HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciCeno safely and effectively. See full prescribing information for LuciCeno.

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

• The recommended initial dosage of LuciCeno 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.

•  LuciCeno can be taken whole or the tablets can be crushed. The crushed tablet can be mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube.

DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg×30 tablets/bottle

CONTRAINDICATIONS

• Hypersensitivity to cenobamate or any of the inactive ingredients in LuciCeno.

• 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 LuciCeno with other drugs that shorten the QT interval.

• Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation.

• Neurological Adverse Reactions: Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on LuciCeno. Concomitant use with other CNS depressants or alcohol may have additive effects.

• Withdrawal of Antiepileptic Drugs: LuciCeno should be gradually withdrawn to minimize the potential of increased seizure frequency.

ADVERSE REACTIONS

The most common adverse reactions in patients receiving LuciCeno (at least 10% for LuciCeno and more frequently than placebo) include somnolence, dizziness, fatigue, diplopia, and headache.

DRUG INTERACTIONS

• Phenytoin: Gradually decrease phenytoin dosage by up to 50%.

• Phenobarbital and Clobazam: Reduce dosage as needed when used concomitantly with LuciCeno.

• Lamotrigine, Carbamazepine: Increase dosage as needed when used concomitantly with LuciCeno.

• CYP2B6 and CYP3A Substrates: Increase dosage as needed when used concomitantly with LuciCeno.

• CYP2C19 Substrates: Reduce dosage as needed when used concomitantly with LuciCeno.

• Oral Contraceptives: Effectiveness of hormonal oral contraceptives may be reduced when administered concomitantly with LuciCeno. Women should use additional or alternative non-hormonal birth control.

USE IN SPECIFIC POPULATIONS

• Pregnancy: Based on animal data, may cause fetal harm.

• Renal Impairment: Use with caution and dosage reduction may be considered in patients with mild to moderate (CLcr 30 to < 90 mL/min) and severe (CLcr < 30 mL/min) renal impairment. Use not recommended in end-stage renal disease (CLcr < 15 mL/min) undergoing dialysis.

• Hepatic Impairment: Use with caution in patients with mild to moderate hepatic impairment; lower maximum dosage and additional dosage reduction may be considered. Use of LuciCeno in patients with severe hepatic impairment is not recommended.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.