IMPORTANT SAFETY INFORMATION

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

See full prescribing information for complete boxed warning.

Estrogen-Alone Therapy

Estrogen Plus Progestin Therapy

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 (for example stroke, MI) or a history of these conditions; known anaphylactic reaction, angioedema, or hypersensitivity to IMVEXXY; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Warning and Precautions

Adverse Reactions

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.

Full Safety Information Full Prescribing Information, Including BOXED WARNING
For US Residents Healthcare Professionals
Full Safety Information Full Prescribing Information, Including BOXED WARNING Healthcare Professionals

Good sex never gets old

But painful sex definitely does. When vulvar and vaginal atrophy (VVA), a symptom of menopause,
causes discomfort in the bedroom, IMVEXXY® offers fast relief at low and ultra-low doses.1,2
Meet IMVEXXY
An older woman beams up at her partner as he wraps a towel around her.

The biology of what’s happening in the bedroom…

…or not happening. Menopause is killing the mood, and it happens to more women than you think.3,4
Let's talk about it

The biology of what’s happening in the bedroom…

…or not happening. Menopause is killing the mood, and it happens to more women than you think.3,4
Let's talk about it
An older woman beams up at her partner as he wraps a towel around her.

Get IMVEXXY from home

Through UpScript, you can schedule a same-day telehealth appointment to see if IMVEXXY is right for you. Then, you can have it sent directly to your home or office. Because keeping things painless is kind of the whole point.

Get IMVEXXY

Relief with hormones

your body can recognize

IMVEXXY contains bioidentical* estrogen, which means it’s
chemically identical to what your body naturally produces.1,5
Get to know IMVEXXY
*A bioidentical hormone is one that has the exact same chemical and molecular structure as the hormones your body naturally produces.6 There are no data that suggest that bioidentical hormones are superior to synthetic hormones.

References: 1. IMVEXXY [package insert]. Raleigh, NC: Mayne Pharma; 2023. 2. Constantine GD, Simon JA, Pickar JH, et al; REJOICE Study Group. 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. 3. Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin Proc. 2010;85(1):87-94. 4. Nappi RE, Martini E, Cucinella L, et al. Addressing vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM) for healthy aging in women. Front Endocrinol (Lausanne). 2019;10:561. 5. Files JA, Ko MG, Pruthi S. Bioidentical hormone therapy. Mayo Clin Proc. 2011;86(7):673-680. 6. Stuenkel CA. Compounded bioidentical hormone therapy: new recommendations from the 2020 National Academies of Sciences, Engineering, and Medicine. Menopause. 2021;28(5):576-578.

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 dementia

Estrogen 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 dementia

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 (for example stroke, MI) or a history of these conditions; known anaphylactic reaction, angioedema, or hypersensitivity 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 hyperparathyroidism.
  • 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.

IMPORTANT SAFETY INFORMATION

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

See full prescribing information for complete boxed warning.

Estrogen-Alone Therapy

Estrogen Plus Progestin Therapy