Evamist.com HCP – Evamist® efficacy (estradiol transdermal spray)

Reduce her hot flashes with Evamist^®

Evamist is proven to reduce the frequency and severity of moderate-to-severe hot flashes with 17ß-estradiol, delivered transdermally directly into the bloodstream.¹ In an experience study, Evamist patients were very satisfied with the hot flash relief they experienced with Evamist.²

In fact, Evamist was ranked 7.3 out of 9 in satisfaction for hot flash relief^*2

Patients experienced reductions that increased over time as they continued with therapy

In a clinical study, reductions in frequency were statistically significant vs placebo by Week 4 with all 3 doses (P<0.003) and were sustained throughout the 12 weeks of treatment (P<0.001).¹

Evamist provides peak delivery during sleep hours

Evamist provides continuous delivery of estradiol, with peak delivery during sleep hours.^1,2 In a clinical study, serum levels of Evamist after an 8 AM dose were found to peak between the hours of 2 AM and 6 AM.²

In a single-center, randomized, open-label, parallel-group study, 24 healthy postmenopausal women were randomly assigned to receive one spray of Evamist applied to the inner forearm of the same arm once daily at 8 AM for 14 days.^1,2

» References

*In an experience study of 247 women using Evamist.²

Important Safety Information

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.

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.