Cenobamat is an antiepileptic drug indicated for the treatment of partial-onset seizures in adults. As a novel medication, its administration must be strictly in accordance with the doctor’s instructions, with close attention paid to relevant safety risks and monitoring requirements.

What are the Precautions for Cenobamat Administration?

Contraindications

Cenobamat is contraindicated in patients with a known hypersensitivity to cenobamat or any of its excipients.

The drug is contraindicated in patients with familial short QT syndrome, as it may shorten the QT interval and increase the risk of arrhythmia.

Patients with Hepatic or Renal Impairment

For patients with mild to moderate hepatic impairment, the maximum recommended daily dose is 200 mg. The drug is not recommended for patients with severe hepatic impairment.

Patients with mild to moderate renal impairment should use the drug with caution, and dose adjustment may be considered. The drug is not recommended for patients with end-stage renal disease.

Pregnancy and Lactation

Use during pregnancy may pose risks to the fetus. Effective contraceptive measures are recommended during treatment. If pregnancy occurs, the doctor should be informed immediately.

The safety of cenobamat use during lactation has not been established, and the potential benefits and risks should be carefully weighed.

Drug Interactions

It may decrease the plasma concentrations of lamotrigine and carbamazepine, and dose escalation of these drugs may be required as appropriate.

It may increase the plasma concentrations of phenytoin and phenobarbital, and dose reduction of these drugs may be required as appropriate.

It may reduce the efficacy of oral contraceptives, and additional or alternative non-hormonal contraceptive measures are recommended.

Monitoring for Cenobamat Administration

Clinical Monitoring

Regular follow-up: Close observation for hypersensitivity reactions, mood changes, neurological symptoms, etc., is required, especially during the initial treatment phase and dose adjustment period.

Electrocardiogram (ECG) monitoring: For patients at risk of cardiac diseases or co-administered with other drugs that may affect the QT interval, regular ECG monitoring is recommended.

Laboratory Monitoring

Blood routine and liver enzymes: If symptoms such as fever, skin rash, or fatigue occur during treatment, blood routine, eosinophil count, and liver function tests should be performed to alert against the occurrence of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Serum potassium level: Hyperkalemia may occur in some patients, so regular monitoring of electrolytes is necessary.

Patient Self-monitoring and Education

Patients should be aware of the symptoms of potential severe adverse reactions (e.g., skin rash, fever, palpitations, depression) and report them to the doctor promptly.

Alcohol consumption and concurrent use of other central nervous system depressants should be avoided during treatment to prevent exacerbation of adverse reactions such as somnolence and dizziness.

The drug must be taken strictly as prescribed by the doctor; the dose should not be adjusted or the drug discontinued abruptly without medical advice.