What is the most important information I should know about Vagifem® (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 Vagifem®. 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 the cause.
- Do not use estrogen with or without progestins 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 estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
- Using estrogens with or without progestins may increase your chance of getting dementia, based on a study of women age 65 years or older.
- You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem®.
Who should not use Vagifem®?
Do not start using Vagifem® if you currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. Also, do not start using Vagifem® if you have unusual vaginal bleeding, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to Vagifem® or any of its ingredients, or think you may be pregnant.
How should I use Vagifem®?
Estrogens should be used at the lowest dose possible for your treatment only as long as needed.
What are the possible side effects of Vagifem®?
Vagifem® is only used in the vagina; however, the risks associated with oral estrogens should be taken into account. The most commonly reported side effects of Vagifem® include: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.
Indications and Usage
What is Vagifem®?
Vagifem® (estradiol vaginal inserts) is used after menopause to treat menopausal changes in and around the vagina.
Please click here for Prescribing Information.
Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.
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
Talk to your health care provider and find out if Vagifem® 10 mcg is right for you.
