Active Ingredient: Perampanel
Perampanel is indicated for the adjunctive treatment of partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 2 milligrams perampanel, once daily, over the duration of 1 to 2 weeks. Afterwards, oral, between 4 milligrams perampanel and 12 milligrams perampanel, once daily. The maximum allowed total dose is 12 milligrams perampanel daily.
Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset seizures.
Treatment with perampanel should be initiated with a dose of 2 mg/day. The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day. Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased by increments of 2 mg/day to 12 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel should be titrated no more frequently than at 1-week intervals.
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures. However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.
Single missed dose: As perampanel has a long half-life, the patient should wait and take their next dose as scheduled.
If more than 1 dose has been missed, for a continuous period of less than 5 half-lives (3 weeks for patients not taking perampanel metabolism-inducing anti-epileptic drugs (AED), 1 week for patients taking perampanel metabolism-inducing AEDs), consideration should be given to re-start treatment from the last dose level.
If a patient has discontinued perampanel for a continuous period of more than 5 half-lives, it is recommended that initial dosing recommendations given above should be followed.
Clinical studies of perampanel in epilepsy did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Analysis of safety information in 905 perampanel-treated elderly patients (in double-blind studies conducted in non-epilepsy indications) revealed no age-related differences in the safety profile. In combination with the lack of age-related difference in perampanel exposure, the results indicate that dose-adjustment in the elderly is not required. Perampanel should be used with caution in elderly taking into account the drug interaction potential in polymedicated patients.
Perampanel should be taken as single oral dose at bedtime.
For:
Regimen A, in the case that patient age in years is ≥ 4 and patient weight is ≥ 30 kg :
Oral, 2 milligrams perampanel, once daily at the end of the day, over the duration of 1 to 2 weeks. Afterwards, oral, between 4 milligrams perampanel and 12 milligrams perampanel, once daily at the end of the day. The maximum allowed total dose is 12 milligrams perampanel daily.
Regimen B, in the case that patient age in years is ≥ 4 and patient weight is ≥ 20 kg and patient weight is < 30 kg :
Oral, 1 milligrams perampanel, once daily at the end of the day, over the duration of 1 to 2 weeks. Afterwards, oral, between 4 milligrams perampanel and 8 milligrams perampanel, once daily at the end of the day. The maximum allowed total dose is 8 milligrams perampanel daily.
Regimen C, in the case that patient age in years is ≥ 4 and patient weight is < 20 kg :
Oral, 1 milligrams perampanel, once daily at the end of the day, over the duration of 1 to 2 weeks. Afterwards, oral, between 2 milligrams perampanel and 6 milligrams perampanel, once daily at the end of the day. The maximum allowed total dose is 6 milligrams perampanel daily.
Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset seizures.
The following table summarises the recommended posology for adults, adolescents and children from 4 years of age. More details are provided below the table.
| Adult/adolescent (12 years and older) | Children (4 – 11 years); weighing: | |||
| ≥30 kg | 20 - <30 kg | <20 kg | ||
| Recommended starting dose | 2 mg/day | 2 mg/day | 1 mg/day | 1 mg/day |
| Titration (incremental steps) | 2 mg/day (no more frequently than weekly intervals) | 2 mg/day (no more frequently than weekly intervals) | 1 mg/day (no more frequently than weekly intervals) | 1 mg/day (no more frequently than weekly intervals) |
| Recommended maintenance dose | 4 – 8 mg/day | 4 – 8 mg/day | 4 – 6 mg/day | 2 – 4 mg/day |
| Titration (incremental steps) | 2 mg/day (no more frequently than weekly intervals) | 2 mg/day (no more frequently than weekly intervals) | 1 mg/day (no more frequently than weekly intervals) | 0.5 mg/day (no more frequently than weekly intervals) |
| Recommended maximum dose | 12 mg/day | 12 mg/day | 8 mg/day | 6 mg/day |
Treatment with perampanel should be initiated with a dose of 2 mg/day. The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day. Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased by increments of 2 mg/day to 12 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel should be titrated no more frequently than at 1-week intervals.
Treatment with perampanel should be initiated with a dose of 1 mg/day. The dose may be increased based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 6 mg/day. Depending upon individual clinical response and tolerability at a dose of 6 mg/day, the dose may be increased by increments of 1 mg/day to 8 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel should be titrated no more frequently than at 1-week intervals.
Treatment with perampanel should be initiated with a dose of 1 mg/day. The dose may be increased based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 2 mg/day to 4 mg/day. Depending upon individual clinical response and tolerability at a dose of 4 mg/day, the dose may be increased by increments of 0.5 mg/day to 6 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel should be titrated no more frequently than at 1-week intervals.
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures. However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.
Single missed dose: As perampanel has a long half-life, the patient should wait and take their next dose as scheduled.
If more than 1 dose has been missed, for a continuous period of less than 5 half-lives (3 weeks for patients not taking perampanel metabolism-inducing anti-epileptic drugs (AED), 1 week for patients taking perampanel metabolism-inducing AEDs), consideration should be given to re-start treatment from the last dose level.
If a patient has discontinued perampanel for a continuous period of more than 5 half-lives, it is recommended that initial dosing recommendations given above should be followed.
Perampanel should be taken as single oral dose at bedtime.
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