IMVEXXY Treatment Experience

In the treatment of moderate to severe dyspareunia, IMVEXXY offers

Simple Administration & Dosing

The only ultra-low-dose vaginal estradiol available in both 4-mcg and 10-mcg doses1,2

Mess-free administration—no applicator, dose preparation, or cleanup needed1,3

Convenient twice-weekly maintenance dosing, any time of day1

A softgel vaginal insert that dissolves within 6 hours4

Placed in the lower part of the vagina (~2 inches) to re-estrogenize the tissue in and around the area1

The freedom to enjoy everyday activities without interruption after insertion1

Straightforward Treatment Experience

Elegant packaging and easy-to-follow dosing instructions that support patient compliance

Starter Pack

To start using IMVEXXY, patients insert 1 softgel vaginal insert with their fingers into the vagina, smaller end up, once daily for 2 weeks.1

Maintenance Pack

For the maintenance dose of IMVEXXY, patients insert 1 softgel vaginal insert twice weekly every 3 to 4 days (for example, Monday and Thursday) for as long as they use IMVEXXY.1

IMVEXXY Offers Highly Rated Patient Acceptability5

88%
of women said IMVEXXY was easy to use5

80%
of women said IMVEXXY was easy to insert5

Patient Acceptability Survey

Patient Acceptability Survey

In the IMVEXXY phase 3 study, additional prespecified analyses were conducted, including a product acceptability questionnaire. Subjects (N=574) were asked to rate the acceptability of product administration by answering 5 questions at the end of study visit (week 12 or early termination).5

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.


Important Safety Information

Warning: endometrial cancer, cardiovascular disorders, breast cancer and probable dementia

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
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
  • 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

Estrogen Plus Progestin Therapy

  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
  • 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

Contraindications

  • IMVEXXY® 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

  • IMVEXXY is intended only for vaginal administration. Systemic absorption may occur with the use of IMVEXXY.
  • 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, severe hypertriglyceridemia or cholestatic jaundice.
  • Estrogen therapy may cause an exacerbation of 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 (incidence ≥3 percent) and greater than placebo was headache.

Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING.

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