Vagifem® 10 mcg to Replace Vagifem® 25 mcg Formulation for Atrophic Vaginitis
New Low-dose Option in Line with Medical Recommendations
Princeton, NJ, May 20, 2010 /PRNewswire/ — Novo Nordisk Inc. announced today that Vagifem® (estradiol vaginal tablets) 10 mcg will become the only available formulation of Vagifem® in the U.S., in line with medical recommendations for women to use the lowest effective estrogen dose to treat the symptoms of atrophic vaginitis due to menopause. The company will discontinue the sale of Vagifem® 25 mcg tablets in the U.S. on July 30, 2010.
Medical societies, such as the North American Menopause Society, have recommended that the lowest effective dose of estrogen consistent with treatment goals, benefits, and risks for the individual woman should be the therapeutic goal. Novo Nordisk received approval for Vagifem® 10 mcg in November 2009. Vagifem® 10 mcg delivers estrogen directly to the vagina via a small tablet that is easy to insert with a pre-loaded applicator. The estrogen in Vagifem® 10 mcg, estradiol, is identical to the estrogen produced by a woman's body.
“We want to ensure that women with symptoms of atrophic vaginitis know that new low- dose Vagifem 10 mcg is available,” said Per Falk, MD Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk. “We have a long clinical development history in the area of women’s health, and the recent introduction of Vagifem 10 mcg reaffirms our commitment to patient care and the medical community.”
Patients currently taking Vagifem® 25 mcg should visit www.newdosingoption.com or call 1-866-668-6336 and ask their healthcare provider if switching to Vagifem 10 mcg is appropriate for them. Vagifem 25 mcg will only be available through U.S. pharmacies and wholesalers while supplies last.
Atrophic vaginitis, commonly referred to as vaginal atrophy, is directly related to the loss of estrogen associated with menopause, and is a condition experienced by up to 75 percent of postmenopausal women. It is caused by the resulting thinning and shrinking of vaginal tissues and the decreased lubrication of the vaginal walls, which can lead to vaginal dryness, soreness, vaginal and or vulvar itching and irritation, painful sexual intercourse and light bleeding after intercourse.
Vagifem® 10 mcg is the only prescription vaginal tablet in a pre-loaded applicator to treat menopausal changes in and around the vagina.
For more information about Vagifem®, visit http://www.vagifem.com.
Important Safety Information
What is the most important information you should know about Vagifem® (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 Vagifem®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Vagifem. Your healthcare provider should check any unusual vaginal bleeding to find the cause.
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of 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 age 65 years or older.
Do not use estrogens with progestins to prevent heart disease, heart attack, or dementia.
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
Using estrogens with progestin may increase your chance of getting dementia, based on a study of women 65 years and older.
You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem®.
Vagifem® is used after menopause to treat menopausal changes in and around the vagina.
Do not start using Vagifem® 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, are allergic to Vagifem® or any of its ingredients, or think you may be pregnant.
The most commonly reported side effects of Vagifem® included: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention and vaginal yeast infection.
Vagifem® is a registered trademark of Novo Nordisk FemCare AG.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 87 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. Headquartered in Denmark, Novo Nordisk employs more than 29,000 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk-us.com.
For further information, please contact: