Briviact oral solution for treating partial-onset seizures in patients from 1 month old

Briviact is an antiepileptic medicine available as tablets, oral solution, and injection, used to treat partial-onset seizures in patients aged 1 month and older. It can be given alone or added to other epilepsy treatments and works by targeting nerve activity in the brain to help control seizures.

Briviact oral solution is approved for the treatment of partial-onset seizures in patients 1 month of age and older, as either monotherapy or adjunctive therapy. It is suitable for use in both pediatric and adult populations. The injection form is reserved for cases when oral administration is temporarily not possible.

brivaracetam

Briviact contains brivaracetam, which is believed to work by binding selectively to synaptic vesicle protein 2A in the brain. This action modulates neurotransmitter release and helps stabilize electrical activity, thereby reducing seizure occurrence.

Adults (16 years and older)

• Starting dose: 50 mg twice daily (100 mg per day)
• Maintenance dose: adjustable between 25 mg to 100 mg twice daily (50 mg to 200 mg per day) based on tolerability and response

Pediatric patients (1 month to less than 16 years)

• Dose is weight-based, taken orally twice daily
• For those ≥50 kg: 25 mg to 50 mg twice daily (50 mg to 100 mg per day)
• 20 kg to <50 kg: 0.5 mg/kg to 1 mg/kg twice daily (1 mg/kg to 2 mg/kg per day), maintenance up to 2 mg/kg twice daily (4 mg/kg per day)
• 11 kg to <20 kg: 0.5 mg/kg to 1.25 mg/kg twice daily (1 mg/kg to 2.5 mg/kg per day), maintenance up to 2.5 mg/kg twice daily (5 mg/kg per day)
• <11 kg: 0.75 mg/kg to 1.5 mg/kg twice daily (1.5 mg/kg to 3 mg/kg per day), maintenance up to 3 mg/kg twice daily (6 mg/kg per day)

Hepatic impairment dose adjustment

• Adults: start at 25 mg twice daily; max 75 mg twice daily
• Pediatric dosing also reduced proportionally by weight-based ranges (see detailed table in label)

Injection use

• For intravenous use only when oral dosing temporarily not feasible
• Same dosage and frequency as oral forms
• Administer IV over 2 to 15 minutes
• Single dose vial; clinical experience limited to 4 consecutive days

Administration instructions

• Tablets: swallow whole with liquid, do not chew or crush
• Oral solution: use calibrated device, no dilution needed; can be given via feeding tubes; discard unused solution 5 months after opening

Additional guidance

• Gradual dose escalation is not required when initiating treatment
• Avoid abrupt withdrawal to reduce risk of increased seizures or status epilepticus
• In patients receiving rifampin, increase dose up to 100%

Briviact is contraindicated in patients with known hypersensitivity to brivaracetam or any of the inactive ingredients due to risk of serious hypersensitivity reactions including bronchospasm and angioedema.

Suicidal behavior and ideation

Briviact and other antiepileptic drugs increase the risk of suicidal thoughts and behavior. Patients should be monitored closely for new or worsening depression, suicidal ideation, or changes in mood or behavior, especially early after starting treatment.

Neurological adverse effects

Common neurologic side effects include somnolence, fatigue, dizziness, and coordination disturbances. Patients should be cautioned against driving or operating machinery until they understand how Briviact affects them.

Psychiatric adverse reactions

Psychiatric effects, including irritability, anxiety, aggression, depression, and psychotic symptoms, have been reported. Approximately 1.7% of adults discontinued Briviact due to psychiatric reactions.

Hypersensitivity reactions

Serious hypersensitivity including bronchospasm and angioedema have occurred. Discontinue Briviact immediately if such reactions develop. It is contraindicated in patients with prior hypersensitivity to brivaracetam or inactive ingredients.

Serious dermatologic reactions

Cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported, typically appearing within 3 to 45 days after treatment start. Discontinue Briviact at first sign of rash unless clearly unrelated.

Withdrawal

Gradual withdrawal is recommended to minimize risk of seizure exacerbation or status epilepticus. Rapid discontinuation may be considered if serious adverse events occur.

Common side effects

• Somnolence and fatigue (about 25% of patients on ≥50 mg/day)
• Dizziness and balance or coordination problems (16% of patients on ≥50 mg/day)
• Psychiatric symptoms such as irritability, anxiety, aggression, depression (about 13% versus 8% in placebo)

Serious reactions

• Hypersensitivity reactions including bronchospasm, angioedema
• Serious skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis
• Psychotic symptoms (hallucinations, paranoia, acute psychosis)

Concomitant use of rifampin significantly reduces Briviact blood levels; doubling the Briviact dose is recommended in patients receiving rifampin to maintain efficacy.

Discard any unused Briviact oral solution 5 months after first opening.

For injection, diluted solutions should not be stored for more than 4 hours at room temperature and may be stored in PVC bags. Discard any unused portion of the vial.