Perampanel Dosage

Usual Adult Dose for Seizures

Patients NOT Receiving Concomitant Enzyme-Inducing Antiepileptic Drugs (AEDs):
-Partial-Onset Seizures:
Initial Dose: 2 mg orally once a day at bedtime.
Maintenance Dose: 8 to 12 mg/day; some patients may respond to 4 mg/day.
-Primary Generalized Tonic-Clonic Seizures:
Initial Dose: 2 mg orally once a day at bedtime.
Maintenance Dose: 8 mg/day; if needed and tolerated, may increase up to 12 mg/day for patients requiring further seizure reduction.

Patients Receiving Concomitant Enzyme-Inducing AEDs:
Partial-Onset AND Primary Generalized Tonic-Clonic Seizures:
-Initial Dose: 4 mg orally once a day at bedtime.
-Maintenance Dose: Has not been established.
-Maximum Dose: Has not been established; the highest dose studied was 12 mg once a day.

Comments: May increase dosage by increments of 2 mg/day no more frequently than at weekly intervals.

Use: Adjunctive therapy in patients with epilepsy for treatment of partial-onset seizures with or without secondarily generalized seizures, and for primary generalized tonic-clonic seizures.

Usual Geriatric Dose for Seizures

Increase dosage no more than every 2 weeks during titration.

Usual Pediatric Dose for Seizures

Age 12 Years and Older:

Patients NOT Receiving Concomitant Enzyme-Inducing Antiepileptic Drugs (AEDs):
-Partial-Onset Seizures:
Initial Dose: 2 mg orally once a day at bedtime.
Maintenance Dose: 8 to 12 mg/day; some patients may respond to 4 mg/day.
-Primary Generalized Tonic-Clonic Seizures:
Initial Dose: 2 mg orally once a day at bedtime.
Maintenance Dose: 8 mg/day; if needed and tolerated, may increase up to 12 mg/day for patients requiring further seizure reduction.

Patients Receiving Concomitant Enzyme-Inducing AEDs:
Partial-Onset AND Primary Generalized Tonic-Clonic Seizures:
-Initial Dose: 4 mg orally once a day at bedtime.
-Maintenance Dose: Has not been established.
-Maximum Dose: Has not been established; the highest dose studied was 12 mg once a day.

Comments: May increase dosage by increments of 2 mg/day no more frequently than at weekly intervals.

Use: Adjunctive therapy in patients with epilepsy for treatment of partial-onset seizures with or without secondarily generalized seizures, and for primary generalized tonic-clonic seizures.

Renal Dose Adjustments

-Mild Renal Impairment: No adjustment recommended.
-Moderate Renal Impairment: Use with caution; consider slower dose titration based on clinical response and tolerability.
-Severe Renal Impairment: Not recommended.

Liver Dose Adjustments

Mild and Moderate Hepatic Impairment:
-Initial Dose: 2 mg orally once a day at bedtime.
-Maintenance Dose: Increase dosage by increments of 2 mg/day, no more frequently than every 2 weeks.
-Maximum Dose: 6 mg/day (Mild Hepatic Impairment); 4 mg/day (Moderate Hepatic Impairment)

Severe Hepatic Impairment: Not recommended.

Dose Adjustments

Dose adjustment may be necessary when enzyme-inducing AEDs are introduced or withdrawn from a patient's treatment regimen.

Precautions

US BOXED WARNING:
-Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression.
-Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality are observed during or after treatment.
-Closely monitor patients, particularly during the titration period and at higher doses.
-Reduce the dose if these symptoms occur, and immediately discontinue this drug if symptoms are severe or are worsening.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule III

Dialysis

-Hemodialysis: Not recommended.
-Peritoneal dialysis: Data not available.

Other Comments

Administration Advice:
-May take dose with or without food.
-Swallow tablets whole; do not chew, crush, or split.
-Individualize dosing based on clinical response and tolerability.
-In the event of a single missed dose, advise patients to skip that dose and take the next dose the following day as scheduled.
-Consult the manufacturer product information if more than 1 dose is missed.
-Oral suspension: Shake well before every administration; consult the manufacturer product information on instructions for using the provided adapter and graduated oral dosing syringe.

Storage Requirements:
-Discard any unused oral suspension 90 days after first opening the bottle.

General:
-Overdosage: Effects could be prolonged due to the long half-life of this drug; forced diuresis, dialysis, and hemoperfusion are unlikely to be of value due to the low renal clearance; there is no available specific antidote.

Monitoring:
-Psychiatric and behavioral reactions including hostility- and aggression-related adverse events, neuropsychiatric events, and homicidal ideation and/or threat (during treatment and at least 1 month after last dose)
-Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior (during treatment)
-Weight gain (during treatment)

Patient Advice:
-Avoid alcohol while taking this drug.
-Avoid potentially dangerous activities such as driving and operating machinery until you know how this drug affects you.
-If you are currently taking a hormonal form of birth control, talk to your healthcare provider about additional non-hormonal forms of birth control you should consider during treatment with this drug.