Generic Name and Formulations:
Perampanel 2mg, 4mg, 6mg, 8mg, 10mg, 12mg; tabs.

Company:
Eisai Pharmaceuticals
Indications for FYCOMPA:
Adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients ≥12 years of age.

Adult:
Initially 2mg/day at bedtime; may increase by 2mg/day in weekly increments to 4–12mg/day; max 12mg/day. Concomitant enzyme-inducing AEDs: initially 4mg/day at bedtime. Elderly or hepatic impairment: max frequency for dose increase is every two weeks; mild: max 6mg/day; moderate: max 4mg/day. Severe hepatic or renal impairment, hemodialysis: not recommended.

Children:
Not established.

Warnings/Precautions:
Increased risk of serious psychiatric and behavioral reactions (eg, aggression, hostility, irritability); monitor during treatment (esp. initial titration period or at higher doses) and one month after last dose; reduce dose or permanently discontinue if symptoms persist. Increased risk of suicidal thoughts or behavior; monitor for clinical worsening or unusual changes. Increased risk of neurologic effects (eg, dizziness, gait disturbance, somnolence, fatigue) or falls and injuries; monitor (esp. elderly). Avoid abrupt cessation. Elderly: titrate slowly. Pregnancy (Cat. C). Nursing mothers.

Interactions:
Antagonized by CYP450 inducers (eg, carbamazepine, phenytoin, oxcarbazepine, topiramate); monitor and may need dose adjustment. Avoid concomitant other strong CYP3A inducers (eg, rifampin, St. John’s wort). Antagonizes midazolam. Potentiates oxcarbazepine. Potentiated by ketoconazole. Caution with concomitant CNS depressants (eg, benzodiazepines, narcotics, barbiturates, sedating antihistamines) and alcohol. Reduces effectiveness of levonorgestrel (oral or implant contraceptives); use non-hormonal forms.

Pharmacological Class:
AMPA glutamate receptor antagonist.

Adverse Reactions:
Dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, gait disturbance, balance disorder; psychiatric reactions.

How Supplied:
Tabs—30, 90