For moderate to severe vasomotor
symptoms due to menopause


Learn about Elestrin

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.