Ontozry Tablets DHCP Letter
For Healthcare Professionals
10th June 2026 Direct Healthcare Professional Communication
Ontozry ▼ (cenobamate): new requirements for liver monitoring due to reports of severe liver injury.
Summary
• Cases of severe liver injury with hepatic failure have been reported in patients treated with Ontozry, many in the context of a polytherapy with other antiseizure medications.
• Liver function tests should be evaluated before initiation of Ontozry and liver function should be monitored during treatment as clinically indicated.
• Prompt clinical evaluation and liver function tests should be performed in patients presenting with signs or symptoms indicating liver injury.
• Patients should be advised to immediately seek medical attention if they experience signs or symptoms suggesting liver injury.
• If liver injury is suspected or detected, dose reduction or discontinuation of Ontozry should be considered.
