindicated in women with any of the following conditions: • Undiagnosed abnormal uterine bleeding • Known, suspected, or past history of breast cancer • Known or suspected estrogen-dependent neoplasia • Active deep venous thrombosis, pulmonary embolism, or history of these conditions • Active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions • Hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients • Known hepatic impairment or disease • Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders • Pregnancy, as DUAVEE may cause fetal harm [see pregnancy (8.1) ] .. Always consult the full prescribing information and a clinician.