One of my patients recently messaged me about the articles she is seeing in her news feed about fezolinetant. She was excited about potentially trying this newly approved medication to help with menopause symptoms that have been interfering with her work, her workouts and her sleep. She wanted to know: Should she try this drug? Or should she just live with her hot flashes?
This new medication is a big deal. Menopausal hormone therapy (MHT) is currently the main treatment for these symptoms, but certain people can’t take or are nervous about hormone therapy (HT). That’s where fezolinetant, known by the brand name Veozah, comes in.
What is menopausal hormone therapy? Who can’t take it?
Menopausal hormone therapy delivers estrogen through skin patches, creams or pills. If you have a uterus, MHT includes progesterone. If you’ve had surgery to remove your uterus (known as a hysterectomy) MHT does not necessarily include progesterone.
MHT is the fastest, most effective approach for treating vasomotor symptoms, the clinical name for the hot flashes and night sweats of menopause.
Many women choose not to take hormone therapy after menopause, often due to misconceptions about the risks. However, some women simply are not candidates for MHT even if they are interested.
The largest group of women not eligible for MHT are those with a history of breast cancer, especially if that cancer was deemed “hormone receptor positive.” In this type of cancer, the tumor has features that indicate the presence of hormones in the body — estrogen, progesterone or both — will hasten the growth of that tumor. Women who are considered at high risk of breast cancer may or may not be candidates for MHT and should certainly meet with a certified menopause expert.
Also, women who did not go through menopause recently (within the last 5 to 10 years) should not be treated with MHT if they have not already been on MHT in that interval. If you have a history of a stroke or blood clot, your risks of taking MHT are higher, so you should probably avoid MHT.
If you go through menopause early, especially before age 40 to 45, you should seriously consider hormone therapy.
What is fezolinetant? What’s the big deal?
Fezolinetant is one of only two nonhormonal medications approved by the Food and Drug Administration (FDA) to treat menopause. The other, paroxetine, was a medication already approved for mood disorders.
Fezolinetant is special and novel because of how it works. In recent years, researchers have identified a pathway related to menopausal vasomotor symptoms. In the brain, a cascade of proteins interacts with gonadotropin-releasing hormone (GnRH), which is a stimulating hormone from the hypothalamus. One protein, neurokinin B, activates the process and interferes with women’s temperature control system. Pharmaceutical researchers have found agents that block neurokinin activity at one of its many receptors, and these NK-3 receptor antagonists have been studied in symptomatic menopause.
Does fezolinetant work? What can I expect?
One study of fezolinetant included over 500 women (assigned female at birth) ages 40 to 65 from all over the world, though mostly white, who had at least seven bothersome hot flashes a day.
Study participants were given a placebo, 30 mg of fezolinetant or 45 mg of fezolinetant. After four weeks, women in the fezolinetant groups experienced a reduction in hot flash frequency and severity. At 12 weeks, hot flash frequency decreased for 45% of women in the 30 mg fezolinetant group, 57% of the 45 mg group, and 30% of the placebo group. The authors also reported improved quality of life, decreased distress related to vasomotor symptoms and fewer nighttime awakenings in the treatment groups.
When should you take fezolinetant?
Because fezolinetant’s approval is recent, its best position in treatment guidelines and algorithms remains to be determined. Certainly, fezolinetant is an exciting option for women who are not candidates or not interested in taking estrogen-based MHT. Whether fezolinetant can be used in addition to other treatments for hot flashes remains to be seen. Also, it has yet to be compared head-to-head with existing treatments such as MHT and other nonhormonal medications used in menopause.
What are the side effects of fezolinetant? Is fezolinetant safe?
The most commonly reported adverse event in women taking fezolinetant was headache. Some participants in the study also had abnormal labs related to liver function, though these were deemed mild and resolved without significant liver damage being reported.
Curiously, a high number of participants in the fezolinetant study reported side effects — whether or not they were actually given fezolinetant. In the treatment groups, 37% of the women given 30 mg of fezolinetant and 43% of the women given 45 mg of fezolinetant reported some adverse event. However, 45% of the women in the placebo group also reported adverse events, so the medication groups were no different from the placebo group in this regard.
How do I take fezolinetant?
Fezolinetant will be prescribed as 45 milligrams dosed once daily.
Stay tuned. Despite the excitement about the approval of fezolinetant, details about cost, coverage and availability are unfolding.
Back to my patient’s message: Should I just live with my hot flashes?
Girl, no — not if they are bothering you. If hot flashes are minor and not at all disruptive, maybe you don’t need to address them directly. You can dress in layers, cool your home a little more aggressively and avoid dietary triggers (looking at you, red wine).
If hot flashes interfere with social interactions, work life or just general life enjoyment, talk to your health care team about what treatments may be right for you.
Relevant reading
The New Rules of Menopause
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