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.
Important Safety Information & Indication

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
  • You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®

Divigel® should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, including cancer of the breast or uterus, 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, are allergic to Divigel® or any of its ingredients, or think you may be pregnant.

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.

Common side effects that may occur with Divigel® include headache; breast pain; irregular vaginal bleeding or spotting; stomach or abdominal cramps, bloating; nausea and vomiting; hair loss; fluid retention and vaginal yeast infection.

Serious but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the uterus, ovarian cancer, high blood pressure, high blood sugar, gallbladder disease, liver problems, and enlargement of benign uterus tumors (“fibroids”).

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

Please see Patient Information for Divigel® and talk to your healthcare provider. 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
Important Safety Information & Indication

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
  • You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®

Divigel® should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, including cancer of the breast or uterus, 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, are allergic to Divigel® or any of its ingredients, or think you may be pregnant.

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.

Common side effects that may occur with Divigel® include headache; breast pain; irregular vaginal bleeding or spotting; stomach or abdominal cramps, bloating; nausea and vomiting; hair loss; fluid retention and vaginal yeast infection.

Serious but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the uterus, ovarian cancer, high blood pressure, high blood sugar, gallbladder disease, liver problems, and enlargement of benign uterus tumors (“fibroids”).

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

Please see Patient Information for Divigel® and talk to your healthcare provider. 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.