Partial onset seizures with or without secondary generalisation

Active Ingredient: Brivaracetam

Indication for Brivaracetam

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 - 65 years old)
Therapeutic intent: Curative procedure

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:

50 or 100 mg/day and thereafter 100 mg/day

For:

Dosage regimens

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.

Detailed description

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.

Adults

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.

Missed doses

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.

Discontinuation

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.

50-200 mg/day for patients weighing ≥50 kg, 1-4 mg/kg/day for patients weighing 20-50 kg, 1-5 mg/kg/day for patients weighing <20 kg

For:

Dosage regimens

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.

Detailed description

The dose should be administered in two equally divided doses, approximately 12 hours apart.

Adolescents and children weighing 50 kg or more

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.

Adolescents and children weighing from 20 kg to less than 50 kg

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.

Children weighing from 10 kg to less than 20 kg

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.

Missed doses

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.

Discontinuation

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.

Active ingredient

Brivaracetam

Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells. Although the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of neurotransmitters.

Read more about Brivaracetam

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