EVAMIST Dosage & Rx Info | Uses, Side Effects

Evamist Generic Name & Formulations

Legal Class

General Description

Estradiol 1.53mg/spray; transdermal spray; contains alcohol.

Pharmacological Class

Estrogen.

How Supplied

Metered-dose pump—8.1mL (56 sprays/pump)

Storage

Store at room temperature 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F). Do not freeze.

Manufacturer

Padagis US LLC

Generic Availability

Mechanism of Action

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH, through a negative feed back mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

Evamist Indications

Indications

Moderate to severe vasomotor symptoms due to menopause.

Evamist Dosage and Administration

Adult

Prime pump before 1^st 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. Active DVT, PE, or history of. Active arterial thromboembolic disease (eg, stroke, MI) or a history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

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, stroke, MI, VTE); discontinue if these occur or are suspected. 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. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Preexisting hypertriglyceridemia. History of cholestatic jaundice. Discontinue if pancreatitis, hypercalcemia, or recurrence of cholestatic jaundice occurs. Monitor thyroid function. Monitor conditions that may predispose to 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. Pregnancy: not indicated. Nursing mothers.

Evamist Pharmacokinetics

Absorption

Serum concentrations of estradiol appeared to reach steady state after 7–8 days of application of one, two, or three 90 mcL sprays of Evamist per day.

Distribution

Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in blood largely bound to SHBG and albumin.

Metabolism

Hepatic.

Elimination

Renal.

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