(estradiol gel) 0.1% is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Important Safety Information for Healthcare Providers
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
See Full Prescribing Information for complete Boxed Warning
- There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
- Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
- The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
- The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older
Estrogen Plus Progestin Therapy
- Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
- The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI)
- The WHI estrogen plus progestin study reported increased risks of invasive breast cancer
- The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
Divigel® should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to Divigel®; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; or known or suspected pregnancy.
Estrogens increase the risk of gallbladder disease.
Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs.
Monitor thyroid function in women on thyroid replacement therapy.
The most common adverse reactions (incidence ≥ 5 percent) are breast tenderness, metrorrhagia, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection.
Patients should be started with the lowest effective dose and the dose should be evaluated periodically.
Alcohol-based gels are flammable. Patients should avoid fire, flame or smoking until the gel has dried.
Please see Full Prescribing Information, including Boxed Warning and Patient Counseling Information. For more information, call 732-721-0070 or visit www.divigel.com.
You are encouraged to report negative side effects to Vertical Pharmaceuticals, LLC at 1-877-95-VERTI (1-877-958-3784), or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.