Evamist Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol 1.53mg/spray; transdermal spray; contains alcohol.
Pharmacological Class
Estrogen.
How Supplied
Metered-dose pump—8.1mL (56 sprays/pump)
Manufacturer
Evamist Indications
Indications
Moderate-to-severe vasomotor symptoms of menopause.
Evamist Dosage and Administration
Adult
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. Use shortest duration and lowest dose consistent with treatment goals and risks.
Children
Not applicable.
Evamist Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy.
Evamist Boxed Warnings
Boxed Warning
Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia. Unintentional secondary exposure.
Evamist Warnings/Precautions
Warnings/Precautions
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Risk of unintentional secondary exposure to prepubertal children. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. 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 annually (include Pap smear, mammogram, and BP). Flammable. Reevaluate periodically. Nursing mothers: not recommended.
Evamist Pharmacokinetics
See Literature
Evamist Interactions
Interactions
May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). Avoid applying sunscreen 1hr after (decreases estradiol absorption). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Evamist Adverse Reactions
Adverse Reactions
Headache, breast tenderness, nipple pain, nausea, back pain, nasopharyngitis; thromboembolism, neoplasms.
Evamist Clinical Trials
See Literature
Evamist Note
Not Applicable
Evamist Patient Counseling
See Literature
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