Fycompa Dosage

Generic name: perampanel
Dosage form: tablets

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2.1 Partial-Onset Seizures

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 increments of 2 mg no more frequently than at weekly intervals to a dose of 4 mg to 12 mg once daily taken at bedtime.

The recommended dose range is 4 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 once daily taken at bedtime. Increase dosage by increments of 2 mg no more frequently than at weekly intervals, and monitor patients closely for response. Clinical trials revealed a substantially reduced effect on seizure rates in these patients. The recommended dose range is 4 mg to 12 mg once daily. The reduction in seizure frequency was somewhat greater at 12 mg than at 8 mg. Individual dosing should be adjusted based on clinical response and tolerability [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When these enzyme-inducing AEDs are introduced or withdrawn from a patient’s treatment regimen, patient should be closely monitored for clinical response and tolerability.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 Primary Generalized Tonic-Clonic Seizures

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 increments of 2 mg no more frequently than at weekly intervals up to a dose of 8 mg once daily taken at bedtime. For subjects who are tolerating the drug well at 8 mg once daily and require further seizure control, some may benefit from a dose increase up to 12 mg once daily. 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. Increase dosage by increments of 2 mg no more frequently than at weekly intervals up to a dose of 12 mg once daily taken at bedtime. Patients should be monitored closely for response. The clinical study revealed a substantially reduced effect on seizure rates in these patients [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.

2.3 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. Increase dosage by increments of 2 mg no more frequently than every 2 weeks.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)].

2.4 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)].

2.5 Elderly Patients

In elderly patients, dosage increases during titration are recommended no more frequently than every 2 weeks [see Use in Specific Populations (8.5)].

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