Generic name: PERAMPANEL 2mg; PERAMPANEL 4mg
Dosage form: tablets
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2.1 Dosing Information
In the Absence of Enzyme-Inducing AEDs
The recommended starting dosage of FYCOMPA is 2 mg once daily taken orally at bedtime. Increase dosage by 2 mg per day increments no more frequently than every week to a dose of 4 mg to 8 mg once daily taken at bedtime. In elderly patients, dosage increases during titration are recommended no more frequently than every two weeks.
The recommended dose range is 8 mg to 12 mg once daily. A dose of 12 mg once daily resulted in somewhat greater reductions in seizure rates than the dose of 8 mg once daily, but with a substantial increase in adverse reactions. Individual dosing should be adjusted based on clinical response and tolerability [see Clinical Studies (14)].
In the Presence of Enzyme-Inducing AEDs
The recommended starting dosage of FYCOMPA in the presence of enzyme-inducing AEDs, including phenytoin, carbamazepine, and oxcarbazepine, is 4 mg and patients should be monitored closely for response. Clinical trials revealed a substantially reduced effect on seizure rates in these patients. The reduction in seizure frequency was somewhat greater at 12 mg than at 8 mg. [see Clinical Studies (14)].
When these enzyme-inducing AEDs are introduced or withdrawn from a patient’s treatment regimen, patient should be closely monitored for clinical response and tolerability. Dose adjustment of FYCOMPA may be necessary.
2.2 Dosage Adjustments in Patients with Hepatic Impairment
Based on higher exposure and the longer half-life of perampanel in patients with mild and moderate hepatic impairment, dosage adjustment is recommended. Starting dose should be 2 mg per day with weekly increments of 2 mg per day every two weeks until target dose is achieved. The maximum recommended daily dose is 6 mg for patients with mild hepatic impairment and 4 mg for patients with moderate hepatic impairment. Dose increases in patients with mild and moderate hepatic impairment, as with all patients, should be based on clinical response and tolerability. Use in patients with severe hepatic impairment is not recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.3 Patients with Renal Impairment
FYCOMPA can be used in patients with moderate renal impairment with close monitoring. A slower titration may be considered based on clinical response and tolerability. Use in patients with severe renal impairment or patients undergoing hemodialysis is not recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].