Label: ESTROGEL- estradiol gel, metered

  • NDC Code(s): 17139-617-20, 17139-617-40, 17139-617-43
  • Packager: ASCEND Therapeutics US, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 25, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ESTROGEL safely and effectively. See full prescribing information for ESTROGEL. EstroGel ® 0.06% (estradiol gel) for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER

    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 progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed, persistent, or recurring abnormal genital bleeding  [see Warnings and Precautions ( 5.2)].

    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 Warnings and Precautions ( 5.1), and Clinical Studies ( 14.3)].

    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 Warnings and Precautions ( 5.3), Use in Specific Populations ( 8.5), and Clinical Studies ( 14.4)] .

    Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions ( 5.1, 5.3), and Clinical Studies ( 14.3, 14.4)].

    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.

    Prescribe estrogens with or without progestogens 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

    The WHI estrogen plus progestin substudy reported increased risks of pulmonary embolism (PE), DVT, 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 Warnings and Precautions ( 5.1), and Clinical Studies ( 14.3)].

    The WHIMS estrogen plus progestin ancillary study of 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 Warnings and Precautions ( 5.3), Use in Specific Populations ( 8.5), and Clinical Studies ( 14.4)].

    Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions ( 5.1, 5.3), and Clinical Studies ( 14.3, 14.4)].

    Breast Cancer

    The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions ( 5.2), and Clinical Studies ( 14.4)] .

    Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen 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 plus progestogen therapy, taking into account her individual risk profile.

    Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

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  • 1 INDICATIONS AND USAGE
    1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause - 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use - When ...
  • 2 DOSAGE AND ADMINISTRATION
    Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestogen to reduce the risk of endometrial cancer. Generally, a woman without a uterus ...
  • 3 DOSAGE FORMS AND STRENGTHS
    EstroGel 0.06% is an estradiol transdermal gel. One pump depression delivers 1.25 g of gel that contains 0.75 mg estradiol.
  • 4 CONTRAINDICATIONS
    EstroGel is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding - [see - Warning and Precautions ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular Disorders - Increased risks of stroke and DVT are reported with estrogen-alone therapy. Increased risks of PE, DVT, stroke and MI are reported with estrogen plus progestin ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders - [see - Boxed Warning, and - Warnings ...
  • 7 DRUG INTERACTIONS
    In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - EstroGel is not indicated for use in pregnancy . There are no data with the use of EstroGel in pregnant women, however, epidemiologic studies and meta-analysis have ...
  • 10 OVERDOSAGE
    Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of ...
  • 11 DESCRIPTION
    EstroGel (estradiol gel) contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term, continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas ...
  • 14 CLINICAL STUDIES
    14.1 Effects on Vasomotor Symptoms in Postmenopausal Women - In a placebo-controlled study, 145 postmenopausal women between 29 and 67 years of age (81.4 percent were White) were randomly ...
  • 15 REFERENCES
    Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007;297:1465-1477. Hsia J, et al. Conjugated Equine Estrogens and ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - EstroGel is a clear, colorless, hydroalcoholic 0.06 percent estradiol gel supplied in a non‑aerosol, metered-dose pump. The pump consists of an LDPE inner liner encased in ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise women to read the - FDA-approved patient labeling (Patient Information and Instructions for Use) Vaginal Bleeding - Inform postmenopausal women to report any vaginal ...
  • Patient Information
    EstroGel ® 0.06% (ĕs’ trə jĕl) (estradiol gel) Read this Patient Information before you start using EstroGel, and each time you get a refill. There may be new information. This information ...
  • PRINCIPAL DISPLAY PANEL - EstroGel 50g Canister
    NDC 17139-617-40 - ESTROGel ® 0.06% (estradiol gel) For Topical Use Only. A multiple-dose pump containing 50 grams (1.75 oz) Rx only
  • PRINCIPAL DISPLAY PANEL - EstroGel 50g Carton
    NDC 17139-617-40 - ESTROGel ® 0.06% (estradiol gel) For Topical Use Only. A multiple-dose pump - containing 50 grams (1.75 oz) Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information