Partial onset seizures

Antiseizure Agent, Miscellaneous

Absorption
Oral: Rapidly and almost completely absorbed; delayed by 3 hours with a high-fat meal

Distribution
1. Vd:0.5 L/kg
2. Protein binding: ≤20% to plasma proteins

Metabolism
Hepatic and extrahepatic amidase mediated hydrolysis of the amide moiety to form carboxylic acid metabolite (primary route) and hydroxylation primarily by CYP2C19 to form the hydroxy metabolite (secondary route). Metabolites are inactive, including an additional hydroxy acid metabolite.

Excretion
Urine (>95%; <10% unchanged); feces(<1%)

Pharmakodynamics
1. Half-life Elimination:≈ 9 hours

Hypersensitivity to brivaracetam or any component of the formulation

Adverse events have been observed in animal reproduction studies.

It is not known if brivaracetam is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Common(>10%):
Nervous system: Dizziness (12%), drowsiness (?16%), psychiatric disturbance (13%; includes psychotic and nonpsychotic), sedated state (?16%)

1% to 10%:
Gastrointestinal: Constipation (2%), dysgeusia (≥3%), nausea (≤5%), vomiting (≤5%)
Hematologic & oncologic: Decreased white blood cell count (2%)
Local: Infusion site pain (≥3%)
Nervous system: Ataxia (≤3%), balance impairment (≤3%), euphoria (≥3%), fatigue (9%), intoxicated feeling (≥3%), irritability (3%)
Ophthalmic: Nystagmus disorder (≤3%)

Post marketing:
Hypersensitivity: Angioedema、Respiratory: Bronchospasm

Partial onset seizures (monotherapy or adjunctive therapy):
Oral, IV: Initial: 50 mg twice daily; may decrease to 25 mg twice daily or increase up to 100 mg twice daily based on individual patient response and tolerability (maximum: 200 mg/day).

Discontinuation of therapy:
educe gradually; it has been recommended to reduce the dose by 50 mg/day on a weekly basis with the final week of treatment at the dose of 20 mg/day.

Infants, Children, and Adolescents <16 years:
<11 kgs: Oral, IV: Initial: 0.75 to 1.5 mg/kg/dose twice daily; adjust dose based on individual patient response and tolerability (gradual dose escalation not required); maximum daily dose: 6 mg/kg/day in 2 divided doses.

11 kg to <20 kg: Oral, IV: Initial: 0.5 to 1.25 mg/kg/dose twice daily; adjust dose based on individual patient response and tolerability (gradual dose escalation not required); maximum daily dose: 5 mg/kg/day in 2 divided doses.

20 kg to <50 kg: Oral, IV: Initial: 0.5 to 1 mg/kg/dose twice daily; adjust dose based on individual patient response and tolerability (gradual dose escalation not required); maximum daily dose: 4 mg/kg/day in 2 divided doses.

≥50 kg: Oral, IV: Initial: 25 to 50 mg twice daily; adjust dose based on individual patient response and tolerability (gradual dose escalation not required); maximum daily dose: 200 mg/day in 2 divided doses.

Mild to severe impairment: No dosage adjustment necessary.
End-stage renal disease requiring dialysis: Use is not recommended (has not been studied).

Mild to severe impairment (Child Pugh classes A, B, and C): Initial: 25 mg twice daily, up to a maximum of 75 mg twice daily.