PERAMPANEL TAB
Clinical Criteria Summary
Exclusion Criteria
- Preexisting aggression, hostility, irritability, anger, homicidal ideation and threats that is uncontrolled/untreated
- Severe hepatic impairment (Child Pugh Class C)
- CrCL 10-30 ml/min or on hemodialysis
Inclusion Criteria
- Medication management by a VA Neurologist or VA purchased Neurology care
- Inadequate response, intolerable side effects, or contraindication to two formulary antiepileptic medications for partial seizures (carbamazepine, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, divalproex sodium, topiramate, zonisamide) or primarily generalized seizures (lamotrigine, levetiracetam, topiramate, valproate, zonisamide)
Special Populations & Pregnancy
- Category C for women of childbearing potential
- Adverse events observed in animal reproduction studies
- Limited information on use in pregnancy; if inadvertent exposure occurs, close monitoring of the mother and fetus/newborn is recommended
Dosage & Administration
- Without enzyme-inducing AEDs: Starting dose 2 mg once daily at bedtime. Titrate by increments of 2 mg once daily no more frequently than weekly intervals based on clinical response and tolerability. Recommended maintenance: Partial-Onset Seizures 8 to 12 mg once daily; Primary Generalized Tonic-Clonic Seizures 8 mg once daily.
- With enzyme-inducing AEDs (phenytoin, carbamazepine, oxcarbazepine): Starting dose 4 mg once daily at bedtime. Titrate by increments of 2 mg once daily no more frequently than weekly intervals. Maintenance dose not established; highest studied dose is 12 mg once daily.
Monitoring & Safety Considerations
- Black box warning for serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger and homicidal ideation and threats (occurs regardless of prior psychiatric history or concomitant medications)
- Increased risk of suicidal thoughts or behavior; monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
- Avoid strong CYP3A4 inducers (rifampin, St. John's wort)
- Effectiveness of hormonal contraceptives containing levonorgestrel may decrease with 12 mg once daily dose
- Concomitant enzyme-inducing antiepileptics may compromise perampanel efficacy