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What is the most important information I should know about Evamist (an estrogen
hormone)?
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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.
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Do not use estrogen alone to prevent heart disease, heart
attacks, strokes or dementia (decline of brain function)
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Using estrogen alone may increase your chances of getting
strokes or blood clots
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Using estrogen alone may increase your chance of getting
dementia, based on a study of women 65 years or older
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Do not use estrogens with progestins to prevent heart
disease, heart attack or dementia
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Using estrogens with progestins may increase your chances
of getting heart attacks, strokes, breast cancer, or blood clots
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Using estrogens with progestins may increase your chance
of getting dementia, based on a study of women 65 years and older
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You and your healthcare provider should talk regularly
about whether you still need treatment with Evamist
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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)
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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.
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What is Evamist used for?
Evamist is used after menopause to:
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Reduce moderate to severe hot flashes
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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.
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Who should not use Evamist?
Do not start using Evamist if you:
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Have unusual vaginal bleeding
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Currently have or have had certain cancers
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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.
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Had a stroke or heart attack in the past year
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Currently have or have had blood clots
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Currently have or have had liver problems
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Are allergic to any of the ingredients in Evamist
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See the list of ingredients in Evamist at the end of this leaflet
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Think you may be pregnant
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Tell your healthcare provider:
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If you are breastfeeding
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The hormone in Evamist can pass into your breast milk.
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About all your medical problems
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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.
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About all the medicines you take
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This includes prescription and nonprescription medicines, vitamins, and herbal supplements.
Some medicines may affect how Evamist works. Evamist may also affect how your other
medicines work.
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If you are going to have surgery or will be on bed
rest
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You may need to stop taking estrogens.
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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).
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It is important that you read and follow these directions on how to use Evamist
properly.
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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.
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Apply Evamist once a day each morning.
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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.
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4.
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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 4).
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Always place the protective cover back on the cone of
the applicator.
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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.
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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).
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8.
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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.
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If a child under your care unexpectedly starts to develop
breasts or has other sexual changes:
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Have the child checked right away by their healthcare
provider.
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Talk to your healthcare provider about the correct
use of Evamist when around children.
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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.
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Talk to you healthcare provider to discuss other treatments
for your menopause symptoms if accidental exposure to Evamist cannot be avoided.
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10.
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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.
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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.
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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.
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What should I avoid while using Evamist?
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Do not allow others to make contact with the area of skin
where you applied the spray.
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Evamist contains alcohol and alcohol-based liquids are
flammable. Avoid fire, flame or smoking until the spray has dried.
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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.
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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:
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Breast cancer
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Cancer of the uterus
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Stroke
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Heart attack
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Blood clots
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Dementia
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Gallbladder disease
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Ovarian cancer
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High blood pressure
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Liver problems
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High blood sugar
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Enlargement of benign tumors of the uterus (“fibroids”)
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Some of the warning signs of these serious side effects include:
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Breast lumps
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Unusual vaginal bleeding
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Dizziness and faintness
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Changes in speech
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Severe headaches
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Chest pain
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Shortness of breath
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Pains in your legs
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Changes in vision
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Vomiting
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Yellowing of the skin, eyes or nail beds
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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:
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Headache
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Breast pain
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Irregular vaginal bleeding or spotting
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Stomach/abdominal cramps, bloating
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Nausea and vomiting
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Hair loss
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Fluid retention
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Vaginal yeast infection
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These are not all of the possible side effects of Evamist. For more information,
ask your healthcare provider or pharmacist.
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What can I do to lower my chances of a serious side effect with Evamist?
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Talk with your healthcare provider regularly about whether
you should continue using Evamist.
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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.
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See your healthcare provider right away if you get vaginal
bleeding while using Evamist.
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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.
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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.
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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.
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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)
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Important Safety Information
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What is the most important information I should know about Evamist (an estrogen
hormone)?
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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.
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Do not use estrogen alone to prevent heart disease, heart
attacks, strokes or dementia (decline of brain function)
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Using estrogen alone may increase your chances of getting
strokes or blood clots
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Using estrogen alone may increase your chance of getting
dementia, based on a study of women 65 years or older
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Do not use estrogens with progestins to prevent heart
disease, heart attack or dementia
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Using estrogens with progestins may increase your chances
of getting heart attacks, strokes, breast cancer, or blood clots
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Using estrogens with progestins may increase your chance
of getting dementia, based on a study of women 65 years and older
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You and your healthcare provider should talk regularly
about whether you still need treatment with Evamist
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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)
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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.
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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.
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