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New first of its kind medication to treat hot flashes: What PCPs need to know
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While menopause is a natural process of aging, some of its symptoms, such as hot flashes, may affect women’s well-being, according to Mayo Clinic.
“Menopausal women need primary care providers to understand menopause and help them navigate it,” JoAnn Pinkerton, MD, executive director of The North American Menopause Society and professor of obstetrics and gynecology at the University of Virginia Health System, told Healio Internal Medicine. “Seventy-five percent of women going through menopause will have hot flashes and about 25% of those will have them severe enough to need medical treatment.”
The FDA recently approved bioidentical estradiol and progesterone capsules (Bijuva, TherapeuticsMD) to manage hot flashes.
Multiple symptom relief
Bijuva is the first FDA-approved bioidentical hormone therapy combination of estradiol and progesterone for moderate to severe vasomotor symptoms associated with menopause.
“Bijuva is a systemic hormone therapy which provides about one-fifth as much estrogen and progesterone as a woman makes before menopause,” Pinkerton said.
While the new soft gel capsule medication is approved for hot flashes, it also prevents bone loss and improves vaginal dryness, she said.
“The combination of estrogen and progesterone work in the central thermoregulatory center of the brain to decrease hot flashes, in the bone to prevent bone loss and in the vagina to rebuild missing superficial cells which improve moisture of the vagina and prevent painful sex,” she said.
Candidates for Bijuva include postmenopausal women who want to start hormone therapy, are younger than 60 years or within 10 years of menopause, have bothersome menopausal hot flashes, night sweats or sleep disruption, or who have a high risk of bone loss, according to Pinkerton.
Women with prior breast or uterine cancer, liver disease, a high risk of blood clots or prior blood clots, previous heart attack, sensitivity to estrogen or progesterone, unexplained vaginal bleeding or uncontrolled high BP are contraindicated for Bijuva, she said.
Safety profile
The most common adverse reactions to Bijuva were similar to other combined menopausal hormone therapy products on the market and included breast tenderness, headache, vaginal bleeding, vaginal discharge and pelvic pain, Pinkerton said. No significant changes in cholesterol, blood sugar or clotting tests were observed, she said.
She noted that long-term use of estrogens alone or in combination with progestins increase the risk of breast cancer. Pinkerton recommended that women on estrogen alone or estrogen combined with either synthetic progestins or bioidentical progesterone undergo annual breast exams and mammograms for breast safety.
In clinical trials, Bijuva did not appear to increase the risk for uterine cancer, she said. All estrogen products contain a warning from the FDA on the potential risks of cardiovascular disorders, breast cancer, endometrial cancer and dementia, she noted.
“Many women in the past desiring bioidentical hormone therapy have used non-FDA approved compounded therapies which are neither FDA-monitored or -regulated with safety concerns due to the possibility of over or under dosing, presence of contaminants, adequate sterility, and the lack of testing about safety and efficacy,” Pinkerton said.
This novel combined estradiol/progesterone therapy gives women with a uterus seeking bioidentical hormone therapy a new safe and effective option to relieve hot flashes, she said.
Bijuva can be initiated in any symptomatic menopausal women who has been counseled about the pros and cons of hormone therapy, she said. – by Alaina Tedesco
Disclosure: Pinkerton reports no relevant financial disclosures.