Evamist

Generic Name: estradiol topical (for use on skin) (ess tra DYE ol TOP ik al)
Brand Names: Divigel, Elestrin Pump, Estrasorb, Estrogel pump, Evamist

What is Evamist?

Evamist is a transdermal spray containing estradiol. Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body. Each spray delivers 90 mcL which contains 1.53 mg of estradiol.

Evamist is used for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.

Evamist may also be used for purposes not listed in this medication guide.

Important information

You should not use Evamist if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), a bleeding or blood-clotting disorder, liver disease, abnormal vaginal bleeding, history of an allergic reaction to estradiol topical, or a hormone-related cancer such as breast or uterine cancer.

Evamist can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Do not use Evamist if you are breast-feeding a baby. Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with Evamist or with skin where the medicine was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts. Children should avoid coming into contact with skin areas where you have applied Evamist. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply Evamist.

Slideshow: Flashback: FDA Drug Approvals 2013

Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.

Talk with your doctor about your individual risks before using Evamist long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Before using Evamist

Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.

Talk with your doctor about your individual risks before using Evamist long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

You should not use Evamist if you have:

  • a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

  • liver disease;

  • a bleeding or blood-clotting disorder;

  • unusual vaginal bleeding that has not been checked by a doctor;

  • any type of breast, uterine, or hormone-dependent cancer; or

  • if you have ever had an allergic reaction to estradiol topical.

To make sure you can safely use Evamist, tell your doctor if you have any of these other conditions:

  • high blood pressure, angina, or heart disease;

  • high cholesterol or triglycerides;

  • kidney disease;

  • asthma;

  • hereditary angioedema;

  • epilepsy or other seizure disorder;

  • migraines;

  • endometriosis;

  • diabetes;

  • a thyroid disorder;

  • depression;

  • porphyria;

  • lupus;

  • gallbladder disease; or

  • low levels of calcium in your blood.

FDA pregnancy category X. Evamist can cause birth defects. Do not use Evamist if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using Evamist. Estradiol can pass into breast milk and may harm a nursing baby. Evamist may also slow breast milk production. Do not use if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using Evamist.

How should I use Evamist?

Use Evamist exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Evamist comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply Evamist only to clean, dry, unbroken skin. Do not apply to skin that is red or irritated. Never apply Evamist to the breasts.

To use Evamist topical spray:

  • Apply the Evamist spray to the skin on the inside of your forearm, just below the elbow. Use the spray at the same time each day.

  • You will need to prime the pump before using it for the first time. To prime the pump, leave the cover on, hold the bottle in an upright position, and press the pump completely down 3 times. The pump is now ready for use.

  • Place the cone of the spray applicator directly to your skin and hold the pump upright. Press the pump firmly and fully one time only. If your doctor has prescribed more than one spray, choose a different place on your inside forearm for the second spray. Use only the number of sprays your doctor has recommended.

  • Do not rub the spray in, but allow it to dry on your skin for at least 2 minutes before you dress. Do not wash your arm for at least 30 minutes after applying the spray.

Avoid allowing other people to get Evamist on their skin. If this happens, wash the area thoroughly with soap and water. Children should avoid coming into contact with skin areas where you have applied Evamist. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Evamist.

Store Evamist at room temperature away from moisture and heat.

What happens if I miss a dose?

If you are less than 12 hours late in using Evamist, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, breast tenderness, drowsiness, and vaginal bleeding.

What should I avoid?

Do not apply sunscreen to your skin at the same time you apply Evamist. Avoid getting this medication in your eyes, and rinse thoroughly with water if this does happen.

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

Evamist side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Evamist: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Evamist and call your doctor at once if you have a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;

  • pain, swelling, warmth, or redness in one or both legs;

  • abnormal vaginal bleeding;

  • pain, swelling, or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes); or

  • a lump in your breast.

Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where Evamist was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

Less serious Evamist side effects may include:

  • nausea, vomiting, loss of appetite;

  • swollen breasts;

  • acne or skin color changes;

  • vaginal pain, dryness, or discomfort, decreased sex drive, or difficulty having an orgasm;

  • swelling, weight gain;

  • migraine headaches, dizziness, depression; or

  • break-through bleeding, vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Evamist?

Tell your doctor about all other medications you use, especially:

  • St. John's wort;

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • ritonavir (Norvir, Kaletra);

  • carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Luminal, Solfoton);

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or rifampin (Rifadin, Rifater, Rifamate, Rimactane).

  • an antifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or itraconazole (Sporanox).

This list is not complete and other drugs may interact with Evamist. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Evamist.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Evamist only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 7.01. Revision Date: 2012-06-13, 1:50:54 PM.

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