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

Frequently asked questions

VVA is short for vulvar and vaginal atrophy, which is a result of your body producing less estrogen during and after menopause.1

The official medical term for painful sex is dyspareunia.2

There are several options to help relieve the symptoms of VVA. You can use over-the-counter treatments, but these typically only bring temporary relief. Lubricants are also an option, but these can be messy.1

With the help of a healthcare provider, you can decide which treatment plan works best for you.

IMVEXXY is specifically designed to treat symptoms at the source.1

IMVEXXY is a bioidentical,* softgel vaginal insert that relieves moderate to severe painful sex due to VVA, a symptom of menopause.2

No, IMVEXXY is not made from horse urine.3

The estrogen in IMVEXXY is manufactured estradiol. It is chemically identical to what’s produced naturally in the human body.2,4

IMVEXXY is designed to stay in place as it rapidly dissolves, keeping things both mess free and stress free.5 To use IMVEXXY, you simply2:

  1. Hold IMVEXXY by the larger end.
  2. Place it 2 inches into your vagina.

That’s it!

To see the full Instructions for Use for IMVEXXY, click here.

To start, you should use IMVEXXY once per day for 2 weeks. After that, insert IMVEXXY twice per week—for as long as you and your healthcare provider feel you need it. While you can use IMVEXXY at any time of day, you should use IMVEXXY around the same time each day.2

If menopause is disrupting your sex life, you should talk to your healthcare provider. Don’t worry—they’ve heard it all. There are a range of options available for getting IMVEXXY, regardless of your insurance or lack of insurance.

*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. Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin Proc. 2010;85(1):87-94. 2. IMVEXXY [package insert]. Raleigh, NC: Mayne Pharma; 2023. 3. Pattimakiel L, Thacker HL. Bioidentical hormone therapy: clarifying the misconceptions. Cleve Clin J Med. 2011;78(12):829-836.
4. Files JA, Ko MG, Pruthi S. Bioidentical hormone therapy. Mayo Clin Proc. 2011;86(7):673-680. 5. Kingsberg SA, Kroll R, Goldstein I, et al. Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR. Menopause. 2017;24(8):894-899. 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