The Food and Drug Administration has issued a Drug Safety Communication to warn of a rare but serious drug-induced liver injury that may occur with the use of fezolinetant. The FDA is recommending that liver function tests (LFTs) be performed at baseline and that therapy not be started if total bilirubin, ALT, or AST level is 2 or more times the upper limit of normal (ULN) at baseline. In addition, LFTs should be performed monthly for the first three months, then at 6 and 9 months after starting therapy, and more frequently if transaminase levels are greater than three times the ULN. Fezolinetant should be discontinued if transaminase levels are greater than 5 times the ULN, or greater than 3 times the ULN with total bilirubin level greater than 2 times the ULN. Other causes of elevated LFTs should be excluded.

Patients should be monitored for and taught to report signs and symptoms of liver toxicity, including nausea, vomiting, itching, light-colored stools, jaundice, dark urine, abdominal swelling, or pain in the right-upper abdomen. Fezolinetant should be discontinued if signs and symptoms of liver toxicity occur.

Adverse effects from the use of fezolinetant should be reported to the FDA s MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: November 2024

Nursing Drug Handbook

2024 Wolters Kluwer
 

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