Label: MINIVELLE- estradiol film, extended release

  • NDC Code(s): 68968-6610-8, 68968-6625-8, 68968-6637-8, 68968-6650-8, view more
  • Packager: Noven Therapeutics, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 22, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MINIVELLE safely and effectively. See full prescribing information for MINIVELLE. MINIVELLE® (estradiol transdermal ...
  • 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 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 (14.4)].

    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 route 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 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 (14.3)].

    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 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 (14.4)].

    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 (14.3)].

    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
    MINIVELLE is indicated for: 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause - 1.2 Prevention of Postmenopausal Osteoporosis - Limitation of Use - When prescribing ...
  • 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
    Transdermal system: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day.
  • 4 CONTRAINDICATIONS
    MINIVELLE 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 cancer ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular Disorder - 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 labeling: Cardiovascular Disorders [see Boxed Warning, Warning and Precaution, (5.1)] Malignant Neoplasms [see Boxed Warning ...
  • 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 - MINIVELLE is not indicated for use in pregnancy. There are no data with the use of MINIVELLE 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
    MINIVELLE (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage ...
  • 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 - There have been no efficacy and safety trials conducted with MINIVELLE. In a pharmacokinetic study, MINIVELLE was shown to be ...
  • 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 - MINIVELLE (estradiol transdermal system), 0.025 mg per day - each 1.65 cm2 system contains 0.41 mg of estradiol USP for nominal* delivery of 0.025 mg of estradiol per ...
  • 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 unusual vaginal bleeding to their ...
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - MINIVELLE (MIN-ee-vell) (estradiol transdermal system) Read this Patient Information before you start using MINIVELLE and each time you get a refill. There may be new ...
  • INSTRUCTIONS FOR USE
    INSTRUCTIONS FOR USE - MINIVELLE® (MIN-ee-vell) (estradiol transdermal system) Read this PATIENT INFORMATION before you start using MINIVELLE and each time you get a refill. There may be new ...
  • Package Label - Principal Display Panel – 0.025mg Trade Carton
    NDC 68968-6625-8 - 0.025 mg/day - Minivelle® (estradiol transdermal system) Delivers 0.025 mg/day - Twice-Weekly - Rx Only - Includes 8 Systems - ​Open Here​ ​Contents: 8 Systems​ Rx Only - Each ...
  • Package Label - Principal Display Panel – 0.0375mg Carton
    NDC 68968-6637-8 - 0.0375 mg/day - Minivelle® (estradiol transdermal system) Delivers 0.0375 mg/day - Twice-Weekly - Rx Only - Includes 8 Systems - ​Open Here - Contents: 8 Systems - Rx ...
  • Package Label - Principal Display Panel – 0.05mg Carton
    ​NDC 68968-6650-8 - 0.05 mg/day - Minivelle® (estradiol transdermal system) Delivers 0.05 mg/day - Twice-Weekly - Rx Only - Includes 8 Systems - Open Here - Contents: 8 Systems - Rx Only - Each ...
  • Package Label - Principal Display Panel – 0.075mg Carton
    ​NDC 68968-6675-8 - 0.075 mg/day - Minivelle® (estradiol transdermal system) Delivers 0.05 mg/day - Twice-Weekly - Rx Only - Includes 8 Systems - Open Here - Contents: 8 Systems - Rx Only - Each ...
  • Package Label - Principal Display Panel – 0.1mg Carton
    NDC 68968-6610-8 - 0.1 mg/day - Minivelle® (estradiol transdermal system) Delivers 0.05 mg/day - Twice-Weekly - Rx Only - Includes 8 Systems - Open Here - Contents: 8 Systems - Rx Only - Each 6.6 ...
  • INGREDIENTS AND APPEARANCE
    Product Information