A Study of Fycompa (Perampanel) in Korean Participants

Post-Marketing Surveillance of Fycompa in Korean Patients

The purpose of this post-marketing surveillance is to observe the following items regarding the safety profile of Fycompa (Perampanel) film-coated tablets and oral suspension in normal clinical practice setting: serious adverse event/adverse drug reaction profile, unexpected adverse event/adverse drug reaction profile, already known adverse drug reaction profile, non-serious adverse event profile and other information related to the product's safety and effectiveness.

Inclusion Criteria:

1. Participants with approved indication for Fycompa (Perampanel) in Korea as follows:

   • Monotherapy (film-coated tablets)

     o 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy

   • Adjunctive therapy (film-coated tablets & oral suspension)

     • 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
     • 7 years and older Primary generalized tonic-clonic seizures: therapy for treatment of primary generalized tonic-clonic seizures in participants with idiopathic generalized epilepsy

2. Participants who have written consent for use of personal and medical information for the study purpose

Exclusion Criteria:

1. Hypersensitivity to the active substance or to any of the excipients of this medicine
2. In case of Fycompa film-coated tablets, Fycompa tablets contains lactose; therefore, participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. In case of Fycompa oral suspension, Fycompa suspension contains sorbitol; therefore, participants with rare hereditary problems of fructose intolerance should not take this medicine.
3. Other participants judged to be inadequate to participate in the study by doctor