MINIVELLE® (estradiol transdermal system) is indicated for treatment of moderate to severe vasomotor symptoms due to menopause. MINIVELLE is also indicated for prevention of postmenopausal osteoporosis. The 0.025 mg/day dose is only approved for the prevention of postmenopausal osteoporosis.
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
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 history of arterial thromboembolic disease (e.g., stroke or MI); known anaphylactic reaction or angioedema with MINIVELLE, liver dysfunction or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; or known or suspected pregnancy.
Estrogens increase the risk of gallbladder disease. Discontinue estrogen if severe hypercalcemia, vision abnormalities, severe hypertriglyceridemia or cholestatic jaundice occurs. Monitor thyroid function in women on thyroid replacement therapy.
In clinical trials with Vivelle® (estradiol transdermal system), the most common side effects (≥5%) were headache, breast tenderness, back pain, pain in limb, nasopharyngitis, dyspepsia, nausea, sinusitis, and intermenstrual bleeding.
These are not all the side effects of Minivelle.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
References: 1. U.S. Food and Drug Administration. Estrogen and estrogen with progestin therapies for postmenopausal women. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm135318.htm#.UI4ZzYBzknM.email. Accessed April 24, 2015. 2. Monthly Prescribing Reference. Hormone replacement therapy chart. http://www.empr.com/hormone-replacement-therapies/article/123738/. Accessed April 24, 2015. 3. Pharmaceuticals and Medical Devices Agency, Japan. Pharmaceuticals and Medical Devices Safety Information, No. 252, November 2008. https://www.pmda.go.jp/files/000153450.pdf. Accessed April 24, 2015. 4. Minivelle [Prescribing Information]. New York, NY: Noven Therapeutics, LLC; 2014.
Minivelle® and the Minivelle Logo are trademarks of Noven Therapeutics, LLC.
Vivelle® is a registered trademark of Novartis Corporation.
© 2014, 2015 Noven Therapeutics, LLC. All rights reserved. For U.S. Audience Only. MINI-2103-15 05/15