Brivaracetam tablets for partial-onset seizure treatment in patients 1 month and older

Brivaracetam tablets are an anticonvulsant medication prescribed for the treatment of partial-onset seizures in patients aged 1 month and older. Available in multiple strengths, these tablets are taken orally and may be used alone or as an add-on therapy to control seizures.

Brivaracetam tablets are approved for managing partial-onset seizures in both adult and pediatric patients starting from 1 month of age.

Brivaracetam

Brivaracetam works by targeting specific sites in the brain involved in seizure activity. It binds selectively to synaptic vesicle protein 2A (SV2A), which is thought to modulate neurotransmitter release and help reduce the frequency of partial-onset seizures.

General dosing for patients 1 month and older

• Adults (16 years and older): Start at 50 mg twice daily (100 mg per day). Dose adjustments can be made between 25 mg and 100 mg twice daily (50 mg to 200 mg per day) based on response and tolerability.
• Pediatric patients: Dosing depends on body weight and is administered twice daily:
  • Weighing 50 kg or more: 25 mg to 50 mg twice daily (50 mg to 100 mg daily), with possible increase to 100 mg twice daily (200 mg daily).
  • 20 kg to less than 50 kg: 0.5 mg/kg to 1 mg/kg twice daily (1 mg/kg to 2 mg/kg daily), adjustable up to 2 mg/kg twice daily (4 mg/kg daily).
  • 11 kg to less than 20 kg: 0.5 mg/kg to 1.25 mg/kg twice daily (1 mg/kg to 2.5 mg/kg daily), adjustable up to 2.5 mg/kg twice daily (5 mg/kg daily).
  • Less than 11 kg: 0.75 mg/kg to 1.5 mg/kg twice daily (1.5 mg/kg to 3 mg/kg daily), adjustable up to 3 mg/kg twice daily (6 mg/kg daily).

Administration

• Take tablets orally with or without food.
• Swallow tablets whole with liquid; do not chew or crush.

Hepatic impairment

• Dose reduction is recommended for all ages and weight groups; for instance, adults start at 25 mg twice daily (50 mg/day) with a maximum of 75 mg twice daily (150 mg/day).
• Specific weight-based dose modifications are recommended for pediatric patients with liver impairment.

Other considerations

• Avoid abrupt discontinuation to reduce risk of increased seizure frequency or status epilepticus; gradual dose reduction is advised.
• Increase brivaracetam dose by up to 100% (double) in patients taking rifampin concurrently.

Brivaracetam tablets are contraindicated in patients with known hypersensitivity to brivaracetam or any of its inactive ingredients due to risk of serious allergic reactions including bronchospasm and angioedema.

Important safety warnings and monitoring

• Suicidal behavior and ideation: Antiepileptic drugs including brivaracetam may increase risk of suicidal thoughts or actions. Close monitoring for mood changes and suicidal behavior is essential throughout treatment.
• Neurological effects: Somnolence, fatigue, dizziness, and coordination problems may occur, especially early in treatment. Patients should be cautious with driving or operating machinery until they understand how the drug affects them.
• Psychiatric symptoms: Behavioral changes such as irritability, anxiety, depression, aggression, psychotic symptoms, and restlessness have been reported. Monitor patients carefully for psychiatric side effects.
• Hypersensitivity: Cases of bronchospasm and angioedema have occurred. Discontinue therapy immediately if signs of hypersensitivity develop and do not restart.
• Serious skin reactions: Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Stop brivaracetam at the first sign of rash unless not drug-related, and do not resume if serious dermatologic reactions are suspected.
• Withdrawal: Gradual dose reduction is recommended to avoid increased seizure risk; however, rapid withdrawal may be considered in serious adverse events.

Common adverse reactions

• Somnolence and sedation (16%)
• Dizziness (12%)
• Fatigue (9%)
• Nausea and vomiting (5%)
• Constipation (2%)
• Cerebellar coordination and balance disturbances such as ataxia, gait disturbance, and nystagmus (3%)

Serious adverse reactions

• Suicidal thoughts or behavior
• Neurological adverse reactions including somnolence and dizziness
• Psychiatric adverse reactions including psychosis and mood changes
• Hypersensitivity reactions such as bronchospasm and angioedema
• Serious dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis

Concurrent use of rifampin reduces brivaracetam exposure significantly. The dosage of brivaracetam should be increased by up to 100% (i.e., doubled) when co-administered with rifampin to maintain therapeutic levels.