The Clinical Efficacy and Safety of Acute Care Setting for Intravenous Levetiracetam (Focale) in Children

Abstract

Abstract Background Status epilepticus (SE) is a serious neurological emergency with a high mortality rate. Although levetiracetam is an effective antiepileptic drug for managing SE, its excessive cost may limit its accessibility. Focale, a more affordable generic version, is currently available and is more than 50% less expensive than the original version. However, there is currently no study on the efficacy and safety of Focale in pediatric patients with SE. Objective This study aimed to investigate the efficacy and safety of the antiepileptic drug, Focale, in pediatric patients. Materials and Methods This was a retrospective study that examined 131 pediatric patients younger than 18 years, who were treated with Focale for seizure control and prevention between June 2019 and November 2022. Results A total of 131 patients were included in the study, of which 73 (55.7%) were male. The age group with the highest frequency was 0 to 3 years old (28.2%). Focale was used with the following indications: (1) SE (45.04%), (2) acute repetitive convulsive seizures (22.14%), (3) primary prophylaxis (26.72%), (4) acute first seizure (1.52%), and (5) patients with epilepsy with nothing per oral (4.58%). Regarding the outcomes, the seizure-controlled rate in the seizure group was 81.1%, while the seizure prevention rate was 92.7% for those who received Focale as a seizure prophylaxis. Only 2 out of 131 patients had experienced adverse effects (1.5%). Conclusion The generic intravenous levetiracetam treatment had high seizure-controlled rate in patients with seizure attacks and seizure prevention rate in the seizure prophylaxis group in pediatric patients. Side effects of this regimen in pediatric patients were low.