Company:

Ther-Rx

Estrogen

Estradiol 1.53mg/spray; transdermal spray.

Moderate to severe vasomotor symptoms of menopause.

The addition of exogenous estrogens helps to alleviate the vasomotor symptoms associated with declining estrogen levels.

Evamist is designed to deliver estradiol to the blood circulation following topical application to the skin of a rapidly drying solution from a metered-dose pump. One spray of Evamist contains 1.53mg estradiol.

In a 12-week, randomized, double-blind, placebo-controlled clinical trial, a total of 454 postmenopausal women were randomized and received at least one dose of Evamist or placebo. Efficacy was determined as a statistically significant and clinically significant (at least two per day or 14 per week difference) reduction in hot flush frequency and a statistically significant reduction in severity for Evamist versus placebo. One, two, or three daily sprays of Evamist were shown to be better than placebo for relief of frequency and severity of moderate to severe vasomotor symptoms at Week 4 and Week 12.

Prime pump before 1st use. Apply to clean, dry, unbroken skin on the inside of the forearm between the elbow and wrist. Initially 1 spray daily; may increase to 2–3 sprays if needed; do not spray in the same area. Reevaluate periodically. Allow spray to dry before dressing; do not wash area for at least 30 minutes after application.

Not applicable.

Breast or estrogen-dependent carcinoma. Undiagnosed abnormal vaginal bleeding. Thromboembolic disorders (eg, stroke or MI within one year, DVT, pulmonary embolism). Thrombophlebitis. Liver dysfunction or disease. Pregnancy (Cat.X).

Use shortest duration and lowest dose consistent with treatment goals and risks. Not for prevention of cardiovascular disease (CVD) or dementia. Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Renal dysfunction. Gallbladder disease. Hypertriglyceridemia. Hypothyroidism. Hypercoagulability. Conditions aggravated by fluid retention. Bone disease associated with hypercalcemia. Do initial complete physical; repeat annually (include BP, mammogram, PAP smear). Discontinue if visual disturbances or jaundice occurs, and during immobilization, and at least 4–6 weeks before surgery associated with thromboembolism. Manage risk factors for CVD and VTE appropriately. May aggravate asthma, diabetes, epilepsy, migraine, porphyria, SLE, hepatic hemangiomas. May interfere with lab tests (eg, thyroid, PT, glucose tolerance, HDL-C/LDL-C). Product is flammable. Nursing mothers.

Avoid applying sunscreen 1 hr after (decreases estradiol absorption). May need higher doses of thyroid-replacement therapy. May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors.

Headache, breast/nipple pain, nausea, back pain, nasopharyngitis.

Pump—8.1mL (56 sprays/pump)

4/25/08