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Prescribing Information | Important Safety Information

Divigel® (estradiol gel) 0.1% is indicated for the treatment of moderate to severe hot flashes due to menopause.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT DIVIGEL (AN ESTROGEN HORMONE)

  • Using estrogen-alone increases your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Divigel. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual bleeding to find out 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 65 years of age or older

  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia

  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots

  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older

  • Only one estrogen-alone product and dose has been shown to increase your chances of getting strokes, blood clots, and dementia. Only one estrogen with progestin product and dose has 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 Divigel will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel.

Do not use Divigel if you have unusual vaginal bleeding, currently have or have had certain cancers, including cancer of the breast or uterus (womb), 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, or if you are allergic to Divigel or any of its ingredients.

Tell your healthcare provider about all of your medical problems and the medicines you take, if you are going to have surgery or will be on bed rest, and if you are breastfeeding.

Call your healthcare provider right away if you get any of the following symptoms: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, or severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

The most common side effects of Divigel include irregular vaginal bleeding or spotting; breast tenderness, vaginal yeast infection, cold, and upper respiratory tract (nose, sinuses, pharynx or larynx) infection.

Serious but less common side effects include stroke, blood clots, heart attack, cancer of the lining of the uterus (womb), breast cancer, cancer of the ovary, dementia, gallbladder disease, high blood calcium (hypercalcemia), high blood pressure, high triglyceride (fat levels in your blood), liver problems, low thyroid levels in your blood, fluid retention, low blood calcium (hypocalcemia), enlargement of benign uterus tumors (“fibroids”), worsening of angioedema (swelling of face and tongue), changes in certain laboratory test results, and high blood sugar.

Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

You may report side effects to Vertical Pharmaceuticals, LLC at 1-877-482-3788, or to the FDA at 1-800-FDA-1088.

For more information, please see full Patient Information for Divigel and talk to your healthcare provider. You may also call customer service at 866-677-0047.