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Is hepatic monitoring with fezolinetant needed after 1 year?

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In total, women have taken fezolinetant for up to 52 weeks in Phase 3 clinical studies. Therefore there is currently insufficient data to provide guidance on liver function monitoring beyond 1 year

  • In the Phase 3 trial program, onset of transaminase elevations occurred at various timepoints throughout the study durations, with no apparent cluster of time to onset across the treatment groups, and there was no dominant pattern of rise and fall of the transaminase values.1
  • Treatment decisions are left to the clinical discretion of the prescriber based on institutional protocol, practice guidelines, and patient-specific characteristics and response.

  • In the Phase 3 trial program, liver enzyme elevations were typically transient and asymptomatic, and generally resolved while on treatment or after treatment interruption/discontinuation.1
  • No specific predisposing characteristics (such as body mass index, history of non-alcoholic fatty liver disease, history of non-alcoholic steatohepatitis, age, concomitant medications, or race/ethnicity) were identified that increased hepatic safety risk associated with fezolinetant treatment.1
  • In the post-marketing setting, cases of serious drug-induced liver injury occurred within 40 days of starting fezolinetant.2  Patients experienced elevated transaminases (up to 50 × upper limit of normal [ULN] at peak elevation), elevated alkaline phosphatase (up to 4 × ULN at peak elevation), and bilirubin (up to 5 × ULN at peak elevation). Patients reported a general sense of feeling unwell and symptoms of fatigue, nausea, pruritis, jaundice, pale feces, and dark urine. The patients’ signs and symptoms gradually resolved after discontinuation of fezolinetant.

  1. Kagan R, Cano A, Nappi RE, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2024. https://dx.doi.org/10.1007/s12325-024-03073-8.

  2. VEOZAH [package insert]. Northbrook, IL, USA: Astellas Pharma, Inc. Available at: https://www.astellas.com/us/system/files/veozah_uspi.pdf.

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