Vagifem (Estradiol): Uses, Side Effects and Dosage

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 is a prescription medicine that contains estradiol (an estrogen hormone) in a vaginal insert.

What is Vagifem used for?

Vagifem is used after menopause to:

• Treat moderate to severe menopausal changes in and around the vagina
• You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem to control these problems.

Who should not use Vagifem?

Do not start using Vagifem if you:

• have unusual vaginal bleeding
• 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.
• have been diagnosed with a bleeding disorder
• 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 (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use Vagifem.
• 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.
• See the list of ingredients in Vagifem at the end of this leaflet.

Before you use Vagifem, tell your healthcare provider about all of your medical conditions, including if you:

• have any unusual vaginal bleeding
• 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.
• have any other medical conditions that may become worse while you are using Vagifem
• Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• are going to have surgery or will be on bed rest
• Your healthcare provider will let you know if you need to stop using Vagifem.
• are pregnant or think you may be pregnant
• Vagifem is not for pregnant women.
• are breastfeeding
• The hormone in Vagifem can pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Vagifem works. Vagifem may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get new medicines.

How should I use Vagifem?

Vagifem is an insert that you place in your vagina with an applicator.

• Take the dose recommended by your healthcare provider and talk to him or her about how well that dose is working for you
• Estrogens should be used at the lowest dose possible for your treatment and only as long as you need to use this medicine.
• You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are using and whether you still need treatment with Vagifem.

What are the possible side effects of Vagifem?

Side effects are grouped by how serious they are and how often they happen when you are treated.

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
• vaginal yeast infection

These are not all the possible side effects of Vagifem. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects the bother you or do not go away. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to Novo Nordisk at 1-888-824-4336.

What can I do to lower my chances of a serious side effect with Vagifem?

• Talk with your healthcare provider regularly about whether you should continue using Vagifem
• If you have a uterus, talk with your healthcare provider about whether the addition of a progestogen is right for you
• In general, the addition of a progestogen is recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb). See your healthcare provider right away if you get vaginal bleeding while using Vagifem.
• Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

How should I store Vagifem?

Store Vagifem at room temperature 68ºF to 77ºF (20º C to 25ºC); excursions permitted to 59ºF to 86ºF (15ºC to 30ºC).

Do not refrigerate.

[see USP Controlled Room Temperature].

Keep Vagifem out of the reach of children

General information about the safe and effective use of Vagifem.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Vagifem for conditions for which it was not prescribed. Do not give Vagifem to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Vagifem that is written for health professionals. You can get more information by calling the toll-free number 1-888-824-4336.

What are the ingredients in Vagifem?

Vagifem (estradiol vaginal inserts) are small, white, film-coated inserts containing estradiol. Each insert also contains hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol.

Each Vagifem insert is contained in a disposable applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset inserts.

Manufactured by: Novo Nordisk A/S DK-2880 Bagsværd, Denmark

For more information contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, USA, 1-888-824-4336.

This Patient Information has been approved by the U.S. Food and Drug Administration

Revised 09/2022