What is the role of eslicarbazepine acetate (Aptiom) in the treatment of epilepsy?

Updated: Jan 28, 2020
  • Author: Juan G Ochoa, MD; Chief Editor: Selim R Benbadis, MD  more...
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Answer

Answer

Eslicarbazepine acetate (Aptiom) is a prodrug that is activated to eslicarbazepine (S-licarbazepine), the major active metabolite of oxcarbazepine. It is indicated as either adjunctive treatment or monotherapy for partial-onset seizures in adults and children 4 years and older.

The initial adult dose is 400 mg PO once daily for 1 week, then increased to 800 mg PO once daily (the recommended maintenance dose). Some patients may benefit from 1,200 mg/day (maximum dose). An increase to 1,200 mg/day should only be initiated after patients tolerate 800 mg/day for 1 week. For some patients, treatment may be initiated at 800 mg/day if the need for additional seizure reduction outweighs an increased risk of adverse reactions during initiation. It may be administered with or without food.

An increased dose may be needed if coadministered with CYP enzyme-inducing AEDs (eg, carbamazepine, phenytoin, phenobarbital, primidone). Dosage reduction is recommended with moderate-to-severe renal impairment (200 mg/day initially for 2 weeks, then increase to 400 mg/day).

In September 2017, FDA expanded indication for eslicarbazepine acetate (Aptiom) to include the treatment of partial-onset seizures (POS) in children and adolescents aged 4–17 years. The expanded approval for eslicarbazepine acetate was based on the FDA guidance that allows data extrapolation to support pediatric use. The efficacy and safety of monotherapy and adjunct therapy for adults with POS was previously established in 5 multicenter, randomized, controlled studies. This data also supported safety and tolerability of eslicarbazepine acetate for the treatment of pediatric patients with POS.

Common adverse effects (ie, >10%) include dizziness, somnolence, nausea, headache, and diplopia.


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