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
IMVEXXY 10 mcg package.

Meet IMVEXXY

Available in both 4 mcg and 10 mcg, IMVEXXY is a softgel estradiol vaginal
insert that relieves moderate to severe painful sex due to menopause.1,2
Fast acting3
Low and ultra-low doses1,2
Mess-free administration1

IMVEXXY gets busy so you can too

IMVEXXY tackles symptoms at the source so that you can get back to comfortable sex.1,3

In a study of postmenopausal women who used IMVEXXY for 12 weeks, IMVEXXY was shown to significantly reduce moderate to severe dyspareunia in as little as 2 weeks1,3

While IMVEXXY was studied over the course of 12 weeks, your healthcare provider may recommend that you continue with treatment to maintain vaginal health for relief from painful sex. IMVEXXY should be taken at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks.

Placed right where the magic happens

IMVEXXY is designed to stay in place as it rapidly dissolves, keeping things both mess free and stress free.1,4 Simply1:
1
Hold IMVEXXY by the
larger end.
2
Place it 2 inches into the vagina.
That’s it.

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

IMVEXXY side effects

Please review the Full Prescribing Information, including BOXED WARNING, for the risk information about IMVEXXY. The most common side effect of IMVEXXY is headache.1 Learn more about any potential side effects here.

Estrogen that matches your own

The estrogen in IMVEXXY is bioidentical* estradiol. That means it is chemically the same as the estradiol produced by your very own body.1,5 Because chemistry is important—and not just in the bedroom.
*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.
A woman stands among the crowd at a concert and throws her hands up to the music.

Ready to get IMVEXXY?

Get IMVEXXY

References: 1. IMVEXXY [package insert]. Raleigh, NC: Mayne Pharma; 2023. 2. Data on file. Mayne Pharma. Post-marketing Noninterventional Study report: IMVEXXY® PMR3483-1. 3. 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. 4. 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. 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