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Indication
Evamist is indicated for the treatment of moderate-to-severe vasomotor symptoms
due to menopause.
WARNING—ENDOMETRIAL CANCER, CARDIOVASCULAR, AND OTHER RISKS
ENDOMETRIAL CANCER Adequate diagnostic measures, including endometrial
sampling when indicated, should be undertaken to rule out malignancy in all cases
of undiagnosed persistent or recurring abnormal vaginal bleeding.
CARDIOVASCULAR AND OTHER RISKS
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) in postmenopausal women (50 to 79 years
of age) during 6.8 years and 7.1 years, respectively, of treatment with daily oral
conjugated estrogens (CE 0.625 mg), relative to placebo. The estrogen plus progestin
WHI substudy reported increased risk of myocardial infarction, stroke, invasive
breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79 years
of age) during 5.6 years of treatment with daily oral CE 0.625 mg combined with
medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. The Women’s Health
Initiative Memory Study (WHIMS), a substudy of the WHI, reported increased risk
of developing probable dementia in postmenopausal women 65 years of age or older
during 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of
treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo.
It is unknown whether this finding applies to younger postmenopausal women. In the
absence of comparable data, these risks should be assumed to be similar for other
doses of CE and MPA and other combinations and dosage forms of estrogens and progestins.
Because of these risks, 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.
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, nasopharyngitis, nipple pain, back pain, nausea, and arthralgia.
Please see
full prescribing information
for Evamist, including boxed warnings.
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