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What is ESTRACE®?

ESTRACE® CREAM is a plant-derived vaginal estrogen cream approved by the FDA to treat moderate to severe vulvar and vaginal atrophy (VVA) symptoms.1

17β-estradiol is structurally and chemically similar to estrogen produced by the ovaries before menopause.1,2

  • There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen doses

4 out of 5 patients with VVA are treated with an estrogen cream when treated for VVA with a prescription.3

The ESTRACE® CREAM experience:

  • Formulated with stearyl alcohol, an emollient that may prevent moisture loss1,4
  • Formulated with nonliquefying base that remains viscous at body temperature5
  • Flexible dosing to meet individual patient needs6

If your patient has moderate to severe VVA, let her know that an option such as ESTRACE® can restore vulvar and vaginal tissue.7

ESTRACE® can help protect against potential long-term tissue damage that may result from using only lubricants to treat moderate to severe VVA.1,6-10

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Dosing Guidelines

[Weeks 1-2]

Initial dose is
2 to 4 grams per day1

[Weeks 3-4]

Gradually reduce to
half initial dose1

[Weeks 5+]

Maintenance dose of
1 gram one to three times per week1

Maintenance dose (1 gram) is about the size of a soybean.1,11

Let your patients know that ESTRACE® can treat dryness, itching, and burning both in and around the vagina.1

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We have your patients covered.

  • 94% of commercial patients have unrestricted access to ESTRACE CREAM12*
  • 88% of Medicare Part D patients have unrestricted access to ESTRACE CREAM12*

In addition, your eligible patients may pay as little as $10 per prescription fill with an ESTRACE® CREAM Savings Card. Eligible patients may sign up for a savings card at estracecream.com.

Savings Card

*Managed Markets Insight and Technology, LLC (MMIT). Database as of January 1, 2017 (estimate derived from the use of information under license from MMIT). Data subject to change.

Depending on insurance coverage, most eligible patients pay as little as $10 for each of up to 4 prescription fills of one (1) 42.5 g tube of brand-name ESTRACE® CREAM each. Check with your pharmacist for your copay discount. Maximum savings limit applies; patient out-of-pocket expense will vary. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Program expires 12/31/18. Please see back of card or click here for Program Terms, Conditions, and Eligibility Criteria.

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Local Estrogen Therapy

The therapeutic standard for moderate to severe VVA.8

Unlike lubricants, estrogen cream may restore the tissue—lubrication, thickness, and elasticity—as well as help resistance to infection and inflammation.6-8

When local estrogen therapy is appropriate, consider plant-derived ESTRACE® vaginal estrogen cream.

  1. ESTRACE® CREAM [package insert]. Irvine, CA: Allergan, USA Inc.; 2017.
  2. Harvard Health Publications Website. What are bioidentical hormones? www.health.harvard.edu/newsweek/What-are-bioidentical-hormones.htm. Accessed March 8, 2017.
  3. IMS Health, Inc. National Prescription AuditTM (NPA): May 2016-May 2017 (information used under license from IMS Health, Inc., which expressly reserves all rights, including rights to copying).
  4. Stearyl alcohol. ChemicalLand21 Website; www.chemicalland21.com/industrialchem/solalc/STEARYL%20ALCOHOL.htm. Accessed March 8, 2017.
  5. Data on file. Clinical Study Report RR09111.0. Allergan: Madison, NJ.
  6. Lynch C. Vaginal estrogen therapy for the treatment of atrophic vaginitis. J Womens Health. 2009:18(10);1595-1606.
  7. Al-Baghdadi O, Ewies A. Topical estrogen therapy in the management of postmenopausal vaginal atrophy: an up-to-date overview. Climacteric. 2009;12:91-105.
  8. North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013;20(9):888-902.
  9. Adriaens E, Remon J. Mucosal irritation potential of personal lubricants relates to product osmolality as detected by the slug mucosal irritation assay. Sex Transm Dis. 2008;35(5):512–516.
  10. Dezzutti CS, Brown ER, Moncla B, et al. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS ONE 7(11): e48328. Published November 7, 2012.
  11. Data on file. Allergan USA Inc.: Madison, NJ.
  12. Managed Markets Insight and Technology, LLCTM, a trademark of MMIT, Database as of January 2017. Data are subject to change.
Indications and Usage

ESTRACE CREAM (estradiol vaginal cream, USP, 0.01%) is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Important Safety Information
WARNINGS: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, 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.

Estrogens with or without progestins 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 with daily oral conjugated estrogens (CE) alone. The WHI estrogen-plus-progestin substudy reported increased risks of DVT, pulmonary embolism, stroke, and myocardial infarction in postmenopausal women with daily oral CE combined with medroxyprogesterone acetate (MPA). In the absence of comparable data, these risks should be assumed to be similar for other dosage forms of estrogens.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens-plus-medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen-alone therapy.

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

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

ESTRACE should not be used in: women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these conditions; active arterial thromboembolic disease (for example, stroke, myocardial infarction) or a history of these conditions; known anaphylactic reaction or angioedema to ESTRACE; liver dysfunction or disease; thrombophilic disorders; known or suspected pregnancy.

Estrogens increase the risk of gallbladder disease. Discontinue estrogen if hypercalcemia, sudden partial or complete loss of vision, hypertriglyceridemia, or cholestatic jaundice occurs. Patients dependent on thyroid hormone replacement therapy should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. Endometriosis may be exacerbated in women treated post-hysterectomy with estrogen-alone therapy. The addition of progestins should be considered in these patients.

The most common side effects include: headache, breast tenderness, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, and vaginal burning, irritation, and itching.

Systemic absorption may occur with the use of ESTRACE CREAM. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.

Please see full Prescribing Information, including Boxed Warning.

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Indications and Usage

ESTRACE CREAM (estradiol vaginal cream, USP, 0.01%) is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Important Safety Information
WARNINGS: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, 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.

Estrogens with or without progestins 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 with daily oral conjugated estrogens (CE) alone. The WHI estrogen-plus-progestin substudy reported increased risks of DVT, pulmonary embolism, stroke, and myocardial infarction in postmenopausal women with daily oral CE combined with medroxyprogesterone acetate (MPA). In the absence of comparable data, these risks should be assumed to be similar for other dosage forms of estrogens.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens-plus-medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen-alone therapy.

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

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

ESTRACE should not be used in: women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these conditions; active arterial thromboembolic disease (for example, stroke, myocardial infarction) or a history of these conditions; known anaphylactic reaction or angioedema to ESTRACE; liver dysfunction or disease; thrombophilic disorders; known or suspected pregnancy.

Estrogens increase the risk of gallbladder disease. Discontinue estrogen if hypercalcemia, sudden partial or complete loss of vision, hypertriglyceridemia, or cholestatic jaundice occurs. Patients dependent on thyroid hormone replacement therapy should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. Endometriosis may be exacerbated in women treated post-hysterectomy with estrogen-alone therapy. The addition of progestins should be considered in these patients.

The most common side effects include: headache, breast tenderness, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, and vaginal burning, irritation, and itching.

Systemic absorption may occur with the use of ESTRACE CREAM. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.

Please see full Prescribing Information, including Boxed Warning.