Elestrin estradiol gel 0.06%

About
Elestrin

Frequently Asked Questions About Elestrin

What is Elestrin?

Elestrin is a medicine that's used to relieve moderate-to-severe hot flashes. It's a colorless gel that contains an estrogen hormone (estradiol), which is absorbed through the skin into the bloodstream.1

What is Elestrin used for?

Elestrin is used after menopause to reduce moderate-to-severe hot flashes. During menopause, a woman's ovaries stop producing eggs, her body produces lower levels of estrogen and other hormones, and menstruation becomes less frequent, eventually stopping altogether. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. A woman who has had both ovaries surgically removed may begin menopause earlier.

When the estrogen levels begin dropping, some women develop 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 estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Elestrin.1

Who shouldn't use Elestrin?

Do not use Elestrin, if you:

  • Have unusual vaginal bleeding
  • Currently have or have had certain cancers
  • 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 Elestrin or any of its ingredients
  • Think you may be pregnant1
  • For additional important risk information, please see below on this page for black box warning, precautions, adverse reactions and contraindications. For full prescribing information about Elestrin, please see Prescribing Information

What are the ingredients in Elestrin?

The active ingredient in Elestrin is estradiol, a form of estrogen. Learn about the inactive ingredients in Elestrin by viewing the patient information here1

How should I use Elestrin?

  1. Clean and dry your skin
  2. Apply 1 or 2 pumps as directed by your healthcare provider
  3. Rub into your upper arm; allow 5 minutes to dry
  4. Wash your hands immediately after applying Elestrin

Be sure to start at the lowest dose as directed by your healthcare provider.1

For more details on how to use Elestrin, click here.

What should I do if someone is exposed to Elestrin?

If someone else is exposed to Elestrin by direct contact with the gel, that person should wash the area of contact with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some of the estrogen hormone. This is especially important for men and children and pets.1

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.1

What are the common side effects of Elestrin?

  • The most frequently reported adverse events in a clinical trial with Elestrin were:1
    • Nose-throat irritation
    • Breast tenderness
    • Upper respiratory tract infection
    • Abnormal vaginal bleeding

These are not all the possible side effects of Elestrin.2 See additional risk information, including black box warning, at bottom of this page. For more information, ask your healthcare provider or pharmacist or view the Patient Information for Elestrin therapy.

You are encouraged to report negative side effects of prescription drugs to the US Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch

How much does Elestrin cost?

When you use the coupon for Elestrin, you pay no more than $25 for each Elestrin prescription.

What makes Elestrin different?

Elestrin has a patented Advanced Transdermal Delivery™ (ATD) system. This system is a novel way to efficiently absorb low-dose estrogen2 through the skin and into the bloodstream, which promotes a significant reduction in the frequency and severity of hot flashes associated with menopause.3

Is Elestrin a natural therapy?

Elestrin contains 17 beta-estradiol, a form of estrogen that was originally harvested from a plant source and is identical to the natural hormone produced in your body.1 It is synthetically developed in a medical laboratory.

How do I apply Elestrin?

Elestrin is a colorless, non-staining, quick-drying gel that you spread on a small area of your upper arm once a day. For more information on how to apply Elestrin, click here.

Indication

Elestrin is indicated for the treatment of moderate-to-severe hot flashes and night sweats associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia (decline in memory or thinking skills). Estrogen and progestin therapy has shown an increased risk of breast cancer, heart attack, and blood clots. Estrogen therapy, with or without progestins, increases the risk of stroke and dementia. Estrogen therapy alone increases the risk of cancer of the uterus (womb).

Elestrin 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 recent past; 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 frequently reported adverse events in clinical trials were nose and throat irritation, breast tenderness, upper respiratory tract infection, and irregular menstrual bleeding.

You and your healthcare provider should discuss whether Elestrin is right for you or whether you still need treatment with Elestrin.

Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Please see full Prescribing Information, including Boxed Warning and Patient Information Sheet.

You are encouraged to report negative side effects of prescription drugs to the FDA (Food and Drug Administration).
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-890-3098.

References

  1. Elestrin (estradiol gel) full Prescribing Information. Azur Pharma, Philadelphia, PA, July 2010.
  2. Simon JA, Bouchard C, Waldbaum A, et al. Low dose of transdermal estradiol gel for treatment of symptomatic postmenopausal women. Obstet Gynecol. 2007;109:588-96.
  3. Data on file. Jazz Pharmaceuticals