References

  1. Divigel® [package insert]. Vertical Pharmaceuticals, LLC; 2014.
  2. Hedrick RE, Ackerman RT, Koltun WD, Halvorsen MB, Lambrecht LJ. Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. Menopause. 2009;16(1):132-140.
  3. The North American Menopause Society. The Menopause Guidebook. 7th ed. Mayfield Heights, OH: The North American Menopause Society; 2012.
  4. Data on file. Vertical Pharmaceuticals, LLC; 2014.
  5. EstroGel® [package insert]. Herndon, VA: ASCEND Therapeutics, Inc; 2009.
  6. Elestrin™ [package insert]. Philadelphia, PA: Azur Pharma, Inc; 2012.
  7. Evamist [package insert]. St. Louis, MO: Ther-Rx Corp; 2011.
  8. US Food and Drug Administration. Menopause and hormones. http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118624.htm. Updated June 20, 2012. Accessed September 27, 2012.
  9. Goodman NF, Cobin RH, Ginzburg SB, Katz IA, Woode DE; American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of menopause. Endocr Pract. 2011;17(suppl 6):1-25.
  10. Samsioe G. Transdermal hormone therapy: gels and patches. Climacteric. 2004;7(4):347-356.
  11. Deep vein thrombosis (DVT). The Merck Manual Home Health Handbook website. http://www.merck.com/mmhe/print/sec03/ch036/ch036b.html. Updated February 2008. Accessed December 18, 2012.
  12. Premarin® [package insert]. New York, NY: Pfizer Pharmaceuticals, Inc; 2012.
  13. Prempro™ [package insert]. New York, NY: Pfizer Pharmaceuticals, Inc; 2012.
  14. MedlinePlus website. Hysterectomy. http://www.nlm.nih.gov/medlineplus/hysterectomy.html. Updated October 1, 2012. Accessed October 25, 2012.
  15. Centers for Disease Control and Prevention. Women’s reproductive health: hysterectomy fact sheet. http://www.cdc.gov/reproductivehealth/WomensRH/00-04-FS_Hysterectomy.htm. Updated September 22, 2008. Accessed October 25, 2012.
  16. The North American Menopause Society. The 2012 hormone therapy position statement of The North American Menopause Society. Menopause. 2012;19(3):257-271.
  17. American College of Obstetricians and Gynecologists. FAQ: hormone therapy. American College of Obstetricians and Gynecologists website. http://www.acog.org/~/media/For%20Patients/faq066.pdf?dmc=1&ts=
    20121029T1130134979
    . Published August 2011. Accessed October 29, 2012.
  18. NCI Drug Dictionary: conjugated estrogens. National Cancer Institute website. http://www.cancer.gov/drugdictionary?CdrID=39237. Accessed January 22, 2013.
Divigel® (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

Estrogen-Alone Therapy
  • 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.

Important Safety Information & Indication
Divigel® (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

Estrogen-Alone Therapy
  • 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.