Precautions of Fezolinetant

1 Hepatic Transaminase Elevation and Hepatotoxicity

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. 

Discontinue Fezolinetant if: 

• transaminase elevations are greater than 5 times the ULN. 

• transaminase elevations are greater than 3 times the ULN and the total bilirubin level is greater than 2 times  the ULN. 

If transaminase elevations greater than 3 times the ULN occur, perform more frequent follow-up hepatic laboratory  tests until resolution. 

Exclude alternative causes of hepatic laboratory test elevations.

from FDA，2024.08