Active Ingredient: Brivaracetam
Brivaracetam is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 50 milligrams brivaracetam, divided daily, 2 doses in total. Afterwards, oral, 100 milligrams brivaracetam, daily, 2 doses in total. The maximum allowed total dose is 200 milligrams brivaracetam daily.
Regimen B: Oral, 100 milligrams brivaracetam, divided daily, 2 doses in total. Afterwards, oral, 100 milligrams brivaracetam, daily, 2 doses in total. The maximum allowed total dose is 200 milligrams brivaracetam daily.
The physician should prescribe the most appropriate formulation and strength according to weight and dose.
The dose should be administered in two equally divided doses, approximately 12 hours apart.
The recommended starting dose is either 50 mg/day or 100 mg/day based on physician’s assessment of required seizure reduction versus potential side effects. Based on individual patient response and tolerability, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.
If patients missed one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time. This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring.
For patients from 16 years of age, if brivaracetam has to be discontinued, it is recommended that the dose is reduced gradually by 50 mg/day on a weekly basis. For patients below the age of 16 years, if brivaracetam has to be discontinued, it is recommended that the dose is reduced by a maximum of half the dose every week until a dose of 1 mg/kg/day (for patients with a body weight less than 50 kg) or 50 mg/day (for patients with body weight of 50 kg or more) is reached.
After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 20 mg/day is recommended.
For:
Regimen A: In case that patient weight is ≥ 50 kg, oral, 50 milligrams brivaracetam, divided daily, 2 doses in total. Afterwards, in case that patient weight is ≥ 50 kg, oral, 100 milligrams brivaracetam, divided daily, 2 doses in total. The maximum allowed total dose is 200 milligrams brivaracetam daily.
Regimen B: In case that patient weight is ≥ 20 kg and patient weight is ≤ 50 kg, oral, between 1 milligrams brivaracetam per kilogram of body weight and 2 milligrams brivaracetam per kilogram of body weight, divided daily, 2 doses in total. Afterwards, in case that patient weight is ≥ 20 kg and patient weight is ≤ 50 kg, oral, 2 milligrams brivaracetam per kilogram of body weight, divided daily, 2 doses in total. The maximum allowed total dose is 4 milligrams brivaracetam per kilogram of body weight daily.
Regimen C: In case that patient weight is ≥ 10 kg and patient weight is ≤ 20 kg, oral, between 1 milligrams brivaracetam per kilogram of body weight and 2.5 milligrams brivaracetam per kilogram of body weight, divided daily, 2 doses in total. Afterwards, in case that patient weight is ≥ 10 kg and patient weight is ≤ 20 kg, oral, 2.5 milligrams brivaracetam per kilogram of body weight, divided daily, 2 doses in total. The maximum allowed total dose is 5 milligrams brivaracetam per kilogram of body weight daily.
The dose should be administered in two equally divided doses, approximately 12 hours apart.
The recommended starting dose is 50 mg/day. Brivaracetam may also be initiated at 100 mg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.
The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2 mg/kg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 4 mg/kg/day.
The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2.5 mg/kg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 2.5 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 5 mg/kg/day.
If patients missed one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time. This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring.
For patients from 16 years of age, if brivaracetam has to be discontinued, it is recommended that the dose is reduced gradually by 50 mg/day on a weekly basis. For patients below the age of 16 years, if brivaracetam has to be discontinued, it is recommended that the dose is reduced by a maximum of half the dose every week until a dose of 1 mg/kg/day (for patients with a body weight less than 50 kg) or 50 mg/day (for patients with body weight of 50 kg or more) is reached.
After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 20 mg/day is recommended.
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