HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use FYCOMPA ® safely and effectively. See full prescribing information for FYCOMPA ® .
FYCOMPA(perampanel)tablets , for oral use , CIII
FYCOMPA(perampanel) oral s uspension , CIII
Initial U.S. Approval: 20 12
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS See full prescribing information for complete 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 taking FYCOMPA (5.1)
Monitor patients for these reactions as well as for changes in mood, behavior, or personality that are not typical for the patient, particularly during the titration period and at higher doses (5.1)
FYCOMPA should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1.2) 06/2015
Dosage and Administration (2.7) 04/2016
INDICATIONS AND USAGE
FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated as adjunctive therapy for the treatment of:
Partial-Onset Seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older (1.1)
Primary Generalized Tonic-Clonic Seizures in patients with epilepsy 12 years of age and older (1.2)
DOSAGE AND ADMINISTRATION
Dosing in the absence of enzyme-inducing antiepileptic drugs (AEDs)
Starting dose: 2 mg once daily orally at bedtime (2.1, 2.2)
May increase dose based on clinical response and tolerability by increments of 2 mg once daily no more frequently than at weekly intervals (2.1, 2.2)
Recommended maintenance dose: Partial-Onset Seizures – 8 to 12 mg once daily at bedtime; Primary Generalized Tonic-Clonic Seizures – 8 mg once daily at bedtime (2.1, 2.2)
Individual dosing should be adjusted based on clinical response and tolerability
Measure oral suspension using provided adaptor and dosing syringe (2.7)
Dosing in the presence of concomitant enzyme-inducing AEDs: see section 2.3
Specific Populations
Mild and Moderate Hepatic Impairment: Maximum recommended daily dose is 6 mg (mild) and 4 mg (moderate) once daily at bedtime (2.4)
Severe Hepatic Impairment: Not recommended (2.4)
Severe Renal Impairment or on Hemodialysis: Not recommended (2.5)
Elderly: Increase dose no more frequently than every 2 weeks (2.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg (3)
Oral Suspension: 0.5 mg/mL (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior (5.2)
Neurologic Effects: Monitor for dizziness, gait disturbance, somnolence, and fatigue (5.3)
Patients should use caution when driving or operating machinery (5.3)
Falls: Monitor for falls and injuries (5.4)
Withdrawal of Antiepileptic Drugs: In patients with epilepsy, there may be an increase in seizure frequency (5.5)
ADVERSE REACTIONS
Most common adverse reactions (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irrit |
