In January 2013, Noven launched Minivelle® (estradiol transdermal system), the planet’s smallest estrogen therapy patch, in the U.S. This state-of-the-art patch, developed and manufactured by Noven, is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of post-menopausal osteoporosis. It is available in five dosage strengths (0.025, 0.0375, 0.05, 0.075 and 0.10 mg/day). The newly-approved 0.025 strength is indicated only for the prevention of post-menopausal osteoporosis. Noven markets and sells Minivelle® through the women’s health unit of its specialty pharmaceuticals subsidiary, Noven Therapeutics, LLC.
For more information, please visit www.minivelle.com.
Minivelle® (estradiol transdermal system) is a prescription medicine patch that contains estradiol (an estrogen hormone). Minivelle® is used to reduce moderate to severe hot flashes due to menopause and to help prevent postmenopausal osteoporosis (thin weak bones).
If you use Minivelle® only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.
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® as vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
Do not use estrogen-alone or estrogen with progestins 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, while using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
Using estrogen-alone or estrogen 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.
Before you take Minivelle®, tell your healthcare provider if you have unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, are breast feeding, and about all of the medicines you take.
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.
These are not all the possible effects of Minivelle®. Please read the Patient Information section within the full Prescribing Information before taking Minivelle®. For more information ask your healthcare provider or pharmacist for advice about side effects.
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.
For patient, physician and pharmacist inquiries regarding Minivelle®, please contact:
INC Research, LLC
441 Vine Street
Cincinnati, OH 45202
Attn: Safety Department