Low serum estradiol levels: Evamist low-dose transdermal profile

Evamist delivers efficacy with low serum estradiol levels

Estrogen should be used in the lowest dose for the shortest duration needed to provide relief, as recommended by the FDA.¹ Evamist delivers a low dose of 17ß-estradiol from a plant-based source, with a mean serum concentration of 19.6 pg/mL, as measured on Day 14 with 1 spray.^2,3

Evamist has proven efficacy with low serum estradiol levels compared with other transdermal estrogen therapies.

Serum estradiol concentrations obtained from respective prescribing information and/or published clinical trials, not comparative clinical studies. Studies may have used different analytical methods to measure serum concentrations. Relative differences in efficacy and safety, if any, may not correlate with the serum estradiol concentrations measured in these studies.

^†Unadjusted for baseline. Mean serum estradiol concentration on Day 14.

^‡Mean serum estradiol concentration on Day 7.

^§Time-averaged serum estradiol concentration on Day 14.

^║

Unadjusted for baseline. Mean serum estradiol concentration over the application period.

^¶Mean trough serum estradiol concentration at Week 12.

Transdermal therapy avoids first-pass hepatic metabolism

By using transdermal technology, Evamist delivers estrogen directly to the bloodstream, allowing the use of lower doses than oral formulations and bypassing the liver.^2,12

In a clinical trial, Evamist had a low incidence of observed
side effects²

	Side effects were low and similar to placebo³
	No apparent correlation between incidence of side effects and increase in dosage³
	Local site irritation was observed in only 1.3% of women treated with Evamist vs 1.8% treated with placebo³

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Other warnings and precautions

Other risks reported with estrogen therapy include gallbladder disease; hypercalcemia; visual abnormalities; increased risk of breast cancer, adverse effects on lipoprotein metabolism, and impairment of glucose control when a progestin is added to estrogen therapy; elevated blood pressure; hypertriglyceridemia; hypothyroidism; fluid retention; hypocalcemia; and exacerbation of endometriosis and other conditions.

Divigel^® is a registered trademark of Upsher-Smith Laboratories, Inc. Elestrin™ is a trademark of Kenwood Therapeutics. Climara^® is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc. EstroGel^® is a registered trademark of LaSalle Laboratories, Inc. Estraderm^® and Vivelle-Dot^® are registered trademarks of Novartis Pharmaceuticals Corporation. Estrasorb^® is a registered trademark of Esprit Pharma.

» Footnote References

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.