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| The first and only therapeutically equivalent alternative to ESTRACE® CREAM (estradiol vaginal cream, USP, 0.01%). |
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See Boxed WARNING about endometrial cancer, cardiovascular disorders, breast cancer and probable dementia.
Choose Mylan Estradiol Vaginal Cream, USP, 0.01% for a generic alternative for Estrace® Cream, the #1 prescribed FDA-approved treatment of vulvovaginal atrophy (VVA)1.
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.
Please discuss the Patient Information leaflet with patients for whom you prescribe or dispense estradiol vaginal cream.
For more information about Estradiol Vaginal Cream, USP, 0.01% from Mylan, please call Mylan Customer Relations at 1-800-796-9526.
INDICATIONS AND USAGE
Estradiol Vaginal Cream, USP, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
| Boxed WARNING |
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer 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 (see WARNINGS: Malignant Neoplasms, Endometrial Cancer). Cardiovascular Disorders and Probable Dementia Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia (see CLINICAL STUDIES and WARNINGS: Cardiovascular Disorders, and Probable Dementia). The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) (0.625 mg)-alone, relative to placebo (see CLINICAL STUDIES and WARNINGS: Cardiovascular Disorders). The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (see CLINICAL STUDIES and WARNINGS: Probable Dementia and PRECAUTIONS: Geriatric Use). In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. 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. Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia (see CLINICAL STUDIES and WARNINGS: Cardiovascular Disorders, and Probable Dementia). The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) (2.5 mg), relative to placebo (see CLINICAL STUDIES and WARNINGS: Cardiovascular Disorders). The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (see CLINICAL STUDIES and WARNINGS: Probable Dementia and PRECAUTIONS: Geriatric Use). Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer (see CLINICAL STUDIES and WARNINGS: Malignant Neoplasms, Breast Cancer). In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. 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. |
Estradiol Vaginal Cream, USP, 0.01% 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 Estradiol Vaginal Cream, USP, 0.01%; liver dysfunction or disease; thrombophilic disorders; known or suspected pregnancy.
Systemic absorption may occur with the use of estradiol vaginal cream 0.01%. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.
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 following adverse reactions have been reported with estrogen and/or progestin therapy: Headache, migraine, dizziness, mental depression, breast tenderness, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, vaginal burning, irritation, itching, retinal vascular thrombosis, intolerance to contact lenses. Increase or decrease in weight; glucose intolerance; edema; arthralgias; leg cramps; changes in libido; urticaria; exacerbation of asthma.
Click here for full Prescribing Information, including Boxed WARNING.
References:
| 1. | IMS Health, Inc. NDTI Audit; April 2016-March 2017 |
| 2. | Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause, Vol. 20, No. 9, 2013 |
| 3. | FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed May 3, 2017 |
Mylan- a leading manufacturer of prescription estradiol products across multiple dosage forms3 – is committed to providing high quality treatment options for the healthcare provider and the patients they serve. |
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For more information, visit mylan.com
ESTRACE® is a registered trademark of Allergan Pharmaceuticals International Limited.
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