Fezolinetant Basics for Patients

Fezolinetant is an FDA-approved drug for treating hot flashes.¹ Astellas Pharma sells it under the brand name Veozah^TM. Fezolinetant reduces the number of hot flashes experienced during menopause.¹ Traditionally, physicians prescribe hormone replacement therapy (HRT) to treat hot flashes. The historic alternative to HRT is SSRIs (drugs used to treat depression and anxiety).²

Patients should review this guide before discussing fezolinetant with their healthcare provider. Patients should always discuss potential medication changes and additions with their prescribers.

How does fezolinetant work?

Fezolinetant blocks neurokinin receptors in the brain’s temperature control region.¹ This action prevents the body from overheating and causing hot flashes.³

How do I know if fezolinetant will decrease my hot flashes?

Two trials studied fezolinetant in menopausal women. The women experienced at least seven hot flashes per day before receiving fezolinetant.^4,5 Both trials saw significant reductions in hot flashes compared to placebo. The remaining hot flashes were less severe.^5,6 Of note, most women in the trials were white.⁵

Researchers conducted the MOONLIGHT trials to determine if fezolinetant helped menopausal Asian women. The MOONLIGHT trials had no significant improvements in hot flashes.⁷ This result suggests that fezolinetant may not help women of Asian descent.

Should I take fezolinetant instead of hormone replacement therapy (HRT)?

No trials directly compare fezolinetant to HRT. There is no evidence to suggest that one therapy is better than the other. Fezolinetant may be an option for patients that cannot receive hormone replacement therapy.

Who should not receive fezolinetant?

Fezolinetant is contraindicated in patients with known cirrhosis or severe kidney damage.¹ Patients taking medications that inhibit the CYP1A2 enzyme should not receive fezolinetant.¹ CYP1A2 inhibiting drugs include acyclovir, verapamil, allopurinol, duloxetine, famotidine (Pepcid^®), and many more.⁸ A pharmacist can determine if a patient takes a CYP1A2 inhibiting medication.

What side effects can occur while taking fezolinetant?

In clinical trials most side effects included headache, diarrhea, abdominal pain, and insomnia. An uncommon side effect was elevated liver enzymes. The elevation reversed after patients stopped taking the drug.¹

Concluding Thoughts

Patients who cannot receive HRT should consider fezolinetant to treat hot flashes. Patients need to discuss their options with their healthcare provider.

References

1. Veozah. Prescribing Information. Astellas Pharma US Inc. Accessed April 2, 2024. https://www.astellas.com/us/system/files/veozah_uspi.pdf
2. Khan SJ, Kapoor E, Faubion SS, Kling JM. Vasomotor symptoms during menopause: a practical guide on current treatments and future perspectives. Int J Womens Health. February 14, 2023;15:273-287. doi: 10.2147/IJWH.S365808. https://www.dovepress.com/vasomotor-symptoms-during-menopause-a-practical-guide-on-current-treat-peer-reviewed-fulltext-article-IJWH
3. Astellas Pharma Inc. Results from Astellas’ pivotal phase 3 SKYLIGHT 1^TM study of fezolinetant for vasomotor symptoms due to menopause published in The Lancet. PR Newswire. March 13, 2023. Accessed April 2, 2024. https://www.prnewswire.com/news-releases/results-from-astellas-pivotal-phase-3-skylight-1-study-of-fezolinetant-for-vasomotor-symptoms-due-to-menopause-published-in-the-lancet-301770807.html
4. A study to find out if fezolinetant helps reduce moderate to severe hot flashes in women going through menopause (Skylight 1). Clinicaltrials.gov identifier: NCT04003155. Updated September 1, 2023. Accessed December 1, 2023. https://clinicaltrials.gov/study/NCT04003155
5. Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab. 2023;108(8):1981-1997. doi: 10.1210/clinem/dgad058.
6. Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled trial. [ABSTRACT]. Lancet. 2023;401(10382): 1091-1102. doi: 10.1016/S0140-6736(23)00085-5. https://pubmed.ncbi.nlm.nih.gov/36924778/
7. Astellas announces topline 12-week results from phase 3 study of fezolinetant for the nonhormonal treatment of vasomotor symptoms in women in Asia. News Release. Astellas; March 15, 2022. https://www.astellas.com/en/news/25421
8. Interaction of Energy Drinks with Prescription Medication and Drugs of Abuse – Scientific Figure on ResearchGate. Accessed April 2, 2024. https://www.researchgate.net/figure/List-of-CYP1A2-substrates-inducers-and-inhibitors_tbl1_354787382