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Important Risk 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.

MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT IMVEXXY(an estrogen hormone)

  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
  • Report any unusual vaginal bleeding right away while you are using IMVEXXY. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Using estrogen-alone may increase your chances of getting strokes or blood clots.
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older.
  • Do not use estrogens with progestogens to prevent heart disease, heart attacks, strokes or dementia.
  • Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age and older.
  • Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia. Because other products and doses have not been studied in the same way, it is not known how the use of IMVEXXY will affect your chances of having these conditions.
  • Talk to your healthcare provider regularly about whether you still need treatment with IMVEXXY.

Do not use if you

  • have unusual vaginal bleeding.
  • have been diagnosed with a bleeding disorder.
  • currently have or have had certain cancers.
  • currently have or have had blood clots.
  • had a stroke or heart attack.
  • currently have or have had liver problems.
  • are allergic to IMVEXXY or any of its ingredients.

Warnings

Tell your healthcare provider about all of your medical conditions, including if you:

  • have any unusual vaginal bleeding.
  • have any other medical conditions that may become worse while you are using IMVEXXY.
  • have asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • are going to have surgery or will be on bed rest. You may need to stop using IMVEXXY.
  • are pregnant or think you may be pregnant. Imvexxy is not for pregnant women.
  • are breast feeding.

Tell your healthcare provider about all the medicines you take.

IMVEXXY may affect the way other medicines work, and other medicines may affect how IMVEXXY works.

When using IMVEXXY you may have

  • headache
  • breast tenderness or pain
  • nausea and vomiting

USE

IMVEXXY (estradiol vaginal inserts) is a prescription medicine that contains an estrogen hormone in a vaginal insert. It is used after menopause to treat moderate to severe painful intercourse, a symptom of changes in and around your vagina, due to menopause.



The risk information provided here is not complete. To learn more, talk about IMVEXXY with your healthcare provider or pharmacist. The FDA-approved product labeling can be found here.



You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

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