From the FDA Drug Label
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.
The recommended dosage and treatment protocol for Xcopri (cenobamate) in adults with partial-onset seizures is to start with an initial dose of 12.5 mg once daily, then titrate to a maintenance dose of 200 mg once daily. The maximum allowed dose is 400 mg once daily 1.
- Key points:
- Initial dose: 12.5 mg once daily
- Maintenance dose: 200 mg once daily
- Maximum dose: 400 mg once daily
- Important consideration: The recommended titration schedule should not be exceeded.
From the Research
The recommended dosage of Xcopri (cenobamate) for adults with partial-onset seizures is a gradual titration schedule starting with 12.5 mg once daily for the first two weeks, then increasing to 25 mg once daily for weeks 3-4, with further increments of 50 mg every two weeks until reaching a maximum daily maintenance dose of 400 mg/day, as supported by the most recent and highest quality study 2.
Key Considerations
- The dosage should be adjusted based on the patient's response and tolerance to the medication.
- For patients with moderate to severe hepatic impairment, a maximum dose of 200 mg daily is recommended.
- Discontinuation should also be gradual, typically reducing the dose by 50-100 mg weekly to prevent seizure worsening.
Mechanism of Action
- Xcopri works by enhancing inhibitory neurotransmission through a dual mechanism that includes positive modulation of GABA-A receptors and inhibition of persistent sodium currents in neurons.
Side Effects
- Common side effects include somnolence, dizziness, fatigue, and diplopia.
- The risk of drug reaction with eosinophilia and systemic symptoms (DRESS) is a concern, although the incidence is low, as reported in studies 3, 4.