Estrogen and Atrophic Vaginitis During Menopause

From the time puberty starts, women begin producing much more estrogen. During the aging process, estrogen production slows and can cause physical changes. This can cause physical symptoms including vaginal discomfort, dryness, itching, and burning.

There are three phases of menopause: perimenopause, menopause, and postmenopause.

There are three phases of menopause. Perimenopause includes the years leading up to menopause. It is a transition phase that can last 6 years or more. Menopause is medically confirmed after 1 year of missed periods. The phase after menopause is called postmenopause. As women live longer, it is possible that they will spend at least one-third of their lives with less estrogen in the vagina.

As estrogen production slows down, the symptoms of menopause can begin. This is a natural part of aging, usually occurring between the ages of 40 and 58, and can involve vaginal symptoms.

Vagifem® Indications and Usage

Vagifem® is used after menopause to treat menopausal changes in and around the vagina.

Vagifem® Important Safety Information

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-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 age 65 years or older
Do not use estrogens with progestins to prevent heart disease, heart attack, or dementia
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
Using estrogens with progestin may increase your chance of getting dementia, based on a study of women 65 years and older
You and your healthcare provider should talk regularly about whether you still need treatment with 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, are allergic to Vagifem® or any of its ingredients, or think you may be pregnant.

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® included: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.

Estrogens should be used at the lowest possible dose for your treatment only as long as needed.

Please click here for Prescribing Information and FDA-Approved Patient Labeling.

Vagifem® is only available by prescription. For more information about Vagifem®, please call 1-866-668-6336.
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.