Important Safety Information for Evamist® (estradiol transdermal spray)
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER, PROBABLE DEMENTIA, AND UNINTENTIONAL SECONDARY EXPOSURE TO ESTROGEN
See full prescribing information for complete boxed warning.
- 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 risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI)
- The WHI estrogen plus progestin substudy 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
Unintentional Secondary Exposure
- Breast budding, breast masses, and gynecomastia have been reported in children following unintentional secondary exposure to Evamist
Evamist® (estradiol transdermal spray) should not be used in women with the following: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease (for example, stroke and MI), or history of these conditions; known anaphylactic reaction or angioedema with Evamist; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; or known or suspected pregnancy.
Estrogens increase the risk of gallbladder disease. Estrogens may lead to severe hypercalcemia in women with breast cancer and bone metastases. Retinal vascular thrombosis has been reported in women receiving estrogen. In women with preexisting hypertriglyceridemia, estrogen may be associated with elevations of plasma triglycerides leading to pancreatitis. Estrogens may be poorly metabolized in women with impaired liver function. Monitor thyroid function in women on thyroid replacement therapy. Estrogens may cause fluid retention. Estrogens should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur. Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema and may cause an exacerbation ofasthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas in women with these conditions.
Avoid fire, flame or smoking until Evamist® (estradiol transdermal spray) spray has dried. When sunscreen is applied approximately one hour after application of Evamist, estradiol absorption was decreased by 11 percent.
In a clinical trial, the most common adverse reactions that occurred with Evamist® (estradiol transdermal spray) were headache, breast tenderness and nipple pain, nausea, back pain, and nasopharyngitis.
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.