Is Zoveli (levetiracetam) or Focale (levetiracetam) more effective for seizure management in a 13-year-old boy with autism?

Zoveli and Focale Are Identical—No Difference in Effectiveness

Both Zoveli and Focale are brand names for the same active pharmaceutical ingredient, levetiracetam, and therefore have identical effectiveness for seizure management in a 13-year-old boy with autism. The choice between these two products should be based solely on practical factors such as cost, insurance coverage, and availability, not efficacy.

Why These Products Are Equivalent

• Levetiracetam is the active drug in both formulations, and bioequivalence standards ensure that different brand names deliver the same therapeutic effect 1
• The FDA approval for levetiracetam as adjunctive therapy for partial onset seizures applies to all formulations containing the same active ingredient at equivalent doses 1

Levetiracetam Effectiveness in This Population

For a 13-year-old with epilepsy, levetiracetam demonstrates strong efficacy as adjunctive therapy:

• In pediatric patients ages 4-16 years with partial onset seizures, levetiracetam showed a 26.8% greater reduction in seizure frequency compared to placebo 1
• The responder rate (≥50% seizure reduction) in children was approximately 52%, compared to 25% with placebo 2
• The Number Needed to Treat for one additional child to respond is 4 (95% CI 3-7), meaning for every 4 children treated with levetiracetam, one additional child will achieve ≥50% seizure reduction compared to placebo 2

Recommended Dosing for This Patient

Treatment should be initiated at 20 mg/kg/day in two divided doses (10 mg/kg BID), with titration every 2 weeks by 20 mg/kg increments to the target dose of 60 mg/kg/day (30 mg/kg BID) 1

• For a 13-year-old weighing >40 kg, this typically translates to starting at 1000 mg/day (500 mg BID) and titrating to 3000 mg/day (1500 mg BID) 1
• The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied in this age group 1

Critical Consideration: Autism and Behavioral Side Effects

This patient's autism diagnosis requires heightened vigilance for behavioral adverse effects, which occur more frequently in children than adults:

• Behavioral changes occurred in 23% of children on levetiracetam versus 12% on placebo (RR 1.90; 99% CI 1.16-3.11) 2
• Acute psychosis has been reported in children within days to months of starting levetiracetam, with symptoms including hallucinations, agitation, and behavioral disturbances 3
• Children with pre-existing cognitive deficits or mild behavioral problems may be at higher risk for psychiatric side effects 3
• These behavioral effects are reversible upon discontinuation or dose reduction and typically occur early in treatment, even at low doses (<20 mg/kg/day) 4

Monitoring Protocol

Close monitoring during the first 3 months is essential:

• Assess for new or worsening behavioral symptoms at each dose escalation 4
• Monitor seizure frequency to evaluate therapeutic response 2
• If behavioral side effects emerge, consider dose reduction or discontinuation rather than continuing to target dose 3, 4

Alternative Considerations

• If behavioral side effects develop, valproate may be considered as an alternative, though it showed no significant benefit for irritability in one study of children with autism 5
• The 2014 practice parameter found no significant difference in global functioning or irritability with levetiracetam in children with autism spectrum disorder 5