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HomePfizer MHT PortfolioHot Flashes/Prevention of Osteoporosis

Hot Flashes/Prevention of Osteoporosis

Duavee(conjugated estrogens/bazedoxifene) 0.45 mg/20 mg tabletsPremarin Tablets
(conjugated estrogens tablets, USP)
Vaginal Symptoms

Vaginal Symptoms

Estring
(estradiol vaginal system) delivers 7.5 mcg per day
Premarin Vaginal Cream(conjugated estrogens) 0.625 mg/g
Savings & Resources
Hormone therapy options for menopause symptoms

Moderate to severe hot flashes and vaginal symptoms, such as vaginal dryness, vaginal itching or irritation, and painful intercourse, can be disruptive, but there are treatment options.1-7

Pfizer has 4 hormone therapy options that are approved to treat select moderate to severe symptoms, like hot flashes and vulvar and vaginal atrophy, for postmenopausal women.4-7 Explore what treatments might be right for your patients.

Estrogens should be used at the lowest dose possible, only for as long as needed.4-7

Selected Safety Information
  • Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia
  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Women taking DUAVEE should not take progestins, additional estrogens, or additional estrogen agonist/antagonists
  • Women’s Health Initiative (WHI) estrogen substudies reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI)
  • The WHI Memory Study (WHIMS) estrogen ancillary studies of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
  • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer

These are not all the risks for these products. Please see full Important Safety Information for more detail on this website.

Explore Pfizer’s menopause hormone therapiesFor moderate to severe hot flashes due to menopause and prevention of postmenopausal osteoporosis*†Women with a uterusdosing: daily oral4 The only combination hormone therapy of its kind for postmenopausal patients with a uterus. Duavee pairs conjugated estrogens (CE) with bazedoxifene (BZA). The BZA component helps protect the uterine lining.4
  • Proven to help provide relief in frequency and severity for moderate to severe hot flashes due to menopause4
  • Helps to increase bone mineral density (BMD) and prevent postmenopausal osteoporosis4
  • Women taking DUAVEE should not take progestins, additional estrogens, or additional estrogen agonist/antagonists4
  • No generic equivalent8
Visit site LoadingLimitations 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.
Dosing: daily oral6 Premarin tablets help reduce the frequency and severity of moderate to severe hot flashes due to menopause and prevent postmenopausal osteoporosis.6
  • Helps to increase bone mineral density and prevent postmenopausal osteoporosis6
  • Offered in 5 dosage strengths of conjugated estrogens to help meet patients individual needs6
  • No generic equivalent9
Visit site LoadingLimitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should 
 only be considered for women at significant risk of osteoporosis and non-estrogen medications should be 
 carefully considered.Premarin tablets 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg.
For moderate to severe vaginal symptoms due to menopause5If a vaginal ring is preferred—dosing: 3-month vaginal ring5 Estring is a soft, flexible ring used after menopause that continuously releases estradiol over 3 months. Estring is for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.5
  • A single ring that lasts 3 months5
  • Demonstrated equal efficacy to conjugated estrogens vaginal cream at 12 weeks in clinical studies5
  • In about 2-3 weeks, Estring restores the tissue of the vagina and urinary tract to a healthier condition5
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If a cream is preferred—dosing: twice-weekly vaginal cream7Premarin Vaginal Cream is a conjugated estrogens cream for the treatment of moderate to severe painful sex, a symptom of vulvar and vaginal atrophy, due to menopause.7
  • Helps rebuild vaginal tissue7
  • A 0.5 g twice-weekly dose of Premarin Vaginal Cream helps relieve moderate to severe painful sex after menopause7
  • No generic equivalent9
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Discover guides, videos, and other resourcesFind other Duavee resources Explore Duavee resources Loading Find other Premarin tablets resources
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References:Lega IC, Fine A, Antoniades ML, Jacobson M. A pragmatic approach to the management of menopause. CMAJ. 2023;195(19):E677-E682. doi:10.1503/cmaj.221438Shen W. Did I just have a hot flash? I’m 44! Johns Hopkins Medicine. Accessed August 15, 2024. https://www.hopkinsmedicine.org/health/wellness-and-prevention/did-i-just-have-a-hot-flash-im-44Kingsberg SA, Krychman M, Graham S, Bernick B, Mirkin S. The Women’s EMPOWER survey: identifying women’s perceptions on vulvar and vaginal atrophy and its treatment. J Sex Med. 2017;14(3):413-424. doi:10.1016/j.jsxm.2017.01.010Duavee. Prescribing information. Pfizer; 2024.Estring. Prescribing information. Pfizer; 2024.Premarin tablets. Prescribing information. Pfizer; 2024.Premarin Vaginal Cream. Prescribing information. Pfizer; 2024.Duavee prices, coupons, copay cards & patient assistance. Drugs.com. Accessed August 15, 2024. https://www.drugs.com/price-guide/duaveeGeneric Premarin availability. Drugs.com. Accessed August 15, 2024. https://www.drugs.com/availability/generic-premarin.html
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*Click here for full terms and conditions

