Perampanel

Registered South African indications:

• Epilepsy

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding

Cautions

• Moderate to severe renal impairment
• Hepatic impairment
• Elderly
• Female patients of childbearing age
• History of substance abuse
• Galactose intolerance
• Lapp lactase deficiency 
• Glucose-galactose malabsorption
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Epilepsy (additional agent required)
- Partial onset seizures with or without secondarily generalised seizures

• Oral (tab): Initial: 2mg, dly at night; Titrate by 2mg/day at 2 week intervals; Maintenance: 4-8mg, dly at night; Max: 12mg/24hrs

Do not cut/crush/chew/dissolve

Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel should be titrated no more frequently than at 2-week intervals

Patients who are taking concomitant medicinal products that shorten the half-life of perampanel should be titrated no more frequently than at 1-week intervals

See additional prescribing points

Not established for use in children below 12 years

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Moderate: Caution; no dose adjustment recommended 
• Severe: Caution; no information available

Hepatic Impairment

• Mild to moderate: Caution; dose adjustment recommended
• Severe: Caution; no information available

Elderly

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Dizziness
• Somnolence
• Ataxia
• Dysarthria
• Balance disorder
• Irritability
• Aggression
• Anger
• Anxiety
• Confusional state
• Suicidal ideation
• Suicide attempt
• Fatigue

Gastrointestinal Disorders

• Nausea

Endocrine and Metabolic Disorders

• Decreased appetite
• Increased appetite
• Increased weight 

Musculoskeletal Disorders

• Back pain
• Gait disturbance
• Fall

Sensory Disorders

• Diplopia
• Blurred vision
• Vertigo

• Combined oral contraceptive
• Carbamazepine
• Clobazam
• Lamotrigine
• Oxcarbazepine
• Valproic acid
• CYP450 inducers
• Midazolam 
• CYP3A4 substrates
• CYP3A4 inhibitors
• Alcohol

• Weight
• Mental state

Withdrawal

• It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures. However, perampanel can be discontinued abruptly if absolutely needed

Missed doses

• Single missed dose: The patient should wait and take their next dose as scheduled
• If more than 1 dose has been missed, for a continuous period of less than 5 half-lives (3 weeks for patients not taking perampanel metabolism-inducing anti-epileptic drugs (AED), 1 week for patients taking perampanel metabolism-inducing AEDs, consideration should be given to re-start treatment from the last dose level
• If a patient has discontinued perampanel for a continuous period of more than 5 half-lives, it is recommended that initial dosing recommendations given above should be followed

Perampanel is a selective, non-competitive antagonist of the ionotropic alpha-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid (AMPA) glutamate receptor on post synaptic neurons. The precise mechanism of action is not fully understood.

Tablet 2mg

• Fycompa fct (Equity) originator

Tablet 4mg

• Fycompa fct (Equity) originator

Tablet 6mg

• Fycompa fct (Equity) originator

Tablet 8mg

• Fycompa fct (Equity) originator

Tablet 10mg

• Fycompa fct (Equity) originator

Tablet 12mg

• Fycompa fct (Equity) originator