Important Safety Information: ESTRACE® CREAM

IMPORTANT SAFETY INFORMATION

This Important Safety Information has been adapted from the Prescribing Information for ESTRACE® CREAM.

What are the most important things I need to know about vaginal estradiol?

 

  • BOXED WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

 

  • Using estrogen alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using vaginal estradiol cream. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogens alone or with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).
  • Using estrogens alone or with progestins may increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia.
  • You and your healthcare provider should talk regularly about whether you still need treatment with vaginal estradiol cream vaginal cream.

 

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (estrogen with progesterone). Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial biopsy when indicated, should be undertaken to rule out malignancy (uterine cancer) in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

 

Estrogens with or without progestins 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) - blood clots in the legs - in postmenopausal women with daily oral conjugated estrogens (CE) alone. The WHI estrogen-plus-progestin substudy reported increased risks of DVT, pulmonary embolism (blood clots in the lungs), stroke, and myocardial infarction (heart attack) in postmenopausal women with daily oral CE combined with medroxyprogesterone acetate (MPA). In the absence of comparable data, these risks should be assumed to be similar for other dosage forms of estrogens.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens-plus-medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen-alone therapy.

The WHI estrogen-plus-progestin substudy demonstrated an increased risk of invasive breast cancer.

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.

  • Estrogens increase the risk of gallbladder disease. Discontinue estrogen if you develop:
    • hypercalcemia (high calcium levels);
    • sudden partial or complete loss of vision;
    • hypertriglyceridemia (high triglycerides); or
    • cholestatic jaundice occurs (yellowing of the skin and eyes due to decreased bile flow).
  • Patients dependent on thyroid hormone replacement therapy should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.
  • Endometriosis may be exacerbated in women treated post-hysterectomy with estrogen-alone therapy. The addition of progestins should be considered in these patients.

Who should not take vaginal estradiol?

Do not use vaginal estradiol if you have:

  • Undiagnosed abnormal genital bleeding
  • Known, suspected or history of breast cancer
  • Known or suspected estrogen-dependent neoplasia (cancer)
  • Active deep vein thrombosis
  • Pulmonary embolism
  • A history of deep vein thrombosis, pulmonary embolism, active arterial thromboembolic disease (for example, stroke, myocardial infarction), or a history of these conditions
  • Known anaphylactic reaction or angioedema (severe allergic reaction to estradiol
  • Liver dysfunction or disease
  • Thrombophilic disorders (disorders that increase the risk of developing blood clots)
  • Known or suspected pregnancy.

 

When should I call my provider?

Contact your Rory-affiliated physician if you experience any new symptoms or if your symptoms do not change after two months of using vaginal estradiol for vaginal dryness.

What are the most common side effects of vaginal estradiol?

The most common side effects include:

  • Headache
  • Breast tenderness
  • Irregular vaginal bleeding or spotting
  • Stomach/abdominal cramps
  • Bloating
  • Nausea and vomiting
  • Hair loss
  • Vaginal burning, irritation, and itching

Systemic absorption may occur with the use of vaginal estradiol cream. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.

 

What is the FDA-approved use of vaginal estradiol cream?

Vaginal estradiol cream is a prescription medicine used to treat moderate to severe menopausal changes in and around the vagina.

What should I tell my Rory-affiliated provider before taking vaginal estradiol?

Tell your doctor if you have any of the following:

  • Undiagnosed abnormal genital bleeding
  • Known, suspected or history of breast cancer
  • Known or suspected estrogen-dependent neoplasia (cancer)
  • Active deep vein thrombosis
  • Pulmonary embolism
  • History of deep vein thrombosis of pulmonary embolism
  • active arterial thromboembolic disease (for example, stroke, myocardial infarction) or a history of these conditions
  • Known anaphylactic reaction or angioedema (severe allergic reaction  to estradiol
  • Liver dysfunction or disease
  • Thrombophilic disorders (disorders that increase the risk of developing blood clots)
  • Known or suspected pregnancy
  • Gallbladder disease
  • High blood pressure
  • High triglycerides
  • Thyroid disease
  • Hypercalcemia

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

 

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please see the full Prescribing Information, including the BOXED WARNING, for complete safety information.



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