Generic Name and Formulations:
Estradiol 1.53mg/spray; transdermal spray.
Company:
Lumara Health
 
Select therapeutic use: Menopause and HRT
Indications for EVAMIST:
Moderate to severe vasomotor symptoms of menopause.

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.

Children:
Not applicable.

Contraindications:
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).

Warnings/Precautions:
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. Endometrial, breast, or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. Consider the addition of a progestin in patients with an intact uterus to avoid endometrial hyperplasia. 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). Reeva luate periodically. Product is flammable. Nursing mothers.

Interactions:
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).

Pharmacological Class:
Estrogen.

Adverse Reactions:
Headache, breast tenderness/nipple pain, nausea, back pain, nasopharyngitis.

How Supplied:
Pump—8.1mL (56 sprays/pump)