Label: MIMVEY- estradiol and norethindrone acetate tablet, film coated

  • NDC Code(s): 0093-5455-28, 0093-5455-42
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 31, 2024

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

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

    Estrogen Plus Progestin Therapy

    Cardiovascular Disorders and Probable Dementia

    The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (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 conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.5)].

    The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and 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 (14.6)].

    Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.15.3), and Clinical Studies (14.514.6)].

    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 (14.5)].

    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.

    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. 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 and Precautions (5.2)].

    Cardiovascular Disorders and Probable Dementia

    The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.5)].

    The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and 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 (14.6)].

    Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.15.3), and Clinical Studies (14.514.6)].

    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.

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  • 1 INDICATIONS AND USAGE
    Mimvey is indicated for: 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    Use estrogen-alone, or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Mimvey tablets are available in one strength: Each tablet of Mimvey (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg contains 1 mg of estradiol and 0.5 mg of norethindrone acetate ...
  • 4 CONTRAINDICATIONS
    Mimvey is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2)] Breast cancer or history of breast cancer [see ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular Disorders - Increased risks of PE, DVT, stroke and MI are reported with estrogen plus progestin therapy. Increased risks of stroke and DVT are reported with estrogen-alone ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)] Malignant Neoplasms [see Boxed ...
  • 7 DRUG INTERACTIONS
    Coadministration of estradiol with norethindrone acetate did not elicit any apparent influence on the pharmacokinetics of norethindrone acetate. Similarly, no relevant interaction of norethindrone ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Estradiol and norethindrone acetate tablets are not indicated for use in pregnancy. There are no data with the use of estradiol and norethindrone acetate in ...
  • 10 OVERDOSAGE
    Overdosage of estrogen plus progestogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose ...
  • 11 DESCRIPTION
    Mimvey® (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol, USP and 0.5 mg of norethindrone acetate, USP and the ...
  • 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 12-week randomized clinical trial involving 92 subjects, estradiol and norethindrone acetate 1 mg/0.5 mg was compared to 1 mg of ...
  • 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 - Mimvey® (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg is available as white, round, biconvex, film-coated, unscored tablet, debossed with stylized b on one ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise women to read the FDA-approved patient labeling (Patient Information) Vaginal Bleeding - Inform postmenopausal women to report any vaginal bleeding to their healthcare provider as soon as ...
  • PATIENT INFORMATION
    Mimvey® (estradiol and norethindrone acetate) Tablets - Read this Patient Information before you start using Mimvey and each time you get a refill. There may be new information. This information ...
  • Package Label Display Panel
    NDC 0093-5455-28 - 1 BLISTER CARD, 28 TABLETS - 28 DAY REGIMEN - Mimvey® (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg - Each white tablet contains 1 mg estradiol, USP and 0.5 mg ...
  • INGREDIENTS AND APPEARANCE
    Product Information