Brivaracetam is indicated for the treatment of partial-onset seizures in patients aged 1 month and older.

Brivaracetam is an anticonvulsant medication. The exact mechanism by which it produces its anticonvulsant effect is not fully understood. It has a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which is believed to contribute to its seizure-reducing activity.

Brivaracetam tablet or oral solution is taken in oral route. It may be taken with or without food. The recommended dose for patients 1 month of age and older is included below. In pediatric patients weighing less than 50 kg, the recommended dosing regimen is dependent upon body weight. When initiating treatment, gradual dose escalation is not required. Dose should be adjusted based on clinical response and tolerability.

Adults (16 years and older)-

• Initial dose: 50 mg twice daily (100 mg per day)
• Minimum and maximum maintenance dose: 25 mg to 100 mg twice daily (50 mg to 200 mg per day)

Pediatric patients weighing 50 kg or more-

• Initial dose: 25 mg to 50 mg twice daily (50 mg to 100 mg per day)
• Minimum and maximum maintenance dose: 25 mg to 100 mg twice daily (50 mg to 200 mg per day)

Pediatric patients weighing 20 kg to less than 50 kg-

• Initial dose: 0.5 mg/kg to 1 mg/kg twice daily (1 mg/kg to 2 mg/kg per day)
• Minimum and maximum maintenance dose: 0.5 mg/kg to 2 mg/kg twice daily (1 mg/kg to 4 mg/kg per day)

Pediatric patients weighing 11 kg to less than 20 kg-

• Initial dose: 0.5 mg/kg to 1.25 mg/kg twice daily (1 mg/kg to 2.5 mg/kg per day)
• Minimum and maximum maintenance dose: 0.5 mg/kg to 2.5 mg/kg twice daily (1 mg/kg to 5 mg/kg per day)

Pediatric patients weighing less than 11 kg-

• Initial dose: 0.75 mg/kg to 1.5 mg/kg twice daily (1.5 mg/kg to 3 mg/kg per day)
• Minimum and maximum maintenance dose: 0.75 mg/kg to 3 mg/kg twice daily (1.5 mg/kg to 6 mg/kg per day)

Geriatric use: Dose selection for an elderly patient should be judicious, usually starting at the low end of the dosing range.

Renal impairment: Dose adjustments are not required for patients with impaired renal function. Use of brivaracetam is not recommended in patients with end stage renal disease undergoing dialysis.

Use in children and adolescents: Safety and effectiveness in pediatric patients below the age of 1 month have not been established.

Administration

Administration instruction of Brivaracetam injection: Brivaracetam injection may be used for adult patients when oral administration is temporarily not feasible. It can be administered intravenously without further dilution or may be mixed with diluents e.g. 0.9% Sodium Chloride injection/Lactated Ringer’s injection/5% Dextrose injection. It should be administered intravenously over 2 to 15 minutes.

Co-administration with rifampin may reduce plasma levels of brivaracetam, likely due to CYP2C19 enzyme induction. In such cases, the dose of brivaracetam may need to be increased by up to 100% (i.e., doubled). Concurrent use with carbamazepine may increase levels of carbamazepine-epoxide, its active metabolite. If tolerability issues occur, a dose reduction of carbamazepine should be considered. Since brivaracetam can elevate phenytoin plasma concentrations, phenytoin levels should be monitored when brivaracetam is started or discontinued.
No additional therapeutic benefit has been observed when brivaracetam is used together with levetiracetam.

Brivaracetam is contraindicated in patients with known hypersensitivity to brivaracetam or any component of the formulation.

Common adverse effects include nausea, vomiting, constipation, somnolence, sedation, dizziness, fatigue, impaired coordination and balance, and irritability.

Pregnancy: Brivaracetam should be avoided during pregnancy unless clearly necessary, where the potential benefit justifies the possible risk to the fetus.

Lactation: There is no sufficient data regarding the presence of brivaracetam in human milk, its effects on the breastfed infant, or its impact on milk production. The benefits of breastfeeding should be weighed against the mother’s clinical need and any potential risks to the infant.

Antiepileptic drugs (AEDs), including brivaracetam, may increase the risk of suicidal thoughts or behavior. Patients should be closely monitored for signs of depression, mood changes, or unusual behavioral changes. Brivaracetam may cause drowsiness, fatigue, dizziness, and coordination difficulties; therefore, patients should avoid driving or operating machinery if affected. Psychiatric adverse effects may occur, including non-psychotic symptoms (such as irritability, anxiety, aggression, mood swings) and psychotic symptoms (such as hallucinations, paranoia, or acute psychosis). Discontinuation should be gradual to minimize the risk of increased seizure frequency or status epilepticus.

Symptoms of overdose may include vertigo, balance disturbances, fatigue, nausea, double vision, anxiety, and bradycardia. There is no specific antidote available.
Management should be supportive, including maintaining airway, oxygenation, and monitoring vital signs, heart rate, and cardiac rhythm.

Adjunct anti-epileptic drugs

Store in a cool and dry place below 30°C, protected from light. Keep out of reach of children.