DUAVEE- conjugated estrogens/bazedoxifene tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX), BAZEDOXIFENE ACETATE (UNII: J70472UD3D) (BAZEDOXIFENE - UNII:Q16TT9C5BK)

Tilgjengelig fra:

U.S. Pharmaceuticals

INN (International Name):

ESTROGENS, CONJUGATED

Sammensetning:

ESTROGENS, CONJUGATED 0.45 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

DUAVEE is indicated in women with a uterus for: DUAVEE is contraindicated in women with any of the following conditions: Risk Summary DUAVEE is contraindicated for use in pregnant women and is not indicated for use in females of reproductive potential [see Contraindications (4), Warnings and Precautions (5.15)]. Conjugated Estrogens (CE) There are no data with the use of conjugated estrogens in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital and non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives before conception or during early pregnancy. Bazedoxifene There are no available data on bazedoxifene use in pregnant women to inform a drug associated risk of adverse developmental outcomes. Animal studies have shown that oral bazedoxifene administered during the period of organogenesis to pregnant rats or rabbits at 0.3 and 2 times, respectively, the exposure at the maxi

Produkt oppsummering:

DUAVEE tablets contain 0.45 mg conjugated estrogens and 20 mg bazedoxifene. The tablets are oval, biconvex, and pink, branded with "0.45/20" in black ink on one side. DUAVEE® tablets are supplied as follows: Conjugated estrogens 0.45 mg/bazedoxifene 20 mg 2 blisters of 15 tablets each NDC 0008-1123-12 Storage Blisters DUAVEE tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Dispense product in the original package. Tablets should not be removed from blisters until immediately before use. Protect from moisture. After opening foil pouch, product must be used within 60 days.

Autorisasjon status:

New Drug Application

Preparatomtale

DUAVEE- CONJUGATED ESTROGENS/BAZEDOXIFENE TABLET, FILM COATED
U.S. PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUAVEE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DUAVEE.
DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE
DEMENTIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Boxed Warning
12/2022
INDICATIONS AND USAGE
DUAVEE is a combination of conjugated estrogens with an estrogen
agonist/antagonist indicated for
treatment of the following conditions in women with a uterus:
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Limitation of Use: DUAVEE should be used for the shortest duration
consistent with treatment goals and
risks for the individual woman (1.3)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg
(3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
®
WOMEN TAKING DUAVEE SHOULD NOT TAKE ADDITIONAL ESTROGENS (5.1)
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO
USES UNOPPOSED ESTROGENS (5.1, 5.3)
ESTROGEN THERAPY SHOULD NOT BE USED FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE
OR DEMENTIA (5.2, 5.4)
THE WOMEN'S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED
INCREASED
RISKS OF STROKE AND DEEP VEIN THROMBOSIS (DVT) (5.2)
THE WHI MEMORY STUDY (WHIMS) ESTROGEN-ALONE ANCILLARY STUDY OF WHI
REPORTED AN
INCREASED RISK OF PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS
OF AGE
AND OLDER (5.4)
Treatment of moderate to severe vasomotor symptoms associated with
menopause (1.1)
Prevention of postmenopausal osteoporosis (1.2)
Take one tablet orally once daily (2)
Undiagnosed abnormal uterine bleeding (4, 5.3)
Known, suspected, or past history of breast cancer (4, 5.3)
Known or suspected estrogen-dependent neoplasia (4, 5.3)
Active or past hist