Generic Name and Formulations:
Estradiol 0.05mg/day, 0.1mg/day; transdermal system.
Novartis Pharmaceuticals Corp
Indications for VIVELLE:
Moderate-to-severe vasomotor symptoms of menopause. Vulvar or vaginal atrophy due to menopause. Postmenopausal osteoporosis prevention. Hypoestrogenism.
Apply to clean, dry, intact skin (not to breasts or waist); rotate application sites. Apply Vivelle to trunk, Vivelle-Dot to lower abdomen. Menopause: Initially one 0.0375mg/day patch twice weekly. Osteoporosis: initially one 0.025mg/day patch twice weekly. Hypoestrogenism: see full labeling. With intact uterus: usually give cyclically (3 weeks on, 1 week off); without uterus: may give continuously. Transferring from oral estrogens: apply 1st patch up to 1 week after last oral dose. Adjust after at least 1 month. Reevaluate periodically.
Undiagnosed abnormal genital bleeding. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency or other thrombophilias. Breast or other estrogen-dependent neoplasms. Hepatic disease. Pregnancy.
Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.
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). Reevaluate periodically. Nursing mothers.
May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and 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).
Headache, local reactions (eg, erythema, pruritus, rash), back pain, irregular vaginal bleeding, spotting, breast tenderness, nasopharyngitis, sinusitis, upper RTI, depression; thromboembolism, neoplasms, anaphylaxis.
Vivelle—8; Vivelle-Dot—8, 24