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What is Hormone Therapy?

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Hormone Therapy Patient Assistance Program

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What is Hormone Therapy?

We have been providing women's hormone therapy products worldwide for more than 25 years. We manufacture and sell two hormone therapy products: Vagifem and Activella. Both products have been available in the U.S. since mid-2000 and Novo Nordisk is excited to offer the lowest vaginal estrogen commercially available.


Important Safety Information for Hormone Therapy Products
VAGIFEM® 10 MCG (estradiol vaginal tablets)

Indications and Usage:

Vagifem® (estradiol vaginal tablets) is used after menopause to treat menopausal changes in and around the vagina.


Important Safety Information:
What is the most important information I 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). Your healthcare provider should check 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®

Do not start using Vagifem® if you currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. Also, do not start using Vagifem® if you have unusual vaginal bleeding, 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 Vagifem® or any of its ingredients, or think you may be pregnant.

Vagifem® is only used in the vagina; however, the risks associated with oral estrogens should be taken into account.

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.

Estrogens should be used at the lowest dose possible for your treatment only as long as needed.

Please click here (PDF) for Vagifem® Prescribing Information.

Vagifem® is a prescription medication.

Talk to your doctor to see if Vagifem® is right for you.

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.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

ACTIVELLA® ([estradiol/norethindrone acetate] tablets)

Indications and Usage:

Activella® 0.5 mg/0.1 mg (estradiol/norethindrone acetate) tablets is used after menopause in women who have a uterus to reduce moderate to severe hot flashes and help reduce your chances of getting osteoporosis (thin weak bones). If you use Activella® only to prevent osteoporosis, talk to your health care provider about whether a different treatment or medicine without estrogens might be better for you.
 

Important Safety Information:
 

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ACTIVELLA® (a combination of estrogen and progestin hormones)?

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 chance of getting heart attacks, strokes, breast cancer, and blood clots.

Do not use estrogens with or without progestins to prevent dementia. Using estrogens with or without progestins may increase your risk of dementia.

You and your health care provider should talk regularly about whether you still need treatment with Activella®.

Do not take Activella® if you have had your uterus removed (hysterectomy). Do not start taking Activella® 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 past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to Activella® or any of its ingredients, think you may be pregnant, or are breast feeding.

In woman with a uterus, the use of estrogen alone may increase the chance of getting cancer of the tissue lining the uterus. Therefore, contact your doctor right away if you have unusual vaginal bleeding.

In a clinical trial, the most commonly reported adverse events (reported at a frequency of ≥5%) were back pain, pain in arms and legs, headache, nausea, diarrhea, upper respiratory tract infection, uterine thickening and vaginal bleeding.

Estrogens and progestins should be used at the lowest dose possible for your treatment only as long as needed.

Please click here (PDF) for Activella® Prescribing Information.

Activella® is a prescription medication.

Talk to your doctor to see if Activella® is right for you.

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.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.