INDICATION

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.

IMPORTANT SAFETY INFORMATION

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.

  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.

  • Estrogen-alone or estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

  • The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT). The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) and increased risks of invasive breast cancer.

  • The WHI Memory Study (WHIMS) estrogen-alone and estrogen plus progestin ancillary study reported an increased risk of probable dementia in postmenopausal women 65 years of age and older.

  • 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 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.

Click here for the full Prescribing Information, including Boxed WARNING.

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.

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