Veoza (fezolinetant): risk of drug-induced liver injury and new recommendations on monitoring of liver function before and during treatment.

Summary 

• Serious liver injury has been observed with fezolinetant. 
• Liver function tests (LFTs) must be performed prior to initiation of fezolinetant. Treatment with fezolinetant must not be initiated if serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) levels are ≥2x ULN or if total bilirubin levels are ≥2x ULN.
• During the first three months of treatment, monthly LFTs must be performed, and thereafter based on clinical judgement. LFTs must also be performed when symptoms suggestive of liver injury occur. 
• Treatment with fezolinetant must be discontinued if:
  • Transaminase elevations are ≥3x ULN with: total bilirubin >2x ULN OR if patients develop symptoms of liver injury;
  • Transaminase elevations >5x ULN.
• LFT monitoring should be maintained until LFTs have normalised.
• atients must be advised to immediately seek medical attention if they experience signs or symptoms that may suggest liver injury such as fatigue, pruritus, jaundice, dark urine, pale faeces, nausea, vomiting, decreased appetite and/or abdominal pain.