About Menopause and Elestrin

Menopause and your patients

Your patients look to you for help in making the right decisions about their healthcare, including treating symptoms of menopause.

At this time in their lives, patients may have many concerns and questions, and almost as many choices. Some of the issues you can help them understand include1:

About Elestrin
  • The uncomfortable symptoms that some women experience with menopause
  • That going through menopause is easier for some and harder for others
  • The many options available to help women through this transition

Knowing they have someone who can provide guidance and support during this time can mean a great deal. Also important is knowing they have options right at their fingertips.

About Elestrin

What is Elestrin?

Elestrin (estradiol gel) 0.06% is a treatment for moderate to severe vasomotor symptoms due to menopause.1

Elestrin (estradiol gel) 0.06% contains a form of exogenous estrogen sourced from plants.1

Exogenous estrogens are metabolized in the same manner as endogenous estrogens that occur naturally in the human body.1

Elestrin: Proven in a clinical trial to treat these menopausal symptoms

The safety and effectiveness of Elestrin was studied in a clinical trial of 484 postmenopausal women. That trial showed that Elestrin significantly reduced both the frequency and severity of hot flashes vs placebo at the end of the 12-week study.1

Reduction in frequency of hot flashes

The safety and effectivness of Elstrin was studied in a clinical trial of 484 menopausal women. This study met the primary endpoint, showing a statistically significant reduction in hot flush frequency by Elestrin compared to placebo by the end of the 12-week study.1

Administering Elestrin

Elestrin is a colorless, nonstaining gel that is applied once a day to the upper arm and shoulder using a metered-dose pump. There are two dosing options to choose from1:

  • 1 pump provides a low dose of Elestrin (0.52 mg of estradiol)
  • 2 pumps of Elestrin (1.04 mg of estradiol)

Patients should be started with the lowest effective dose of Elestrin, which is 1 pump per day (0.52 mg of estradiol).1

Subsequent dosing adjustments may be made based on individual patient response, which should be assessed periodically.1

References: 1. Elestrin [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2014.

More Important Safety Information

Warning: Endometrial cancer, cardiovascular disorders, breast cancer and probable dementia

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 risk of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI)
  • The WHI estrogen plus progestin study 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

ELESTRIN should not be used in women with any of the following conditions:

  • Undiagnosed abnormal genital bleeding
  • Known, suspected, or history of breast cancer
  • Known or suspected estrogen-dependent neoplasia
  • Active DVT, PE, or history of these conditions
  • Active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions
  • Known anaphylactic reaction or angioedema to ELESTRIN
  • Known liver impairment or disease
  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
  • Known or suspected pregnancy

Estrogens increase the risk of gallbladder disease.

Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or choloestatic jaundice occurs.

Monitor thyroid function in women on thyroid replacement therapy.

In a placebo-controlled trial that included a total of 484 postmenopausal women, the most common adverse reactions (≥ 5 percent) are breast tenderness, metrorrhagia, nasopharyngitis, and upper respiratory tract infections.

Inducers and/or inhibitors of CYP3A4 may effect estrogen drug metabolism.

Indications

ELESTRIN (estradiol gel) is used for the treatment of moderate to severe vasomotor symptoms due to menopause.

You are encouraged to report suspected adverse reactions. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional information, please see Full Prescribing Information including BOXED WARNING for Elestrin.