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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.
IMPORTANT RISK INFORMATION
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 or with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
- Using estrogen-alone or with progestin may increase your chances of getting strokes or blood clots.
- Using estrogen-alone or with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
- Using estrogens with progestins may increase your chances of getting heart attacks or breast cancer.
- Talk to your doctor regularly about whether you still need treatment with IMVEXXY.
DO NOT USE IF YOU
- have unusual vaginal bleeding.
- 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.
- have been diagnosed with a bleeding disorder.
- are allergic to IMVEXXY or any of its ingredients.
- think you may be pregnant.
Tell your healthcare provider about all of your medical conditions, including if you:
- have any unusual vaginal bleeding.
- 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 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
- breast tenderness or pain
- nausea and vomiting
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 at imvexxy.com/pi.pdf.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088. You may also report side effects to TherapeuticsMD at 1-888-228-0150.
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