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Posology: Brivaracetam may be initiated with either intravenous or oral administration. When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained.
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. The dose should be administered in two equally divided doses, once in the morning and once in the evening. Based on individual patient response and tolerability, the dose may be adjusted in the dose range of 50 mg/day to 200 mg/day.
Brivaracetam solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible. There is no experience with twice daily intravenous administration of brivaracetam for a period longer than 4 days.
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: If brivaracetam has to be discontinued it is recommended to withdraw it gradually by 50 mg/day on a weekly basis. After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 20 mg/day is recommended.
Special populations: Elderly (65 years of age and above): No dose adjustment is needed in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
The clinical experience in patients ≥65 years is limited.
Renal impairment: No dose adjustment is needed in patients with impaired renal function (see Pharmacology: Pharmacokinetics under Actions). Brivaracetam is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data.
Hepatic impairment: Exposure to brivaracetam was increased in patients with chronic liver disease. A 50 mg/day starting dose should be considered. A maximum daily dose of 150 mg administered in 2 divided doses is recommended for all stages of hepatic impairment (see Precautions, and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of brivaracetam in children aged less than 16 years have not yet been established.
Currently available data are described in Adverse Reactions, and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Method of administration: Film-coated tablet: Brivaracetam film-coated tablets must be taken orally swallowed in whole with liquid and may be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).
Oral solution: Brivaracetam oral solution can be diluted in water or juice shortly before swallowing and may be taken with or without food (see Pharmacology: Pharmacokinetics under Actions). A nasogastric tube or a gastrostomy tube may be used when administering brivaracetam oral solution.
Solution for injection/infusion: Brivaracetam may be administered as an intravenous bolus without dilution.
Brivaracetam may be diluted in a compatible diluent and administered as a 15-minute intravenous infusion (see Special precautions for disposal and other handling under Cautions for Usage). This medicinal product must not be mixed with other medicinal products.
Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions; e.g. status epilepticus and is therefore not recommended for such conditions.
