Important safety information: Evamist

INDICATION

Evamist^® is indicated for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER, PROBABLE DEMENTIA and UNINTENTIONAL SECONDARY EXPOSURE TO ESTROGEN

See full prescribing information for complete boxed warning

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 risks of stroke, DVT, pulmonary embolism, and myocardial infarction
•	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

Estrogens with or without progestins should be prescribed at the lowest effective doses for the shortest duration consistent with the treatment goals for the individual woman.

Unintentional Secondary Exposure

Breast budding and breast masses in prepubertal females and gynecomastia and breast masses in prepubertal males have been reported following unintentional secondary exposure to Evamist by women using this product. In most cases, the condition resolved with removal of Evamist exposure. Women should ensure that children do not come into contact with the site(s) where Evamist is applied. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Evamist is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

Evamist should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.

In a clinical trial with Evamist the most common side effects were headache, breast tenderness, nipple pain, nausea, back pain and nasopharyngitis

Please see full prescribing information for Evamist, including boxed warnings.

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