Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
Briviact 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.
The physician should prescribe the most appropriate formulation and strength according to weight and dose.
The recommended posology for adults, adolescents and children from 2 years of age is summarised in the following table. The dose should be administered in two equally divided doses, approximately 12 hours apart.
| Recommended starting dose | Recommended maintenance dose | Therapeutic dose range* |
|---|---|---|
| Adolescents and children weighing 50 kg or more, and adults | ||
| 50 mg/day (or 100 mg/day)** | 100 mg/day | 50-200 mg/day |
| Adolescents and children weighing from 20 kg to less than 50 kg | ||
| 1 mg/kg/day (up to 2 mg/kg/day)** | 2 mg/kg/day | 1–4 mg/kg/day |
| Children weighing from 10 kg to less than 20 kg | ||
| 1 mg/kg/day (up to 2.5 mg/kg/day)** | 2.5 mg/kg/day | 1–5 mg/kg/day |
* Based on individual patient response, the dose may be adjusted within this effective dose range.
** Based on physician’s assessment of need for seizure control
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.
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.
No dose adjustment is needed in elderly patients (see section 5.2). The clinical experience in patients ≥65 years is limited.
No dose adjustment is needed in patients with impaired renal function (see section 5.2). Brivaracetam is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data.
Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function. No clinical data are available in paediatric patients with renal impairment.
Exposure to brivaracetam was increased in adult patients with chronic liver disease. In patients with hepatic impairment, the following adjusted doses, administered in 2 divided doses, approximately 12 hours apart, are recommended for all stages of hepatic impairment (see sections 4.4 and 5.2). No clinical data are available in paediatric patients with hepatic impairment.
| Age and body weight | Recommended starting dose | Recommended maximum daily dose |
|---|---|---|
| Adolescents and children weighing 50 kg or more, and adults | 50 mg/day | 150 mg/day |
| Adolescents and children weighing from 20 kg to less than 50 kg | 1 mg/kg/day | 3 mg/kg/day |
| Children weighing from 10 kg to less than 20 kg | 1 mg/kg/day | 4 mg/kg/day |
The efficacy of brivaracetam in paediatric patients aged less than 2 years has not yet been established. Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Brivaracetam film-coated tablets must be taken orally and swallowed in whole with liquid and may be taken with or without food (see section 5.2). Patients not being able to swallow tablets in whole or patients for whom the dose can not be met with the use of whole tablets should use Briviact 10 mg/ml oral solution.
There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam.
The following adverse reactions were reported with brivaracetam overdose: nausea, vertigo, balance disorder, anxiety, fatigue, irritability, aggression, insomnia, depression, and suicidal ideation in the post-marketing experience. In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions.
There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include general supportive measures. Since less than 10% of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance (see section 5.2).
4 years.
This medicinal product does not require any special storage conditions.
Briviact 10 mg film-coated tablets:
Briviact 25 mg film-coated tablets:
Briviact 50 mg film-coated tablets:
Briviact 75 mg film-coated tablets:
Briviact 100 mg film-coated tablets:
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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