FDA Approves Levetiracetam for Partial-Onset, Myoclonic, and Primary Generalized Tonic-Clonic Seizures
The FDA has approved levetiracetam for the treatment of partial-onset seizures in patients as young as 1 month of age, and as adjunctive therapy for myoclonic seizures in juvenile myoclonic epilepsy in patients 12 years and older, and for primary generalized tonic-clonic seizures in idiopathic generalized epilepsy in patients 6 years and older. This approval provides a broad-spectrum antiepileptic option with specific dosing regimens across pediatric and adult populations, including weight-based dosing for children. The availability of an oral solution facilitates administration for pediatric patients, particularly those weighing 20 kg or less, with dosing requiring a calibrated measuring device.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. It is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. It is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
Levetiracetam is given orally with or without food. For partial-onset seizures: Adults (≥16 years) initiate at 500 mg twice daily, titrate by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily. Pediatric patients (1 month to <6 months) initiate at 7 mg/kg twice daily, titrate by 7 mg/kg twice daily every 2 weeks to 21 mg/kg twice daily. Pediatric patients (6 months to <4 years) initiate at 10 mg/kg twice daily, titrate by 10 mg/kg twice daily every 2 weeks to 25 mg/kg twice daily. Pediatric patients (4 years to <16 years) initiate at 10 mg/kg twice daily, titrate by 10 mg/kg twice daily every 2 weeks to 30 mg/kg twice daily. For myoclonic seizures in patients ≥12 years: Initiate at 500 mg twice daily, titrate by 500 mg twice daily every 2 weeks to 1500 mg twice daily. For primary generalized tonic-clonic seizures: Adults (≥16 years) initiate at 500 mg twice daily, titrate by 500 mg twice daily every 2 weeks to 1500 mg twice daily. Pediatric patients (6 years to <16 years) initiate at 10 mg/kg twice daily, titrate by 10 mg/kg twice daily every 2 weeks to 30 mg/kg twice daily. Use the oral solution for pediatric patients with body weight ≤20 kg; weight-based dosing with a calibrated measuring device is required. Dose adjustment is recommended for adult patients with impaired renal function.
For partial-onset seizures in pediatric patients 1 month to <6 months, the mean daily dose in the clinical trial was 35 mg/kg. For ages 6 months to <4 years, the mean daily dose was 47 mg/kg. For ages 4 years to <16 years, the mean daily dose was 44 mg/kg, with a maximum daily dose of 3000 mg. For myoclonic seizures in patients ≥12 years, the effectiveness of doses lower than 3000 mg/day has not been studied. For primary generalized tonic-clonic seizures in adults ≥16 years, the effectiveness of doses lower than 3000 mg/day has not been adequately studied. Trial data not available in label for other populations or efficacy outcomes.
Not reported in label.
Not reported in label.
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