MIMVEY- estradiol and norethindrone acetate tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E), NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Disponible depuis:

Teva Pharmaceuticals USA, Inc.

DCI (Dénomination commune internationale):

ESTRADIOL

Composition:

ESTRADIOL 1 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Mimvey is indicated for: Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 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 Warnings and Precautions (5.2)] - Estrogen-dependent neoplasia [see Warnings and Precautions (5.2 )] - Active DVT, PE, or history of these conditions [see Warnings and Precautions (5.1)] - Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions [see Warnings and Precautions (5.1 )] - Known anaphylactic reaction, angioedema, or hypersensi

Descriptif du produit:

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 side and 34 on the other side. Available in blister cards of 28 tablets: 1 blister card per carton (NDC 0093-5455-28) 5 blister cards per carton (NDC 0093-5455-42) Store in a dry place protected from light. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

MIMVEY- ESTRADIOL AND NORETHINDRONE ACETATE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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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 ACETATE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER,
AND ENDOMETRIAL CANCER
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
ESTROGEN PLUS PROGESTIN THERAPY
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) (5.1)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
INVASIVE
BREAST CANCER (5.2)
THE WHI MEMORY STUDY (WHIMS) ESTROGEN PLUS PROGESTIN ANCILLARY STUDY
OF WHI
REPORTED AN INCREASED RISK OF PROBABLE DEMENTIA IN POSTMENOPAUSAL
WOMEN 65
YEARS OF AGE AND OLDER (5.3)
DO NOT USE ESTROGEN PLUS PROGESTOGEN THERAPY FOR THE PREVENTION OF
CARDIOVASCULAR
DISEASE OR DEMENTIA (5.1, 5.3)
ESTROGEN-ALONE THERAPY
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO USE
UNOPPOSED ESTROGENS (5.2)
THE WHI ESTROGEN-ALONE SUBSTUDY REPORTED INCREASED RISKS OF STROKE AND
DVT (5.1)
THE WHIMS ESTROGEN-ALONE ANCILLARY STUDY OF WHI REPORTED AN INCREASED
RISK OF
PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE AND OLDER
(5.3)
DO NOT USE ESTROGEN-ALONE THERAPY FOR THE PREVENTION OF CARDIOVASCULAR
DISEASE OR
DEMENTIA (5.2, 5.3)
RECENT MAJOR CHANGES
Boxed Warning 8/2021
INDICATIONS AND USAGE
Mimvey is an estrogen and progestin combination indicated in a woman
with a uterus for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
(1.1)
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy
due to Menopause (1.2)
Limitations of Use:
When prescribing solely for the treatment of moderate to severe
symptoms