Adverse Drug Reaction

Summary of safety profile

In all controlled and uncontrolled trials in patients with partial-onset seizures, 1,639 patients have received perampanel of whom 1,147 have been treated for 6 months and 703 for longer than 12 months.

In the controlled and uncontrolled study in patients with primary generalized tonic clonic seizures, 114 patients have received perampanel of whom 68 have been treated for 6 months and 36 for longer than 12 months.

Adverse reactions leading to discontinuation:

In the controlled Phase 3 partial-onset seizures clinical trials, the rate of discontinuation as a result of an adverse reaction was 1.7% (3/172), 4.2% (18/431) and 13.7% (35/255) in patients randomised to receive perampanel at the recommended doses of 4 mg, 8 mg and 12 mg/day, respectively, and 1.4% (6/442) in patients randomised to receive placebo. The adverse reactions most commonly (≥1% in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and somnolence.

In the controlled Phase 3 primary generalized tonic-clonic seizures clinical trial, the rate of discontinuation as a result of an adverse reaction was 4.9% (4/81) in patients randomised to receive perampanel 8 mg, and 1.2% (1/82) in patients randomised to receive placebo. The adverse reaction most commonly leading to discontinuation (≥2% in the perampanel group and greater than placebo) was dizziness.

Post-marketing use

Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with perampanel treatment.

Tabulated list of adverse reactions

In the table below, adverse reactions, which were identified based on review of the full Perampanel (Fycompa®) clinical studies safety database, are listed by System Organ Class and frequency. The following convention has been used for the classification of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).

Within each frequency category, adverse reactions are presented in order of decreasing seriousness.

System Organ
Class
Very
common
Common Uncommon Not known
Metabolism and nutrition
disorders
Decreased appetite
Increased appetite
Psychiatric disorders Aggression
Anger
Anxiety
Confusional state
Suicidal ideation, Suicide attempt, Hallucinations, Psychotic disorder
Nervous system
disorders
Dizziness
Somnolence
Ataxia
Dysarthria
Balance disorder
Irritability
Eye disorders Diplopia
Vision blurred
Ear and labyrinth
disorders
Vertigo
Gastrointestinal
disorders
Nausea
Skin and
subcutaneous
tissue disorders
Drug Reaction with
Eosinophilia and Systemic
Symptoms
(DRESS)*
Stevens – Johnson Syndrome
(SJS)*
Musculoskeletal and connective tissue disorders Back pain
General disorders Gait
disturbance
Fatigue
Investigations Weight
increased
Injury, poisoning and
procedural complications
Fall

 

Paediatric population

Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind studies for partial-onset seizures and primary generalised tonic-clonic seizures, the overall safety profile in adolescents was similar to that of adults, except for aggression, which was observed more frequently in adolescents than in adults.

Based on the clinical trial database of 180 paediatric patients exposed to perampanel from a multicentre, open label study, the overall safety profile in children was similar to that established for adolescents and adults, except for somnolence, irritability, aggression, and agitation which were observed more frequently in the paediatric study compared to studies in adolescents and adults.

Available data in children did not suggest any clinically significant effects of perampanel on growth and development parameters including body weight, height, thyroid function, insulin‑like growth factor‑1 (IGF‑1) level, cognition (as assessed by Aldenkamp‑Baker neuropsychological assessment schedule [ABNAS]), behaviour (as assessed by Child Behavior Checklist [CBCL]), and dexterity (as assessed by Lafayette Grooved Pegboard Test [LGPT]). However, long term effects [greater than 1 year] on learning, intelligence, growth, endocrine function, and puberty in children remain unknown.


Reporting of suspected adverse drug reactions
Please contact:
HI-Eisai Pharmaceutical, Inc.
+63 2 88875837 / +63 2 88875160 / +63 9088672236
Or Report to FDA Philippines: www.fda.gov.ph