*Eligibility required. No Membership Fees. This is not health insurance. Available to commercially insured patients only. State and federal beneficiaries and cash-paying patients not eligible. For Duavee, savings up to $110 per prescription fill. For Premarin, savings up to $120 per prescription fill. For Premarin Vaginal Cream, savings up to $250 per prescription fill. For Estring, savings up to $360 per prescription fill. Maximum benefit per patient is $1,440 per calendar year. Terms and conditions apply.

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Important Safety Information There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen or using Duavee, which contains bazedoxifene, an estrogen antagonist in the uterus has been shown to reduce the risk of endometrial hyperplasia that can occur with estrogens, and which may be a precursor to endometrial cancer. Women taking DUAVEE should not be taking progestins, additional estrogens, or additional estrogen agonist/antagonists.

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) in postmenopausal women during 7.1 years of treatment with daily oral conjugated estrogens (CE) 0.625mg alone, relative to placebo. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism, stroke, and myocardial infarction in postmenopausal women during 5.6 years of treatment with daily oral CE 0.625mg combined with medroxyprogesterone acetate (MPA) 2.5mg, relative to placebo. Estrogen agonist/antagonists, including bazedoxifene, are also known to increase the risk of VTE. Should any of these occur or be suspected, PREMARIN, PREMARIN Vaginal Cream, ESTRING, or DUAVEE should be discontinued immediately.

The WHI Memory Study (WHIMS) reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older, in both the estrogen-alone and estrogen-plus-progestin arms. It is unknown whether these findings apply to younger postmenopausal women.

The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE or CE and MPA, and other dosage forms of estrogens or combinations and dosage forms of estrogens and progestins.

Estrogens with or without progestins should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.

PREMARIN, PREMARIN Vaginal Cream, ESTRING, and DUAVEE should not be used in women with any of the following conditions: undiagnosed abnormal uterine or genital bleeding; known, suspected, or a history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of venous or arterial thromboembolic disease (eg, stroke, myocardial infarction); anaphylactic reaction, angioedema, or hypersensitivity to PREMARIN, PREMARIN Vaginal Cream, ESTRING, DUAVEE, or any of their ingredients; liver impairment or disease; thrombophilic disorders; pregnancy.

Premarin, Premarin Vaginal Cream, and Estring should not be used during lactation. Duavee is not indicated for use in females of reproductive potential.

In the WHI estrogen-alone substudy, after an average follow-up of 7.1 years, daily conjugated estrogen (0.625 mg)-alone was not associated with an increased risk of invasive breast cancer (relative risk [RR] 0.80).

Observational studies have reported an increased risk of breast cancer for estrogen plus progestin therapy, and a smaller increased risk for estrogen-alone therapy, after several years of use. One large meta-analysis of prospective cohort studies reported increased risks that were dependent upon duration of use and could last up to >10 years after discontinuation of estrogen plus progestin therapy and estrogen-alone therapy. Extension of the WHI trials also demonstrated increased breast cancer risk associated with estrogen plus progestin therapy.

The use of estrogen-alone and estrogen plus progestin 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.

The WHI estrogen plus progestin sub-study reported a statistically non-significant increased risk of ovarian cancer. 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 severe hypercalcemia, 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.

The most common adverse reactions in:
  • DUAVEE (≥ 5%): muscle spasms, nausea, diarrhea, dyspepsia, abdominal pain upper, oropharyngeal pain, dizziness, and neck pain.
  • PREMARIN (≥ 5%): asthenia, flatulence, depression, insomnia, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, and vaginitis.
  • PREMARIN Vaginal Cream (≥ 2%): were vasodilation, leucorrhea, metrorrhagia, vaginitis, and vulvovaginal disorder.
  • ESTRING (≥ 5%): were leukorrhea, genital moniliasis, upper respiratory tract infection, and vaginitis.
IndicationS(Duavee,Premarin Tablets,Premarin Vaginal Cream, Estring)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
     
  • 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 medications should be carefully considered.
Premarin Tablets are indicated for:
  • Treatment of moderate-to-severe vasomotor symptoms due to menopause 
  • Treatment of moderate to severe vulvar and vaginal atrophy due to menopause
  • Prevention of postmenopausal osteoporosis.

Limitations of Use:
  • When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.

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

Premarin Vaginal Cream is indicated for the treatment of atrophic vaginitis and kraurosis vulvae; and for the treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Estring is indicated for the treatment of moderate-to-severe symptoms of vulvar and vaginal atrophy due to menopause.