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Prescribing Information, including BOXED WARNINGPatient InformationIndicationsPatient Site
Back in Stock!Duavee® (conjugated estrogens/bazedoxifene) is now available.Safety and TolerabilityThe safety and tolerability of Duavee were evaluated in 4 phase III trials ranging from 12 weeks to 24 months in duration1
 
Duavee 
(n=1224) 
n (%)
Placebo
(n=1069) 
n (%)
Gastrointestinal disorders
Nausea 100 (8) 58(5)
Diarrhea 96(8) 57(5)
Dyspepsia 84(7) 59(6)
Abdominal pain upper 81(7) 58(5)
Musculoskeletal and connective tissue disorders
Muscle spasms 110(9) 63(6)
Neck pain 62(5) 46(4)
Nervous system disorders
Dizziness 65(5) 37(3)
Respiratory, thoracic, and mediastinal disorders
Oropharyngeal pain 80(7) 61(6)
Adverse events (AEs)Adverse reactions (incidence ≥5%) more common in the Duavee treatment group in placebo-controlled trials1
Scroll left to view table
 
Duavee 
(N=1224) 
n (%)
Placebo
(N=1069) 
n (%)
Gastrointestinal disorders
Nausea 100 (8) 58 (5)
Diarrhea 96 (8) 57 (5)
Dyspepsia 84 (7) 59 (6)
Abdominal pain upper 81 (7) 58 (5)
Musculoskeletal and connective tissue disorders
Muscle spasms 110 (9) 63 (6)
Neck pain 62 (5) 46 (4)
Nervous system disorders
Dizziness 65 (5) 37 (3)
Respiratory, thoracic, and mediastinal disorders
Oropharyngeal pain 80 (7) 61 (6)
Serious AEs

Incidence of serious AEs was 3.5% in the Duavee group vs 4.8% in the placebo group.1

Discontinuations due to AEs

Discontinuations due to AEs similar to placebo1

The most common AEs leading to discontinuations were hot flash (Duavee 0.7%; placebo 1.8%), abdominal pain upper (Duavee 0.5%; placebo 0.5%), and nausea (Duavee 0.5%; placebo 0.7%)1,2

Cumulative amenorrhea incidence over 1 year1The majority of patients treated with Duavee reported no breakthrough bleeding1*In 2 separate studies, 8 of 10 patients reported no bleeding or spotting from the start of treatment through the course of 1 year, comparable to placebo1*Based on daily diary.1
The number of women included in the analysis of cumulative amenorrhea were as follows:
 Study 1: Duavee n=429; placebo n=421. Study 2: Duavee n=355; placebo n=379.2
Endometrial hyperplasia<1% incidence of endometrial hyperplasia or malignancy1*The systemic exposures of both CE and BZA were lower in obese subjects (BMI ≥30) compared to nonobese subjects. A greater reduction in BZA exposure compared to CE may be associated with decreased protection from endometrial hyperplasia.1*Based on endometrial biopsy.1VTEVenous thromboembolism (VTE) from clinical trial data1
  • The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT). Should any of these occur or be suspected, Duavee should be discontinued immediately
  • Estrogen agonist/antagonists, including bazedoxifene, and estrogens individually are known to increase the risk of VTE
  • In the clinical studies with Duavee, the reporting rates for VTE* were low in all treatment groups. Adverse reactions of VTE were reported in 0.0% of patients treated with Duavee (N=1224) and 0.1% of patients treated with placebo (N=1069)
  • Due to the low rate of events in both groups, it is not possible to conclude that the risk of VTE with Duavee is different from that seen with other estrogen therapies
*Deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis.
References:Duavee. Prescribing information. Pfizer; 2024.Data on file, Pfizer Inc., New York, NY.
Efficacy & Safety

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INDICATIONSDuavee® (conjugated estrogens/‌‌bazedoxifene) 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
  • Prevention of postmenopausal osteoporosis
Limitations of Use: Duavee should be used 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.

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
Important Safety Information

Women taking Duavee® (conjugated estrogens/‌bazedoxifene) should not be taking progestins, additional estrogens, or additional estrogen agonist/‌antagonists.

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Duavee contains bazedoxifene, an estrogen agonist/‌antagonist, to reduce the risk of endometrial hyperplasia that can occur with estrogens, and which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT). Should any of these occur or be suspected, Duavee should be discontinued immediately.

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.

Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.

Estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.


Duavee should not be used in women with undiagnosed abnormal uterine bleeding; known, suspected, or past history of breast cancer or estrogen-dependent neoplasia; active or past history of venous or arterial thromboembolism; hypersensitivity to estrogens, bazedoxifene, or any ingredients; known hepatic impairment or disease; known thrombophilic disorders. Women who are pregnant should not use Duavee.

Estrogen agonist/‌antagonists, including bazedoxifene, and estrogens individually are known to increase the risk of VTE.

The use of estrogen alone has been reported to result in an increase in abnormal mammograms requiring further evaluation. The effect of treatment with Duavee on the risk of breast cancer is unknown.

A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown. The effect of treatment with Duavee on the risk of ovarian cancer is unknown.

Estrogens increase the risk of gallbladder disease. Discontinue estrogen if loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs. Monitor thyroid function in women on thyroid replacement therapy, because estrogens may be associated with increased thyroid binding globulin (TBG) levels.

Duavee is not recommended for use in patients with renal impairment. 

Most common adverse reactions (≥ 5 percent) are muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain.

IndicationsDuavee 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
  • Prevention of postmenopausal osteoporosis
Limitations of Use: Duavee should be used 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.

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.

Please see full Prescribing Information, including BOXED WARNING and Patient Information.