INDICATION

MINIVELLE® (estradiol transdermal system) is a prescription medicine patch that contains estradiol (an estrogen hormone). MINIVELLE is used to treat moderate to severe hot flashes due to menopause.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MINIVELLE (an estrogen hormone)?

  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using MINIVELLE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with MINIVELLE

MINIVELLE should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to MINIVELLE or any of its ingredients, or think you may be pregnant.

The most common side effects that may occur with MINIVELLE are headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses and irregular vaginal bleeding or spotting.

MINIVELLE should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks.

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.

DOT Matrix™ is a trademark of Noven Pharmaceuticals, Inc.

Minivelle® and the Minivelle Logo are trademarks of Noven Therapeutics, LLC.

Vivelle-Dot® is a registered trademark of Novartis AG.

All other registered trademarks are the property of their respective owners.

For information, call 1‑800‑455‑8070.


© Noven Therapeutics, LLC. 2013. All rights reserved. For U.S. Audience Only. MINI-3025 3/13