Label: ELESTRIN- estradiol gel, metered

  • NDC Code(s): 0037-4801-35, 0037-4801-70
  • Packager: Meda Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 15, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ELESTRIN safely and effectively. See full prescribing information for ELESTRIN.   Elestrin® (estradiol gel), for topical ...
  • 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 progestin 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

    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 (14.2, 14.3)].

    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 (14.2)].

    The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the 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 (14.3)].

    Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of 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 progestins 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

    Do not use estrogen plus progestin therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.2, 14.3)].

    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 Warnings and Precautions (5.1), and Clinical Studies (14.2)].

    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 Warnings and Precautions (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.3)].

     
    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 (14.2)].

    Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of 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 progestin 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 progestin therapy, taking into account her individual risk profile.

    Prescribe estrogens with or without progestins 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
  • 2 DOSAGE AND ADMINISTRATION
    Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestin to reduce the risk of endometrial cancer. Generally, a woman without a uterus ...
  • 3 DOSAGE FORMS AND STRENGTHS
    ELESTRIN is available in a metered dose pump which delivers 0.52 mg of estradiol in 0.87 grams of gel per pump actuation.
  • 4 CONTRAINDICATIONS
    ELESTRIN is contraindicated in women with any of the following conditions: • Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2)]. • Breast cancer or a history of breast ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular Disorders - Increased risk of stroke and DVT are reported with estrogen-alone therapy. Increased risk 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 and Precautions (5.1)]. • Malignant Neoplasms [see ...
  • 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 metabolism ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - ELESTRIN is not indicated for use in pregnancy. There are no data with the use of ELESTRIN in pregnant women; however, epidemiologic studies and meta-analyses ...
  • 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
    ELESTRIN (estradiol gel) contains 0.06% of estradiol, in a colorless, non-staining hydroalcoholic gel base. One pump actuation delivers ELESTRIN in a unit dose of 0.52 mg of estradiol in 0.87 g ...
  • 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 - A randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy of 12-week treatment with three different daily ...
  • 15 REFERENCES
    1. Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007;297:1465-1477. 2. Hsia J, et al. Conjugated Equine Estrogens ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Elestrin (estradiol gel) 0.06% in a colorless, non-staining hydroalcoholic gel supplied in a non-aerosol, metered-dose pump container constructed of polypropylene. The drug ...
  • 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 bleeding to their ...
  • PATIENT INFORMATION
    ELESTRIN® (el-LES-strin) (estradiol gel) Read this Patient Information before you start using ELESTRIN and each time you get a refill. There may be new information. This information does not ...
  • INSTRUCTIONS FOR USE
    ELESTRIN® (el-LES-strin) (estradiol gel) 1. Remove the cap. 2. Activate the pump. • Unlock the pump by turning the spout on top of the bottle a quarter turn to the left or the ...
  • PRINCIPAL DISPLAY PANEL – 0.06%
    NDC 0037-4801-70 - Elestrin® (estradiol gel) 0.06% 0.52 mg of estradiol per pump actuation* FOR TOPICAL USE ONLY - Total Contents: 35g x 2 - Rx Only - Metered dose pump - container delivering - 26 ...
  • INGREDIENTS AND APPEARANCE
    Product Information