World’s
Smallest Estrogen Patch
Most Dispensed Estrogen Patch in U.S.
In
May 1999, Vivelle-Dot® (estradiol transdermal system),
the world’s smallest transdermal estrogen delivery system, was
launched in the U.S. This state-of-the-art patch was approved for
the treatment of the symptoms of menopause. Vivelle-Dot® is
marketed and sold by Novogyne Pharmaceuticals, a women’s health
products company jointly owned by Noven and Novartis.
Vivelle-Dot® is indicated for the treatment of the symptoms of menopause, and the prevention of postmenopausal osteoporosis. Vivelle-Dot® is available in five dosage strengths (.025, .0375, .05, .075 and .10 mg/day) with the .025 dosage strength indicated for the prevention of postmenopausal osteoporosis only. These five strengths provide prescribing physicians with broad dosing flexibility. In the most commonly prescribed dosage strength (.05 mg/day), Vivelle-Dot® is about the size and thickness of a postage stamp. The .025 mg/day dosage strength is the size of a dime (2.5cm2).
Vivelle-Dot® utilizes
Noven’s proprietary DOT Matrix® adhesive technology
and delivers estradiol through the skin and into the bloodstream.
The technologies incorporated into Vivelle-Dot® are
the subject of a number of U.S. patents.
For more information, please visit www.vivelledot.com
INDICATION
Vivelle-Dot
is used after menopause to: reduce moderate to severe hot flashes;
treat moderate to severe dryness, itching and burning in or around
the vagina; help reduce your chances of getting osteoporosis (thin
weak bones); and treat certain conditions in which a young woman’s
ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025
mg/day is only used to prevent osteoporosis from menopause. If you
use Vivelle-Dot only to treat your dryness, itching, and burning
in and around your vagina or if you use Vivelle-Dot only to prevent
osteoporosis from menopause, talk with your healthcare professional
about whether a different treatment or medicine without estrogens
might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens
increase the chances of getting cancer of the uterus (womb). Report
any unusual vaginal bleeding right away while you are taking estrogens.
Vaginal bleeding after menopause may be a warning sign of cancer
of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
Click here for the Full Prescribing Information for Vivelle-Dot
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FCA-1088.
Available by prescription
only.
For patient, physician
and pharmacist inquiries
regarding Vivelle-Dot®, please contact:
Customer Interaction
Center
Novartis Pharmaceuticals Corporation
One Health Plaza
Building 122
East Hanover, New Jersey 07936
Ph: 888-669-6682
Fax: 973-781-3115
Click
here for E-mail Contact