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Take a single 45 mg Fezolinetant tablet orally once daily with or without food.
Take Fezolinetant with liquids and swallow whole. Do not cut, crush, or chew tablets.
Administer Fezolinetant orally at about the same time each day. If a dose of Fezolinetant is missed or not taken at the usual time, administer the missed dose as soon as possible, unless there is less than 12 hours before the next scheduled dose. Return to the regular schedule the following day.
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 serum bilirubin (total and direct)] before initiating treatment with Fezolinetant. Do not start Fezolinetant if the concentration of ALT or AST is equal to or exceeds 2 times the upper limit of normal (ULN) or if the total bilirubin is elevated (for example, equal to or exceeds 2 times the ULN) for the evaluating laboratory. If baseline hepatic transaminase evaluation is less than 2 times the ULN and the total bilirubin is normal, Fezolinetant can be started.
While using Fezolinetant, perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy.
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.
from FDA，2024.08
