What Is Vagifem® 10 mcg?

Vagifem® 10 mcg, a local vaginal estrogen therapy, is used to treat menopausal changes in and around the vagina.

In clinical studies, Vagifem® 10 mcg reduced a combined score of the most bothersome symptoms of vaginal atrophy including vaginal dryness; pain and bleeding during intercourse; irritation, soreness, and itching in and around the vagina; and painful urination, at 12 weeks of treatment.

Vagifem® 10 mcg replaces estrogen lost within the vaginal tissues during menopause. It improved vaginal maturation index at 12 weeks, a measure of which types of cells are found in the vaginal lining. There was an increase in the percentage of superficial cells, which usually lessen in postmenopausal women. There was also a decrease in parabasal cells, which are typically more prominent with estrogen loss after menopause. It additionally improved the vaginal pH score at 12 weeks.

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.