• Menopause and HRT

Imvexxy Generic Name & Formulations

General Description

Estradiol 4mcg, 10mcg; vaginal inserts.

Pharmacological Class


How Supplied

Vaginal inserts—8, 18


Generic Availability


Imvexxy Indications


Moderate to severe dyspareunia due to menopause.

Imvexxy Dosage and Administration


Use lowest effective dose for the shortest duration. Initially one 4mcg insert intravaginally once daily for 2 weeks, then 1 insert twice weekly every 3–4 days. Reevaluate periodically.


Not applicable.

Imvexxy Contraindications


Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.

Imvexxy Boxed Warnings

Boxed Warning

Endometrial cancer. Cardiovascular disorders. Breast cancer. Probable dementia.

Imvexxy 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 disorders (eg, stroke, DVT, VTE); discontinue if occurs or 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. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or hypercalcemia occurs. Monitor thyroid function. Monitor conditions that may predispose to fluid retention (eg, cardiac or renal impairment); discontinue if medically concerning fluid retention occurs. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, BP). Reevaluate periodically. Pregnancy: not indicated. Nursing mothers: not recommended.

Imvexxy Pharmacokinetics

See Literature

Imvexxy Interactions


May be antagonized by CYP3A4 inducers (eg, St. John's wort, phenobarbital, carbamazepine, rifampin). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). 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).

Imvexxy Adverse Reactions

Adverse Reactions

Headache; thromboembolism, neoplasms.

Imvexxy Clinical Trials

See Literature

Imvexxy Note

Not Applicable

Imvexxy Patient Counseling

See Literature