Do patients need to taper off fezolinetant?

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In fezolinetant clinical trials, the last dose was administered without tapering

  • The safety and efficacy of fezolinetant was evaluated over 52 weeks in the Phase 3 trials SKYLIGHT 1, 2 (efficacy and safety) and 4 (safety).1–3 Dose increases and decreases were not allowed and the last dose of fezolinetant was administered without tapering.4 There was no evidence of a rebound effect on VMS in the three-week follow-up periods.4
  • In VMS patients, the effective half-life of fezolinetant is predicted to be 9.6 hours.4 

  1. 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 Endocr Metab. 2023;108(8):1981-1997. Available at: https://doi.org/10.1210/clinem/dgad058.

  2. 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 study. Lancet. 2023;401(10382):1091-1102. Available at: https://doi.org/10.1016/s0140-6736(23)00085-5.

  3. Neal-Perry G, Cano A, Lederman S, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstet Gynecol. 2023;141(4):737-747. Available at: https://doi.org/10.1097/aog.0000000000005114.

  4. Data on file.

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