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 any unusual vaginal bleeding to find out the cause.
- Do not use estrogen-alone 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.
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older.
- Do not use estrogens with progestogens to prevent heart disease, heart attack, strokes, or dementia.
- Using estrogens with progestogens may increase your chances of getting blood clots, strokes, heart attacks, or breast cancer.
- Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age and older
- Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia.
- Because other products and doses have not been studied in the same way, it is not known how the use of Vagifem® will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem®.
What is Vagifem®?
Vagifem® (estradiol vaginal inserts) is a prescription medicine that contains estradiol (an estrogen hormone) in a vaginal insert. Vagifem® is used after menopause to treat moderate to severe menopausal changes in and around the vagina.
Important Safety Information
Who should not use Vagifem®?
Do not start using Vagifem® if you:
- have unusual bleeding
- have been diagnosed with a bleeding disorder
- 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 the ingredients in it
Before you use Vagifem®, tell your healthcare provider about all of your medical conditions, including if you:
- have any unusual vaginal bleeding
- have any other medical conditions that may become worse while you are using Vagifem®
- are going to have surgery or will be on bed rest
- are pregnant or think you may be pregnant
- are breastfeeding
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of Vagifem®?
Serious but less common side effects include: heart attack, stroke, blood clots, breast cancer, cancer of the lining of the uterus (womb), cancer of the ovary, dementia, high and low blood calcium, gallbladder disease, visual abnormalities, high blood pressure, high levels of fat (triglyceride) in your blood, liver problems, changes in your thyroid hormone levels, fluid retention, cancer changes of endometriosis, enlargement of benign tumors of the uterus (fibroids), worsening of swelling of face and tongue (angioedema) in women with a history of angioedema
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- new breast lumps
- unusual vaginal bleeding
- changes in vision or speech
- sudden new severe headaches
- severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue
Common side effects of Vagifem® include headache, breast pain, irregular vaginal bleeding or spotting, stomach or abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.
Please click here for Prescribing Information.
Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.
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
Talk to your health care provider and find out if Vagifem® 10 mcg is right for you.
