Products - Vivelle-Dot™

Vivelle-Dot^® (estradiol transdermal system)

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. By area, it is about one-third the size of Climara^Ž (Berlex) and about one-quarter the size of Estraderm^Ž (Novartis). The .025 mg/day dosage strength is the size of a dime (2.5cm²).

Noven’s market research indicated that patients would prefer a smaller, less conspicuous estrogen patch that is well-suited to an active lifestyle. In response, Noven engineered a new generation system – by far the smallest available – that is thin, translucent and extremely adherent, permitting patients to exercise, shower and swim without the need to change patches.

Vivelle-Dot^® utilizes Noven’s proprietary DOT Matrix^Ž 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

For patient and physician inquiries regarding
Vivelle-Dot^®, please contact:

Customer Interaction Center
Novartis Pharmaceuticals Corporation
One Health Plaza
Building 122
East Hanover, New Jersey 07936
Phone: 888-669-6682
Fax: 973-781-3115
Click here for E-mail Contact

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT VIVELLE-DOT (AN ESTROGEN HORMONE)?

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 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.

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.

You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot. The information contained within this Web site is appropriate for U.S. residents only. A visit to this site should not replace a visit to your doctor.

Available by prescription only.