IMVEXXY(estradiol vaginal inserts)
IMVEXXY Rx
Generic Name and Formulations:
Estradiol 4mcg, 10mcg; vaginal inserts.
Company:
TherapeuticsMD, Inc.
Indications for IMVEXXY:
Moderate-to-severe dyspareunia due to menopause.
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. Reeva luate periodically.
Children:
Not established.
Contraindications:
Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer or estrogen-dependent neoplasia. Active DVT, PE, or history of these conditions. Active arterial thromboembolic disease (eg, stroke, MI) or a history of these conditions. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Hepatic impairment or disease. Known anaphylactic reaction or angioedema.
Boxed Warning:
Endometrial cancer. Cardiovascular disorders. Breast cancer. Probable dementia.
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. 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, BP). Reeva luate periodically.
Pharmacological Class:
Estrogen.
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).
Adverse Reactions:
Headache; thromboembolism, neoplasms.
Generic Availability:
NO
How Supplied:
Vaginal inserts—8, 18
http://www.imvexxy.com/hcp/ |
