For the treatment of moderate-to-severe vasomotor symptoms due to menopause
Full Prescribing Information

Each Evamist® (estradiol transdermal spray) applicator contains enough medication to allow for initial priming of the pump with 3 sprays and application of 56 sprays, providing the precise amount of medicine each time the applicator is used.

The product will last approximately 56 days if you use 1 spray each day, 28 days if you use 2 sprays each day, and 18 days if you use 3 sprays each day. Do not use this applicator for more than 56 sprays even though the bottle may not be completely empty.

Click the video to view instructions on every day dosing with Evamist®.


Steps to applying Evamist.

Before using the Evamist® (estradiol transdermal spray) applicator for the first time, it must be primed. With the cover on and the applicator upright, fully depress the applicator 3 times with your thumb or index finger. After priming, the applicator is ready to use. DO NOT PRIME THE APPLICATOR BEFORE EACH DAY’S DOSE.


Do not apply Evamist® (estradiol transdermal spray) to other areas of the skin. Never apply Evamist directly to the breast or in or around the vagina.


Take steps to avoid unintended exposure to estrogen.

After you spray Evamist® (estradiol transdermal spray) on your skin, do not allow other people and pets to make contact with the area of skin where you applied the spray after application. Cover your skin with clothing where you sprayed Evamist if you think another person will come in contact with that area of skin. If you get Evamist spray on another area of your skin like your hands, wash that area of your skin with soap and water right away.

The estrogen in Evamist® (estradiol transdermal 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).

If another person accidentally touches the area of your skin where you sprayed Evamist® (estradiol transdermal spray), tell that person to wash the area of their skin with soap and water right away. The longer Evamist stays on the skin before it is washed off, the greater the chance the estrogen hormone may be absorbed.

If a child under your care unexpectedly starts to develop breasts or has other sexual changes:

  • Have the child checked right away by their healthcare provider
  • Stop using Evamist® (estradiol transdermal spray) and call your healthcare provider right away if you see any signs and symptoms in a child that may have occurred through accidental exposure to Evamist. In most cases the child’s breasts will go back to normal when they are no longer exposed to Evamist.
  • Talk to your healthcare provider about the correct use of Evamist when around children
  • Talk to your healthcare provider to discuss other treatments for your menopause symptoms if accidental exposure to Evamist cannot be avoided

Evamist® (estradiol transdermal spray) contains alcohol, and alcohol-based liquids are flammable. Avoid fire, flame, or smoking when using Evamist until the spray has dried. Do not apply Evamist while standing near a flame.

Evamist® (estradiol transdermal spray) can be stored in a clean, dry place at room temperature (15° to 30°C or 59° to 86°F) and does not need refrigeration. Do not freeze.

Evamist® (estradiol transdermal spray) should not be used after the expiration date.

EXPAND

Important Safety Information for EVAMIST (estradiol transdermal spray)

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 womb. Your healthcare provider should check any unusual vaginal bleeding to find the cause.
  • Do not use estrogen alone or with progestins to prevent heart disease, heart attacks, strokes or dementia (decline in brain function).
  • Using estrogen-alone or with progestins may increase your chances of getting strokes, blood clots, or dementia.
  • Using estrogens with progestins may increase your chances of getting heart attacks or breast cancer.
  • 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).
  • You and your healthcare provider should talk regularly about whether you still need treatment with EVAMIST.

Do not start using EVAMIST if you have unusual vaginal bleeding; currently have or have had certain cancers; 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 EVAMIST or any of its ingredients; or think you may be pregnant

Before you use EVAMIST, tell your healthcare provider if you have any unusual vaginal bleeding; have any other medical conditions; are going to have surgery or will be on bed rest; are breast feeding

Tell your healthcare provider about all medicines you take. Some medicines may affect how EVAMIST works. EVAMIST may also affect how your other medicines work.

Talk to your healthcare provider about other treatments for your menopause symptoms if accidental exposure to EVAMIST cannot be avoided.

EVAMIST contains alcohol, which is flammable. Avoid fire, flame, or smoking until the area of your skin where you have applied EVAMIST has dried.

The most common s side effects associated with EVAMIST are headache, breast tenderness, nipple pain, back pain and nasopharyngitis.

These are not all the possible side effects of EVAMIST. For more information, refer to the Patient Information section of the full Prescribing Information or ask your healthcare provider or pharmacist.