fezolinetant (Veozah)
Jump to navigation
Jump to search
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]
Adverse effects
- well tolerated during 52 weeks of follow up
- headache most common adverse effect[3]
- elevations in serum transaminases >= 3X upper limit of normal (< 2%)[3]
- resolution with termination of treatment
Mechanism of action
Notes
- list price 2023 $550/month[3]
More general terms
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: https://www.ncbi.nlm.nih.gov/pubmed/32102086 Free PMC Article https://journals.lww.com/menopausejournal/FullText/2020/04000/A_phase_2b,_randomized,_placebo_controlled,.4.aspx
- ↑ 2.0 2.1 Splete H FDA OKs New Drug for Hot Flashes Medscape. May 12, 2023 https://www.medscape.com/viewarticle/991897
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/36897180 PMCID: PMC10026946 Free PMC article https://journals.lww.com/greenjournal/Fulltext/2023/04000/Safety_of_Fezolinetant_for_Vasomotor_Symptoms.13.aspx - ↑ 4.0 4.1 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: https://www.ncbi.nlm.nih.gov/pubmed/38227939
- ↑ 5.0 5.1 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: https://www.ncbi.nlm.nih.gov/pubmed/38320967 Free article