Important Safety Information

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

The WHI estrogen-alone and estrogen plus progestin substudies evaluated only daily oral conjugated estrogens (CE) [0.625 mg] and medroxyprogesterone acetate (MPA) [2.5 mg]. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE and MPA doses, other routes of administration, or other estrogen-alone or estrogen plus progestogen products is not known, and cannot be definitively excluded or determined.

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 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

  • 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 hypoparathyroidism.
  • 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.

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