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fezolinetant (Veozah)
Indications:
- vasomotor symptoms of menopause (FDA-approved May 2023) [2]
- improvement noted as early as 1 week & sustained through 40 weeks [3]
- effective in reducing moderate-to-severe vasomotor symptoms of menopause & sleep disturbances in postmenopausal women [4]
- 30mg & 45mg fezolinetant improved menopausal quality of life at 12 weeks [5]
Contraindications:
- cirrhosis
- chronic renal failure (severe)
Dosage:
- once or twice daily oral, 30 mg, 45 mg approved dose
Monitor:
- liver function tests at baseline & every 3 months for >= 9 months [3]
- stop if serum transaminases exceed 5 times the upper limit of normal or if serum transaminases exceed 3 times the upper limit of normal & total serum bilirubin is > 2 times the upper limit of normal
- more frequent liver function testing if the serum transaminases exceed 3 times the upper limit of normal, but the total serum bilirubin is < 2 times the upper limit of normal
Adverse effects:
- well tolerated during 52 weeks of follow up
- headache most common adverse effect [3]
- hepatotoxicity
- elevations in serum transaminases >= 3X upper limit of normal (< 2%) [3]
- resolution with termination of treatment
Mechanism of action:
- neurokinin-3 receptor antagonist
Notes:
- list price 2023 $550/month [3]
General
endocrine agent
receptor antagonist
Database Correlations
PUBCHEM cid=117604931
References
- Fraser GL, Lederman S, Waldbaum A et al.
A phase 2b, randomized, placebo-controlled, double-blind,
ose-ranging study of the neurokinin 3 receptor antagonist fezolinetant
for vasomotor symptoms associated with menopause.
Menopause 2020 Apr; 27:382
PMID: 32102086 Free PMC Article
https://journals.lww.com/menopausejournal/FullText/2020/04000/A_phase_2b,_randomized,_placebo_controlled,.4.aspx
- Splete H
FDA OKs New Drug for Hot Flashes
Medscape. May 12, 2023
https://www.medscape.com/viewarticle/991897
- O'Dwyer MC
New Nonhormonal Option for Vasomotor Symptoms of Menopause
NEJM Journal Watch. June 15, 2023
(subscription needed)
- Lederman S et al.
Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated
with menopause (SKYLIGHT 1): A phase 3 randomised controlled study.
Lancet 2023 Apr 1; 401:1091.
PMID: 36924778
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00085-5/fulltext
- Johnson KA 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 Feb 3; [e-pub].
PMID: 36734148
https://academic.oup.com/jcem/advance-article/doi/10.1210/clinem/dgad058/7025342
- Neal-Perry G et al.
Safety of fezolinetant for vasomotor symptoms associated with menopause:
A randomized controlled trial.
Obstet Gynecol 2023 Apr; 141:737.
PMID: 36897180 PMCID: PMC10026946 Free PMC article
https://journals.lww.com/greenjournal/Fulltext/2023/04000/Safety_of_Fezolinetant_for_Vasomotor_Symptoms.13.aspx
- Bonga KN, Mishra A, Maiti R et al
Efficacy and Safety of Fezolinetant for the Treatment of Menopause-Associated
Vasomotor Symptoms: A Meta-analysis.
Obstet Gynecol. 2024 Jan 16.
PMID: 38227939
- Cano A, Nappi RE, Santoro N, et al.
Fezolinetant impact on health-related quality of life for vasomotor symptoms due
to the menopause: Pooled data from SKYLIGHT 1 and SKYLIGHT 2 randomised controlled
trials.
BJOG. 2024 Feb 6
PMID: 38320967 Free article
- Monaco K
FDA Warning on Hot Flash Drug.
Clinicians should perform liver blood tests before and during Veozah treatment.
MedPage Today September 12, 2024
https://www.medpagetoday.com/obgyn/menopause/111922
- FDA Drug Safety Communication. Sept 12, 2024
FDA adds warning about rare occurrence of serious liver injury with use of Veozah
(fezolinetant) for hot flashes due to menopause.
Stop medicine if signs and symptoms of liver injury occur
https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due