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What are the hepatic monitoring requirements for fezolinetant?

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Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury, including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP) and total and direct serum bilirubin prior to fezolinetant initiation; perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy

  • Do not start fezolinetant if concentration of ALT or AST is ≥ 2 × upper limit of normal (ULN) or if the total bilirubin is ≥ 2 × ULN for the evaluating laboratory.1
  • If transaminase elevations > 3 × ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.1
  • Discontinue fezolinetant if transaminase elevations are > 5 × ULN, transaminase elevations are > 3 × ULN and total bilirubin is > 2 × ULN, or if patients experience signs or symptoms that may suggest liver injury.1
  • Advise patients to discontinue fezolinetant immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury.1

  • Signs or symptoms that may suggest liver injury include new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.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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