Briviact Dosage/Direction for Use

Posology: The physician should prescribe the most appropriate formulation and strength according to weight and dose.
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.
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.
Film-coated tablet / Oral solution: The recommended posology for adults, adolescents and children from 2 years of age is summarised in Table 2. The dose should be administered in two equally divided doses, approximately 12 hours apart. (See Table 2.)

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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.
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.
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.
Oral solution: It is recommended to parent and caregiver to administer Briviact oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box.
The dose per intake for each patient should be calculated using the following formula: Volume per administration (ml) = [weight (kg) x daily dose (mg/kg/day)] x 0.05.
Briviact oral solution is provided with: a 5 ml syringe (blue graduation marks) graduated every 0.1 ml increments (each 0.1 ml increment corresponds to 1 mg of brivaracetam) (additional graduations at 0.25 ml and 0.75 ml starting at 0.25 ml up to 5 ml are shown); a 10 ml syringe (black graduation marks) graduated in 0.25 ml increments (each 0.25 ml increment corresponds to 2.5 mg of brivaracetam).
The physician should instruct the patient on the appropriate syringe to use.
If the calculated dose per intake is 5 mg (0.5 ml) or more and up to 50 mg (5 ml), the 5 ml oral syringe should be used.
If the calculated dose per intake is more than 50 mg (5 ml), the larger 10 ml oral syringe should be used.
The calculated dose should be rounded to the nearest graduated increment. If the calculated dose is equidistant between two graduated increments, the larger graduated increment should be used.
Tables 3, 4 and 5 provide examples of volumes of oral solution per intake depending on prescribed dose and body weight. The precise volume of oral solution is to be calculated according to the exact body weight of the child. (See Tables 3, 4 and 5.)
Note that the dosage is limited to the available graduations of the syringes. For example, for a patient that needs a dose of 2.15 ml, the applied volume needs to be rounded up to 2.2 ml as the 5 ml syringe can only deliver 2.1 ml or 2.2 ml. Likewise a volume of 1.13 ml would need to be rounded down to a delivered volume of 1.1 ml.

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Click on icon to see table/diagram/image

Solution for injection/infusion: 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.
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.
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.
Film-coated tablet / Oral solution: 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.
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.
Hepatic 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 Precautions, and Pharmacology: Pharmacokinetics under Actions). No clinical data are available in paediatric patients with hepatic impairment. (See Table 6.)

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Paediatric patients less than 2 years of age: The efficacy of brivaracetam in paediatric patients aged less than 2 years has 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.
Solution for injection/infusion: 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 and swallowed in whole with liquid and may be taken with or without food (see Pharmacology: Pharmacokinetics under Actions). Patients not being able to swallow tablets in whole or patients for whom the dose cannot be met with the use of whole tablets should use Briviact 10 mg/ml oral solution.
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.
Briviact oral solution is provided with a 5 ml and a 10 ml oral dosing syringe with their adaptor.
Instructions for use are provided at the back of the package leaflet.
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.