Evamist.com – Safety Update

Evamist was approved by the U.S. Food and Drug Administration in 2007 for the treatment of moderate-to-severe hot flashes due to menopause.

As with all prescription medications, it is important patients understand how to use their medication. Ther-Rx would like to notify you about important changes to the Evamist prescribing information that help educate patients and prescribers on how to use Evamist appropriately.

The boxed warning has been updated to include a warning of the potential of adverse effects in children who may be unintentionally exposed to Evamist through skin contact with women using the product. The prescribing information also emphasizes the importance of strict adherence to precautions and dosing information to minimize the potential for secondary exposure to others. Click here to read the full patient information leaflet, which includes complete dosing information.

The potential adverse effects resulting from unintentional secondary exposure to Evamist include signs of puberty that may not be expected (for example, breast budding). In most cases, the condition resolved with removal of Evamist exposure. Women should ensure that children do not come into contact with the site(s) where Evamist is applied. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Caution should be exercised for women using Evamist who may have contact with young children. Although Evamist can continue to be used safely for many women, patients should always discuss treatment options with their own personal healthcare provider.

Similar caution should be exercised for women using Evamist who may have contact with pets. Pets should not lick or come into contact with the site where Evamist is applied.

For more information, patients and healthcare providers can call the Ther-Rx Medical Affairs line at 1-877-567-7676, extension 3790.

Important Safety Information

What is the most important information I should know about Evamist (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 Evamist. 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 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 progestins 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 Evamist
•	The estrogen in Evamist spray can transfer from the area of skin where it was sprayed to other people. Do not allow others, especially children, to come into contact with the area of your skin where you sprayed Evamist. Young children who are accidentally exposed to estrogen through contact with women using Evamist may show signs of puberty that are not expected (for example, breast budding)

Evamist is an estrogen hormone used after menopause to reduce moderate to severe hot flashes.

Evamist should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the past year; currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.

The most common side effects that may occur with Evamist are headache, breast tenderness, the common cold, nipple pain, back pain, nausea, and joint pain.

Please see full patient information for Evamist.

Please see full prescribing information for Evamist, including boxed warnings.

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.