The Italian Medicines Agency (AIFA) makes available a Direct Healthcare Professional Communication regarding the medicinal product Ontozry (cenobamate), concerning new requirements for liver monitoring.

Cases of severe hepatic injury, including hepatic failure, have been reported in in patients treated with cenobamate. Liver function tests should be evaluated before to initiation of treatment and should be monitored during treatment.

In the presence of signs or symptoms suggestive of hepatic injury, a prompt clinical evaluation and liver function tests should be performed, and a dose reduction or discontinuation of treatment should be considered. Patients should be advised to immediately seek medical attention if they experience signs or symptoms suggesting liver injury.

Further information is provided in the related document.

Healthcare professionals are reminded of the importance of reporting suspected adverse reactions to ensure continuous monitoring of drug safety and the protection of patient health.