At what transaminase levels should fezolinetant be discontinued?

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Discontinue fezolinetant if transaminase elevations are > 5 × the upper limit of normal (ULN) or transaminase elevations are > 3 × ULN and total bilirubin is > 2 × ULN, or if patients experience signs or symptoms that may suggest liver injury

  • Signs and symptoms suggestive of liver injury include new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.1

  • Elevations in serum transaminase concentrations > 3 × ULN occurred in the phase 3 clinical trials.1
    • Women with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations were generally asymptomatic.1 Transaminase levels returned to pretreatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation.
  • In the post-marketing setting, cases of serious drug-induced liver injury occurred within 40 days of starting fezolinetant.1 Patients experienced elevated transaminases (up to 50 × ULN at peak elevation), elevated alkaline phosphatase (ALP; 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.
  • If transaminase elevations > 3 × ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.1
  • Exclude alternative causes of hepatic laboratory test elevations.1
  • Fezolinetant is contraindicated in women with known cirrhosis.1

  1. 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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