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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
