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.
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
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.
The most common adverse reaction with IMVEXXY (incidence ≥3 percent) and greater than placebo was headache.