The Food and Drug Administration (FDA) has approved fezolinetant (Veozah) to treat severe vasomotor symptoms-also called hot flashes-during menopause. Vasomotor symptoms affect up to 80% of women during menopause and most women describe them as moderate to severe. These symptoms are a common reason American women seek medical care during menopause.1

Fezolinetant is a neurokinin 3 (NK3) antagonist that binds to NK3 receptors, blocking the activity of the receptor. The NK3 pathway helps to regulate gonadotropin-releasing hormone secretion and has been implicated in the generation of hot flashes. Too much NK3 signaling in the preoptic area of the brain produces abnormal temperature regulation when estrogen levels are low, causing the body to try to dissipate heat quickly. This leads to the vasomotor symptoms experienced by menopausal women.2 While estrogen is very effective at treating vasomotor symptoms, its widespread use has fallen out of favor. The only other nonhormonal drug approved for treating hot flashes is the selective serotonin reuptake inhibitor paroxetine (Brisdelle).

Fezolinetant's approval was based on two double-blind placebo-controlled portions of two phase 3 clinical trials. A total of 1,022 women with moderate to severe vasomotor symptoms due to menopause were enrolled. A statistically significant reduction in the daily mean frequency and severity of vasomotor symptoms was found in both trials for women receiving fezolinetant compared with placebo.

The adverse effects of fezolinetant include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevations in hepatic transaminases. Fezolinetant is contraindicated in women who have cirrhosis or severe renal impairment. Drugs that are cytochrome P-450 (CYP) isoenzyme 1A2 inhibitors, such as fluvoxamine, are also a contraindication because these drugs increase the available amount of fezolinetant, making adverse effects more likely.

Nurses and NPs should use a drug database to confirm that other drug therapies the patient is taking are not CYP1A2 inhibitors. Nurses and NPs should teach patients to swallow fezolinetant daily without cutting, crushing, or chewing the tablet. Liver function studies should be completed at baseline and at three, six, and nine months after starting treatment; serum transaminase levels greater than three times the upper limit of normal have occurred with fezolinetant. Patients should be taught the importance of returning for follow-up blood work. Fezolinetant should not be started if alanine transaminase or aspartate transaminase levels are more than two times the upper limit of normal or if total bilirubin levels are elevated.

The cost for a 30-day supply of fezolinetant is $550.3 This drug is being advertised directly to consumers through a mechanism known as "help-seeking advertisements." This type of advertisement describes a grouping of symptoms and encourages the viewer to contact their physician to learn more about what help is available. The advertising campaign for fezolinetant began during the Super Bowl, three months before the drug was approved. In the commercial, women are encouraged to go to a website sponsored by the drug's manufacturer, Astellas Pharma. In the commercial, fezolinetant is not specifically named. While this type of advertising is allowed by the FDA, its use has raised ethical concerns.4

For complete prescribing information, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216578s000lbl.pdf.

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