A drug-use evaluation of perampanel in a pediatric medical center
Purpose: Perampanel is an antiepileptic medication that was approved by the FDA in 2008 as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients aged 12 years and older. It acts as a non-competitive AMPA receptor antagonist on the postsynaptic neuron. Currently, there are no validated dosing recommendations for patients younger than the age of 12 years. The objective of this study is to evaluate outpatient prescribing of perampanel in patients less than 12 years old, compared to those 12 years or older, at Cincinnati Children’s Hospital Medical Center (CCHMC).
Methods: This study was approved by the CCHMC Institutional Review Board (IRB). Patients on perampanel for outpatient management of seizures were identified by the electronic medical record system utilized at CCHMC. The following data was be collected: patient age at initiation of perampanel, gender, race, weight, initial daily dose, maximum tolerated daily dose, dosing frequency, and adverse events. Milligram per kilogram per day (mg/kg/day) dosing was calculated from initial and maximum-tolerated total daily doses. Documented dose reductions were used to identify severe adverse events. Mg/kg/day dosing was be evaluated between the two groups based on tolerability of adverse events. Results from the data collected will be compared between patients less than 12 years of age and patients aged 12 and older.
Results: There were 8 patients that were involved in this study. In the group of patients less than 12 years of age, there 3 patients and 5 in the group aged 12 years and older. The average age and weight of the younger group was 6.3 years and 19.9 kg, compared to 17.2 years and 48.6 kg in the older group. The average initial daily dose in mg was similar in both groups at 5.3 mg and 5mg, however, the average mg/kg/day dose varied greatly from 0.27 mg/kg/day in the younger group, to 0.12 mg/kg/day in the older group. The maximum tolerated dose in mg was very different between the groups while the mg/kg/day maximum tolerated dose was more similar. Prescribing of twice daily dosing was present in 29.3% of prescriptions. Lastly, there were 5 total dose reductions due to intolerance of perampanel; 4 in the younger group and 1 in the older group.
Conclusions: Based on the results of this study, it can be concluded that pediatric dosing of perampanel is not well defined. At CCHMC, there is an increasing number of incorrect dosing regimens with twice daily dosing. Traditional dosing of perampanel may not be the safest in patients less than years of age. Due to the results of this study and the due to the low number of participants, a larger, more comprehensive study of perampanel in patients less than years old needs to be conducted to provide validated dosing recommendations for pediatric dosing.