In recognition of World Menopause Month, Avion Pharmaceuticals will be attending the North American Menopause Society Annual Meeting and hosting an informative product theater to educate health care providers about the benefits of their product, Divigel, a transdermal estrogen gel for the treatment of moderate to severe hot flashes due to menopause. Divigel can be an important partner to women at this stage of their lives and is demonstrated to help reduce the incidence of hot flashes by up to 90% in 12 weeks1,2. The discreet, portable, and easy to use Divigel packets can allow patients to enjoy and embrace this time of change in their lives.

“The Women’s Health team has done an excellent job relaunching Divigel as a safe and effective treatment option to address the nagging symptoms of Menopause. We are delighted to be able to help to create awareness and add to the discussion around an important topic that has such significant impact on a woman’s day to day life and activities,” stated Shannon Faught, CCO of Alora Pharmaceuticals.

According to the 2022 Hormone Therapy Position Statement released by the North American Menopause Society (NAMS), hormone therapy remains the most effective treatment for hot flashes and genitourinary syndrome of menopause.3 It is key for women to remember that treatment should be personalized and a shared decision between themselves and their provider. Further information regarding menopause and the statement made by the North American Menopause Society can be found at menopause.org or on Facebook by searching “North American Menopause Society”.

About Avion Pharmaceuticals, LLC.

Avion Pharmaceuticals is committed to quality and determined to deliver products that improve patients’ health and well-being. Our Women’s Health portfolio features versatile products that can help meet the individual priorities of women throughout their lives—from pregnancy prevention to prenatal care to menopause relief. For additional information about Avion Pharmaceuticals please contact the company at 678-325-5188.

 

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REFERENCES: 1. 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. 2. Divigel®[package insert]. Vertical Pharmaceuticals, LLC; 2019. 3. North American Menopause Society. The 2022 hormone therapy position statement of The North American Menopause Society. Accessed July 7, 2022. https://www.menopause.org/publications/professional-publications/position-statements-other-reports

 

IMPORTANT SAFETY INFORMATION & INDICATION, including BOXED WARNING

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 1-800-444-5164, 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 1-800-444-5164 or visit www.divigel.com.

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