Can patients with elevated hepatic enzymes be started on fezolinetant? Can patients with elevated hepatic enzymes be restarted on fezolinetant?

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Answer: Do not start fezolinetant if the concentration of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is ≥ 2 × upper limit of normal (ULN) or if the total bilirubin is elevated (for example, ≥ 2 x ULN) for the evaluating laboratory. If baseline hepatic transaminase evaluation is < 2 × ULN and total bilirubin is normal, fezolinetant can be started. Fezolinetant is contraindicated in women with known cirrhosis
  • Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury (including serum ALT, serum AST, serum alkaline phosphatase, 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 while on therapy.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:
    • New onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.1
  • Astellas does not provide specific treatment recommendations on the management of transaminase elevation while on fezolinetant therapy beyond the guidance provided in the product label, and has not specifically studied restarting treatment after discontinuation; treatment decisions are left to the clinical discretion of the prescriber based on institutional protocol, practice guidelines, and patient-specific characteristics and response.

  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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