Adult Dosing

Partial-onset seizures

• Start 2 mg PO qday at bedtime in patients not on enzyme-inducing anti-epileptic drugs and 4 mg PO in patients on enzyme-inducing anti-epileptic drugs
• May increase by 2 mg/day increments in at least weekly intervals to 4-8 mg PO qday at bedtime
• Maximum daily dose: 12 mg PO qday at bedtime
• Elderly patients: Maximum frequency for dosage increases is every 2 weeks

Pediatric Dosing

• Safety and effectiveness in pediatric patients <12 years old have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures

• Hypersensitivity to any of the ingredients of the product

• Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported with perampanel. Closely 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
• Reduce the dose if these symptoms occur and discontinue therapy immediately if symptoms are severe or are worsening

Renal Dose Adjustment

• Mild renal impairment: No dose adjustments
• Moderate renal impairment: Caution advised; slower titration may be considered
• Severe renal impairment or hemodialysis: Use not recommended

Hepatic Dose Adjustment

• Mild hepatic impairment: Max dose: 6 mg PO qday at bedtime; max frequency for dosage increases is q2wk
• Moderate hepatic impairment: Max dose: 4 mg PO qday at bedtime; max frequency for dosage increases is q2wk
• Severe hepatic impairment: Not recommended

• Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported with perampanel. Closely 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, but also through 37 weeks of treatment and at higher doses [US black box warning]
• Reduce the dose if these symptoms occur and discontinue therapy immediately if symptoms are severe or are worsening [US black box warning]
• Therapy has been associated with psychiatric events such as paranoia, euphoric mood, agitation, anger, mental status changes, and disorientation/confusional state
• Alcohol may significantly worsen mood and anger and should be avoided
• Levonorgestrel containing contraceptives may be rendered less effective, if using additional non-hormonal forms of contraception recommended
• Avoid use of strong CUP3A inducers, such as rifampin, St. Johns Wort
• Patients should be closely monitored during treatment and for at least one month after the last dose and especially when taking higher doses and during the initial few weeks of drug therapy or at other times of dose increases
• Patients, their caregivers, and families should be informed that perampanel may increase the risk of psychiatric events
• Antiepileptic drugs (AEDs), including perampanel have been associated with increase in risk of suicidal thoughts or suicidal behavior. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
• Therapy may lead to dizziness, disturbance in gait or coordination, balance disorder, ataxia, vertigo, somnolence, fatigue, asthenia, lethargy
• Patients should be advised against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery while on therapy
• Therapy may increase risk of falls, which may lead to serious injuries including head injuries and bone fracture; elderly patients may be at an increased risk
• Abrupt cessation of therapy may leas to increased seizure frequency in patients with seizure disorders. A gradual withdrawal is generally recommended with anti-epileptic drugs

Fycompa interacts with :

Contraceptives, Oral

Pregnancy Category:C

Breastfeeding: Perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses. Perampanel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

• CNS: Vertigo, dizziness, headache, paraesthesia, hypersomnia, somnolence, fatigue
• NEURO: Asthenia, ataxia, balance disorder, coordination abnormal, dysarthria, hypoaesthesia
• PSYCHIATRY: Aggression, anger, anxiety, confusional state, euphoric mood, irritability, mood altered
• EENT: Diplopia, blurred vision, oropharyngeal pain
• GI: Constipation, nausea, vomiting
• DERM: Contusion, skin laceration
• RESP: Upper respiratory tract infection, cough
• METABOLISM: Weight gain, hyponatremia
• MUSC: Arthralgia, back pain, musculoskeletal pain, myalgia, pain in extremity
• MISC: Falls, head injury, limb injury, peripheral edema

• Non-competitive AMPA glutamate receptor antagonist; 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
• Metabolism: Metabolized in liver via primary oxidation by CYP3A4 and/or CYP3A5 substrate and sequential glucuronidation
• Excretion: Feces (48%); urine (22%)
• Half-life: Approximately 105 hours

US Trade Name(s)

• Fycompa

US Availability

Fycompa

• TABS: 2, 4, 6, 8, 10, 12 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Fycompa

UK Availability

Fycompa

• TABS: 2, 4, 6, 8, 10, 12 mg

[Outline]

Neurologic

Anticonvulsants

Glutamate Antagonists