IMVEXXY® (estradiol vaginal inserts) - Official Physician Website
Time 2022-09-17 20:26:27Web Name: IMVEXXY® (estradiol vaginal inserts) - Official Physician Website
WebSite: http://www.imvexxyhcp.com
ID:318960
Keywords:
estradiol,vaginal,IMVEXXY,regDescription:
Vaginal
Atrophy Treatment
Experience Efficacy Safety &
PK Data Samples
& Savings
Discover A Treatment Experience With
Simplicity At Its Core1
The only ultra-low-dose vaginal estradiol available in both 4-mcg and 10-mcg doses1,2
Proven efficacy with early onset of action at 2 weeks1,3*
Applicator-free and mess-free administration1,3
*Secondary endpoint from a 12-week clinical trial.3
IMVEXXY offers an elegant design that fits into her life
Treatment Experience Demonstrated Efficacy Safety Profile Patient SavingsIMVEXXY is a vaginal estrogen treatment option for moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Vulvar and vaginal atrophy may also be known as vulvovaginal atrophy, atrophic vaginitis, or vaginal atrophy.4
IMVEXXY is a bio-identical,* softgel vaginal insert that offers an applicator-free experience with mess-free administration, no dose preparation, and any time of day dosing, which may help support patient compliance. IMVEXXY is the only ultra-low-dose vaginal estradiol available in both 4-mcg and 10-mcg doses.1,2,5,6
*The relevance of risks associated with the use of synthetic hormones compared to bio-identical hormones is not known but cannot be excluded.
References:
1. Imvexxy [package insert]. Boca Raton, FL: TherapeuticsMD, Inc; 2021.
2. Data on file. Vaginal Estrogen PIs.
3. Constantine GD, Simon JA, Pickar JH, et al. The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy. Menopause. 2017;24(4):409-416.
4. Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Menopause. 2014;21(10):1063-1068.
5. Data on file. Clinical Study Report, Protocol No. TXV14-01.
6. Position Statement - Bioidentical Hormones. Endocrine Society. 2006.
Important Safety Information
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER
See full prescribing information for complete boxed warning.
Estrogen-Alone Therapy
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) 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 Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementiaEstrogen Plus Progestin Therapy
The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI) The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementiaThe WHI estrogen-alone and estrogen plus progestin substudies evaluated only daily oral conjugated estrogens (CE) [0.625 mg] and medroxyprogesterone acetate (MPA) [2.5 mg]. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE and MPA doses, other routes of administration, or other estrogen-alone or estrogen plus progestogen products is not known, and cannot be definitively excluded or determined.
Contraindications
IMVEXXY (estradiol vaginal inserts) is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to IMVEXXY; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
Warning and Precautions
Risks from systemic absorption. IMVEXXY is intended only for vaginal administration. Systemic absorption may occur with the use of IMVEXXY. Cardiovascular disorders, malignant neoplasms, and probable dementia. Please refer to Boxed Warning for endometrial cancer, cardiovascular disorders, probable dementia, and breast cancer. The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation. The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown. Other warnings include: gallbladder disease; severe hypercalcemia, loss of vision, elevated blood pressure, severe hypertriglyceridemia, cholestatic jaundice, fluid retention, and hypocalcemia in women with hypoparathyroidism. Estrogen therapy may exacerbate: hypothyroidism, endometriosis, hereditary angioedema, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas, and should be used with caution in women with these conditions. Women on thyroid replacement therapy should have their thyroid function monitored.Adverse Reactions
The most common adverse reaction with IMVEXXY (≥3%) was headache.Indication
IMVEXXY (estradiol vaginal inserts) is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING.
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