Lacosamide, an anti-epileptic drug, is approved for the treatment of focal seizures in children >4 years and adults. Real-World therapeutic drug monitoring data was collected over an 8-year period, where lacosamide was used as an off-label medication in the understudied pediatric patient population between 1 month and 4 years of age. A population pharmacokinetic analysis was performed to describe the age-specific pharmacokinetics across this age group. A one-compartment model with linear elimination where clearance and volume of distribution were allometrically scaled for body weight, without any age-associated maturation functions could adequately describe this real-world data. Co-administered anti-epileptic drugs, phenobarbital and felbamate significantly increased lacosamide clearance. Simulations performed in virtual pediatric patients to explore age-associated dose requirements suggested that children 4 years with approved dosing recommendations.
Discuss challenges in pediatric pharmacotherapy
Identify the utility of Real-world data
Age-associated dose requirements of lacosamide in children where the drug is currently used off-label
Lacosamide dose adjustments in presence of adjunctive anti-epileptic drugs