INDICATION
Vivelle-Dot is indicated for: treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause; treatment of hypoestrogenism due to hypogonadism, bilateral oophorectomy, or primary ovarian failure; and the prevention of postmenopausal osteoporosis. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Vivelle-Dot 0.025 mg/day is indicated for the prevention of postmenopausal osteoporosis only. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis after nonestrogen medications have been carefully considered.
IMPORTANT SAFETY INFORMATION
Estrogens increase the risk of endometrial cancer. Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.
The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo.
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy.
Other doses of oral conjugated estrogens with MPA, and other combinations and dosage forms of estrogens and progestins, were not studied in the WHI clinical trials, and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Estrogens should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.
In clinical trials with Vivelle® (estradiol transdermal system), the most common side effects were headache, breast tenderness, and back pain.