Evamist

Evamist is a prescription medication used to treat symptoms of menopause including hot flashes.

Evamist contains estradiol which is a form of the hormone estrogen. It replaces estrogen that is not naturally produced by the ovaries.

This medication comes is available as a transdermal spray. It is usually applied once a day, each morning. 

Common side effects of Evamist include headache, breast tenderness and nipple pain.

Evamist is a prescription medication used to treat symptoms of menopause including hot flashes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Ther-RX Corporation

Serious side effects have been reported Evamist. See the “Evamist Precautions” section.

Common side effects of Evamist include the following:

• headache
• breast pain
• nipple pain
• back pain
• runny nose
• irregular vaginal bleeding or spotting
• stomach or abdominal cramps, bloating
• nausea and vomiting
• hair loss
• fluid retention
• vaginal yeast infection

This is not a complete list of Evamist side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Amiodarone (Cordarone, Pacerone)
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Aprepitant (Emend)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Clarithromycin (Biaxin)
• Cyclosporine (Neoral, Sandimmune)
• Dexamethasone (Decadron, Dexpak)
• Diltiazem (Cardizem, Dilacor, Tiazac, others)
• Erythromycin (E.E.S, Erythrocin)
• Fluoxetine (Prozac, Sarafem)
• Fluvoxamine (Luvox)
• Griseofulvin (Fulvicin, Grifulvin, Gris-PEG)
• Lovastatin (Altocor, Mevacor)
• Medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin 
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of Evamist drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Evamist including the following:

• bulging eyes
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Do not use Evamist if you:

• are allergic to Evamist or have known angioedema with Evamist 
• have abnormal vaginal bleeding
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• currently have or have a history of blood clots
• have had a stroke or heart attack
• have been diagnosed with a bleeding disorder
• have liver disease
• are pregnant or possibly pregnant

Grapefruit and grapefruit juice may interact with Evamist and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before using Evamist, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are going to have surgery or will be on bed rest
• are allergic to Evamist or to any of its ingredients
• have abnormal vaginal bleeding
• currently have or have had certain cancers
• currently have or have a history of blood clots
• have had a stroke or heart attack
• have been diagnosed with a bleeding disorder
• have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Evamist should not be used during pregnancy. There appears to be little or no increased risk of birth defects in children born to women who inadvertently used estrogens during early pregnancy. Talk to your doctor right away if you become pregnant while using Evamist.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Estrogen has been detected in human breast milk. Estrogen can decrease the quality or quantity of breast milk. Evamist should not be used during lactation.

Use Evamist exactly as prescribed.

• Evamist is for skin use only.

• Apply Evamist at the same time each day.

• If you use sunscreen 1 hour after you use Evamist, it may reduce the amount of Evamist absorbed by your skin.

• The estrogen in Evamist spray can transfer from the area of skin where it was sprayed to other people or pets. Do not allow other people, especially children to come into contact with the area of your skin where you have sprayed Evamist.

• If another person accidentally touches the area of your skin where you have sprayed Evamist, that area of their skin should be washed with soap and water right away.

• Do not let pets lick or touch your arm where you have sprayed Evamist, especially small pets. Evamist may harm them. Cover your skin with clothing where you have sprayed Evamist if you think a pet could come in contact with that area of your skin.

  • If a pet accidentally comes in contact with the area of your skin where you have sprayed Evamist, the area of the pet’s skin should be washed with soap and water right away.

• Young children who are accidentally exposed to estrogen through contact with women using Evamist may show signs and symptoms of puberty that are not expected. Signs and symptoms in children of exposure to Evamist may include:

• breast budding or breast lumps
• other signs of abnormal sexual development

If a child shows signs and symptoms of accidental exposure to Evamist:

• have the child checked right away by their healthcare provider.
• stop using Evamist and call your healthcare provider right away.
• talk to your healthcare provider about the correct use of Evamist when around children.

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

You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Evamist.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Evamist (estradiol) transdermal spray for the treatment of menopause symptoms is one spray (1.53 mg) applied to the skin of the forearm once daily.

Your doctor may increase the dose to two or three sprays daily applied to the forearm. 

If you apply too much Evamist, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store at room temperature.

Keep this and all medicines out of the reach of children.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER, PROBABLE DEMENTIA, AND UNINTENTIONAL SECONDARY EXPOSURE TO ESTROGEN

Estrogen-Alone Therapy

• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
• The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
• The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Estrogen Plus Progestin Therapy

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia 
• The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) 
• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
• The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Unintentional Secondary Exposure

• Breast budding, breast masses, and gynecomastia have been reported in children following unintentional secondary exposure to Evamist