MINIVELLE® (estradiol transdermal system) is indicated for treatment of moderate to severe vasomotor symptoms due to menopause.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
Estrogen Plus Progestin Therapy
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 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. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
Estrogens increase the risk of gallbladder disease. Discontinue estrogen if severe hypercalcemia, loss of vision, 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 October 29, 2012. 2. European Monthly Prescribing Reference. Hormone replacement therapy chart. http://www.empr.com/hormone-replacement-therapy-chart/article/123738/. Accessed October 29, 2012. 3. Pharmaceuticals and Medical Devices Agency, Japan. Pharmaceuticals and Medical Devices Safety Information, No. 252, November 2008. http://www.pmda.go.jp/english/service/pdf/precautions/PMDSI-252.pdf. Accessed November 9, 2012. 4. Minivelle [Prescribing Information]. New York, NY: Noven Therapeutics, LLC; 2012. 5. Vivelle-Dot [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals, Inc.; 2004.
Minivelle® and the Minivelle Logo are trademarks of Noven Therapeutics, LLC.
Vivelle® is a registered trademark of Novartis Corporation.
Vivelle-Dot® is a registered trademark of Novartis AG.
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