New warning on hepatotoxicity risk for Veoza (fezolinetant)

Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 16 October 2025.

 

Summary

New warnings on hepatotoxicity risk and monitoring recommendations have been added to the Product Information (PI) for Veoza (fezolinetant).

The TGA undertook a review after the pharmaceutical company Astellas notified the TGA of an analysis of their global safety database, including postmarketing cases of hepatotoxicity. The TGA then worked with them to update the Australian Product Information.

Fezolinetant is used to treat moderate to severe vasomotor symptoms associated with menopause. These symptoms include sudden feelings of warmth (hot flashes) and sweating (night sweats) that occur when the body's temperature regulation system malfunctions.

What health professionals should do

Be alert to the new advice as described in 'Updates to the PI' below.

Advise patients that if they experience signs or symptoms that may suggest hepatotoxicity, they should discontinue Veoza immediately and seek medical attention including hepatic laboratory tests. Such symptoms include new-onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale faeces, dark urine or abdominal pain.

Perform follow-up evaluation of hepatic function monthly for the first 3 months after initiating Veoza, then at 6 months and 9 months, and thereafter periodically based on clinical judgement.

See the full article on the TGA website.