FYCOMPA Dosage & Rx Info | Uses, Side Effects

Fycompa Generic Name & Formulations

Legal Class

CIII

General Description

Perampanel 2mg, 4mg, 6mg, 8mg, 10mg, 12mg; tabs.

Pharmacological Class

AMPA glutamate receptor antagonist.

How Supplied

Tabs—30, 90; Susp—340mL (w. dosing syringes and adapter)

Manufacturer

Catalyst Pharmaceuticals

Generic Availability

Mechanism of Action

Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation.

Fycompa Indications

Indications

Monotherapy or adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients ≥4yrs of age. Adjunctive treatment of primary generalized tonic-clonic seizures in patients ≥12yrs.

Fycompa Dosage and Administration

Adults and Children

Partial-onset: <4yrs: not established. ≥4yrs: initially 2mg/day at bedtime; may increase by 2mg/day no more than once per week to 4–12mg/day; max 12mg/day. Tonic-clonic: <12yrs: not established. ≥12yrs: initially 2mg/day at bedtime; may increase by 2mg/day no more than once per week to 8–12mg/day. Concomitant moderate or strong CYP3A4 inducers: initially 4mg/day at bedtime. Elderly or hepatic impairment: max frequency for dose increase is every 2 weeks; mild: max 6mg/day; moderate: max 4mg/day. Severe hepatic or renal impairment, hemodialysis: not recommended.

Fycompa Contraindications

Not Applicable

Fycompa Boxed Warnings

Boxed Warning

Serious psychiatric and behavioral reactions.

Fycompa Warnings/Precautions

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. Nursing mothers.

Fycompa Pharmacokinetics

Metabolism

Hepatic (CYP3A4/5). 95–96% serum protein bound.

Elimination

Fecal (48%), renal (22%). Half-life: 105 hours.

Fycompa Interactions

Interactions

Antagonized by moderate and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, oxcarbazepine, topiramate, rifampin, St. John’s wort); see Adult. Caution with concomitant CNS depressants (eg, benzodiazepines, narcotics, barbiturates, sedating antihistamines). Avoid alcohol. Reduces effectiveness of levonorgestrel-containing contraceptives; use additional non-hormonal form during and for 1 month after discontinuation.

Fycompa Adverse Reactions

Adverse Reactions

Dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, anxiety, gait disturbance, balance disorder; psychiatric reactions, CNS depression, DRESS/multiorgan hypersensitivity (discontinue if occurs).

Fycompa Clinical Trials

See Literature

Fycompa Note