Elestrin estradiol gel 0.06%

About
Elestrin

Facts About Elestrin

Low dose of estrogen

  • Available in two low-dose options.1 Dosing is flexible and can be adjusted with guidance from your healthcare provider
  • Because it is administered transdermally (through the skin), Elestrin does not need to pass through the liver before entering the bloodstream. As a result, Elestrin is available using relatively low amounts of estrogen1-3
  • Elestrin comes in a metered-dose pump, so you can be sure of using the right amount of gel every time
  • Associations such as the US Food and Drug Administration (FDA), North American Menopause Society (NAMS), and American College of Obstetrics and Gynecologists (ACOG) advise that hormone therapy should be given at the lowest dose that helps, for the shortest time needed5-7

FDA-approved

  • As Elestrin is an FDA-approved prescription product, its safety and efficacy have been studied in a clinical trial
  • Elestrin is manufactured and regulated according to strict standards for prescription medicine

Most common side effects with Elestrin

  • The most frequently reported adverse events in a clinical trial with Elestrin were:4
    • Nose-throat irritation
    • Breast tenderness
    • Upper respiratory tract infection
    • Abnormal vaginal bleeding

These are not all the possible side effects of Elestrin.1 In general, patients should be started on the lowest possible dose that helps. See risk information, including black box warning, at the bottom of this page. For more information, ask your healthcare provider or pharmacist or view the Patient Information for Elestrin.

Who Should Not Take Elestrin

Estrogen products, including Elestrin, should not be used if you:4

  • 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 pregnant

All estrogen therapy has risks. Please see important safety information at the bottom of this page.

Talk to your healthcare provider about whether Elestrin may be right for you.

You are encouraged to report negative side effects of prescription drugs to the FDA by visiting www.fda.gov/medwatch.

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. 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.
  2. Carroll N. A review of transdermal non-patch estrogen therapy for the management of menopausal symptoms. J Womens Health. 2010;19(1):47-55.
  3. Hirvonen E, Cacciatore B, Wahlstrom T, et al. Effects of transdermal oestrogen therapy in postmenopausal women: a comparative study of an oestradiol gel and an oestradiol delivering patch. BJOG 1997. 104 (suppl16):26-31.
  4. Elestrin (estradiol gel) full Prescribing Information. Azur Pharma, Philadelphia, PA, July 2010.
  5. US Food and Drug Administration Web site. Available at: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm. Accessed July 20, 2010.
  6. American College of Obstetrics and Gynecology Web site. Available at: http://www.acog.org/from_home/publications/press_releases/nr10-01-04.cfm. Accessed July 20, 2010.
  7. North American Menopause Society updates guidelines on postmenopausal hormone therapy. Available at: http://cme.medscape.com/viewarticle/576970. Accessed July 20, 2010.