Cenobamate

What it is and how it works

Mechanism of Action The precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown. Cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABA A ) ion channel.

Mechanism class: Sodium Channel Antagonists · GABA A Receptor Positive Modulators · Cytochrome P450 2B6 Inhibitors

Indications

is indicated for the treatment of partial-onset seizures in adult patients. XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.

Dosage and administration (summary)

Prior to initiating XCOPRI, obtain serum transaminases (ALT and AST) and total bilirubin, if not recently available (i.e., within 3 months), to establish baseline liver function. ( 2.1 , 5.4 ) The recommended initial dosage of XCOPRI is 12.5 mg once daily, titrated to the recommended maintenance dosage of 200 mg once daily. The recommended titration schedule should not be exceeded. The maximum dosage is 400 mg once daily. Hepatic impairment: For patients with mild or moderate hepatic impairment, the maximum recommended dosage is 200 mg once daily. ( 2.3 , 8.7 , 12.3 ) XCOPRI can be taken whole or the tablets can be crushed.

Contraindications

is contraindicated in patients with: Hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI Familial Short QT syndrome Hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI. Familial Short QT syndrome.

Warnings and precautions

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Discontinue if no alternate etiology. QT Shortening: Use caution when administering XCOPRI with other drugs that shorten the QT interval Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation. Liver Injury: Clinically significant liver injury has occurred. Obtain serum transaminases (ALT and AST) and total bilirubin before initiating XCOPRI, and during treatment if clinically indicated.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as XCOPRI, during pregnancy.

Storage and supply

How Supplied XCOPRI tablets are supplied in the following configurations: Bottles; 30 count Strength NDC Number Tablet Description (Color, Shape, Markings) 25 mg 71699-025-30 Film coated round brown tablets with SK on one side and 25 on the other side 50 mg 71699-050-30 Film coated round yellow tablets with SK on one side and 50 on the other side 1…

Source: Cenobamate (Xcopri) — US FDA prescribing information, 2025-08-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.