Imvexxy Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol 4mcg, 10mcg; vaginal inserts.
Pharmacological Class
Estrogen.
How Supplied
Vaginal inserts—8, 18
Manufacturer
Generic Availability
NO
Imvexxy Indications
Indications
Moderate to severe dyspareunia due to menopause.
Imvexxy Dosage and Administration
Adult
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.
Children
Not applicable.
Imvexxy Contraindications
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
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
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
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