Recommended Dosing Regimen for Fycompa (Perampanel)
The recommended starting dosage of Fycompa (perampanel) is 2 mg once daily taken orally at bedtime, with dose increases of 2 mg once daily at weekly intervals based on clinical response and tolerability, up to a recommended maintenance dose of 8-12 mg once daily. 1
Initial Dosing and Titration
- Starting dose: 2 mg once daily at bedtime
- Titration schedule: Increase by 2 mg increments no more frequently than weekly
- Maintenance dose range:
- For partial-onset seizures: 8-12 mg once daily (though some patients may respond to 4 mg daily)
- For primary generalized tonic-clonic seizures: 8 mg once daily (may increase to 12 mg if needed and tolerated)
Special Population Considerations
Patients on Enzyme-Inducing Antiepileptic Drugs
- Starting dose: 4 mg once daily
- Titration: Increase by 2 mg increments no more frequently than weekly
- Maximum dose studied: 12 mg once daily
- Applies to patients taking moderate/strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, oxcarbazepine) 1
Hepatic Impairment
- Mild impairment:
- Start at 2 mg once daily
- Increase by 2 mg increments no more frequently than every 2 weeks
- Maximum dose: 6 mg daily
- Moderate impairment:
- Start at 2 mg once daily
- Increase by 2 mg increments no more frequently than every 2 weeks
- Maximum dose: 4 mg daily
- Severe impairment: Not recommended 1
Renal Impairment
- Moderate impairment: Can be used with close monitoring; consider slower titration
- Severe impairment or hemodialysis: Not recommended 1
Elderly Patients
- Use standard starting dose but increase dosage no more frequently than every 2 weeks during titration 1
Administration Guidelines
- Administer once daily at bedtime
- For oral suspension (0.5 mg/mL):
- Shake well before administration
- Use provided adapter and graduated oral dosing syringe
- Discard any unused suspension 90 days after first opening 1
Monitoring and Safety Considerations
- CNS effects: Monitor for dizziness, somnolence, fatigue, and irritability, which are the most common adverse effects 2
- Psychiatric effects: Monitor for changes in mood, behavior, or personality, particularly during titration and at higher doses 1
- Dose adjustment: If serious adverse effects occur, reduce dose or discontinue if symptoms are severe or worsening 1
Clinical Pearls
- The 12 mg dose provides somewhat greater seizure reduction than 8 mg but with substantially more adverse effects 1
- Perampanel has a long half-life (85-122 hours), allowing for once-daily dosing 3
- Perampanel is rapidly absorbed (median time to peak concentration 0.75-1.25 hours) but has slow elimination 3
- Most common adverse events are CNS-related (dizziness, somnolence) and dose-related, but typically mild to moderate in intensity 2
Perampanel's unique mechanism as a selective, noncompetitive AMPA receptor antagonist makes it a valuable option for drug-resistant epilepsy, with demonstrated efficacy for both partial-onset seizures and generalized tonic-clonic seizures 4.