Safety Information for Estradiol Vaginal Suppositories (10mcg)

These highlights do not include all the information needed to use estradiol vaginal inserts safely and effectively. Please see full prescribing information for estradiol vaginal inserts.

Estradiol vaginal inserts are a prescription medication FDA-approved to treat moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When you receive your vaginal estradiol (estrogen), you'll open the box and read an FDA warning that estrogens increase risk of cancer and heart disease. These warnings have only been substantiated with higher-dose oral forms of estrogen.

Estradiol vaginal inserts are prescribed in very small doses and is applied only to the affected tissues. Vaginal estradiol is not shown to carry risk of cancer and heart disease. It can be safe for women with breast cancer, provided they have approval from their oncologist. Women's health groups and practicing clinicians have been lobbying the FDA to modify the confusing warnings.

At Interlude, we want you to feel safe and educated about your options for sexual wellness. If you are considering vaginal estradiol inserts, our medical team will determine if you are a good candidate for vaginal estradiol. We're available 24/7 to answer any questions you may have - unlimited messaging is included with your treatment.

Estradiol vaginal inserts are an estrogen indicated for the treatment of atrophic vaginitis due to menopause.

• 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 estradiol vaginal inserts. 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 or 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 estradiol vaginal inserts will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with estradiol vaginal inserts.

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

Estradiol vaginal inserts are 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 estradiol vaginal inserts to control these problems.

What are the ingredients in vaginal estradiol inserts?

Do not use vaginal estradiol 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 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.

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 estradiol vaginal inserts works. Estradiol vaginal inserts 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.

Estradiol vaginal inserts are 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 estradiol vaginal inserts.

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

Less common but serious 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 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 estradiol vaginal inserts. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away. You may report side effects to FDA at 1-800-FDA-1088.