Generic Name and Formulations:
Estradiol 1.53mg/spray; transdermal spray.
Indications for EVAMIST:
Moderate-to-severe vasomotor symptoms of menopause.
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. Allow spray to dry before dressing; do not wash area for at least 1hr after application.
Undiagnosed abnormal genital bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Known hepatic impairment. Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. Pregnancy (Cat.X).
Use shortest duration and lowest dose consistent with treatment goals and risks. Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Risk of unintentional secondary exposure to prepubertal children. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Reevaluate periodically. Product is flammable. Nursing mothers.
Avoid applying sunscreen 1hr after (decreases estradiol absorption). May need higher doses of thyroid-replacement therapy. May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Headache, breast tenderness/nipple pain, nausea, back pain, nasopharyngitis.
Pump—8.1mL (56 sprays/pump)