"March 14, 2013 -- Hormone replacement therapy is the most effective treatment for symptoms like hot flashes, and the benefits are likely to outweigh the risks, major medical societies say.
The statement was published in the April issue "...
(estradiol transdermal spray)
Instructions for use.
Read this PATIENT INFORMATION before you start using Evamist and read the patient information each time you refill your Evamist prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms and their treatment.
- Patient Information:
Details with Side Effects
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).
What is Evamist?
Evamist is a medicine that contains estradiol (an estrogen hormone). When applied to the skin, estradiol is absorbed through the skin into the bloodstream.
What is Evamist used for?
Evamist is used after menopause to:
- Reduce moderate to severe hot flashes
Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, a woman's ovaries are removed during an operation that causes “surgical menopause.”
When the estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogen treatment. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Evamist.
Who should not use Evamist?
Do not start using Evamist if you:
- Have unusual vaginal bleeding
- Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Evamist.
- Had a stroke or heart attack in the past year
- Currently have or have had blood clots
- Currently have or have had liver problems
- Are allergic to any of the ingredients in Evamist
See the list of ingredients in Evamist at the end of this leaflet
- Think you may be pregnant
Tell your healthcare provider:
- If you are breastfeeding
The hormone in Evamist can pass into your breast milk.
- About all your medical problems
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- About all the medicines you take
- If you are going to have surgery or will be on bed rest
You may need to stop taking estrogens.
How should I use Evamist?
Evamist is available in a spray applicator that delivers a measured amount
of estradiol to the skin with each spray (see Illustration 1).
It is important that you read and follow these directions on how to use Evamist properly.
1. Before using the applicator for the first time, it must be primed. With
the cover on, and the applicator upright, fully depress the applicator three
times with your thumb or index finger. This is called priming (see Illustration
2). After priming, the applicator is ready to use. The applicator should
be primed only once when you first start using a new applicator. DO NOT PRIME
THE APPLICATOR BEFORE EACH DAY'S DOSE.
2. Apply Evamist once a day each morning.
3. Apply your daily dose of Evamist to clean, dry, unbroken skin on the inside
of the forearm between the elbow and the wrist (see Illustration 3).
Do not apply Evamist to other areas of the skin. To apply the dose, remove the
plastic cover, hold the applicator upright and rest the plastic cone flat against
the skin. You may need to change the position of your arm or the position of
the cone on your arm so that the cone is flat against your skin and there are
no gaps between the cone and your skin. Depress the pump fully once.
4. If your healthcare provider tells you to increase the dose to 2 or 3 sprays,
you should move the cone before applying the second or third spray to an area
of the skin next to but not touching the area of the previous spray (see Illustration
5. Always place the protective cover back on the cone of the applicator.
6. Do not rub Evamist spray into your skin. Evamist spray should dry on your skin for at least 2 minutes before you get dressed, and at least one hour before you wash your skin. After you spray Evamist 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.
7. 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).
8. If another person accidentally touches the area of your skin where you sprayed Evamist, tell that person to wash the area of their skin with soap and water right away. The longer the Evamist stays on the skin before it is washed off, the greater the chance the estrogen hormone may be absorbed.
9. 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.
- Talk to your healthcare provider about the correct use of Evamist when around children.
- Stop using Evamist and call your healthcare provider right away if you
see any signs and symptoms (breast development or other sexual changes) 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 you healthcare provider to discuss other treatments for your menopause symptoms if accidental exposure to Evamist cannot be avoided.
10. Evamist 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.
11. Never apply Evamist directly to the breast or in or around the vagina.
Start at the lowest dose (1 spray) and talk to your healthcare provider about how well that dose is working for you. Treatment with estrogen should be started at the lowest dose possible, and used only for as long as needed to provide relief of moderate to severe hot flashes associated with menopause. You and your healthcare provider should talk regularly (every 3-6 months) about the dose you are taking and whether you still need treatment with Evamist.
The Evamist applicator contains enough product to allow for initial priming of the pump with three sprays plus application for 75 sprays. The product will last approximately 75 days if you use 1 spray each day, 37 days if you use 2 sprays each day and 25 days if you use 3 sprays each day.
Do not use this applicator for more than 75 sprays even though the bottle may not be completely empty.
Evamist 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 should not be used after the expiration date. When the applicator has been used for 75 sprays you can discard it in normal household waste.
What should I do if I miss a dose?
If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed and resume your normal dosing the next day.
What should I avoid while using Evamist?
- Do not allow others to make contact with the area of skin where you applied the spray.
- Evamist contains alcohol and alcohol-based liquids are flammable. Avoid fire, flame or smoking until the spray has dried.
- Do not let pets lick or touch your arm where you sprayed Evamist, especially small pets. Evamist may harm them. Cover your skin with clothing where you sprayed Evamist if you think a pet could come in contact with that area of your skin.
What are the possible side effects of estrogens?
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious but less common side effects include:
- Breast cancer
- Cancer of the uterus
- Heart attack
- Blood clots
- Gallbladder disease
- Ovarian cancer
- High blood pressure
- Liver problems
- High blood sugar
- Enlargement of benign tumors of the uterus (“fibroids”)
Some of the warning signs of these serious side effects include:
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.
Less serious but common side effects include:
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach/abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
These are not all of the possible side effects of Evamist. For more information, ask your healthcare provider or pharmacist.
What can I do to lower my chances of a serious side effect with Evamist?
- Talk with your healthcare provider regularly about whether you should continue using Evamist.
- If you have a uterus, talk with your healthcare provider about whether the addition of a progestin (a different prescribed hormone medication) is right for you. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
- See your healthcare provider right away if you get vaginal bleeding while using Evamist.
- Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you otherwise. If members of your family have had breast cancer or if you have had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease.
General information about the safe and effective use of Evamist.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Evamist for conditions for which it was not prescribed. Do not give Evamist to other people, even if they have the same symptoms you have. It may harm them.
Keep Evamist out of the reach of children.
This leaflet provides a summary of the most important information about Evamist. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Evamist that is written for health professionals.
You can get more information by calling the toll free number (877) 567-7676.
What are the ingredients in Evamist?
Active ingredient: estradiol (an estrogen hormone)
Inactive ingredients: octisalate (a common active ingredient in some sunscreens used to enhance skin penetration), alcohol (to dissolve the drug)
Last reviewed on RxList: 11/10/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Evamist Information
Evamist - User Reviews
Evamist User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.