Most common AEs—adult Discontinuation rates Most common AEs—pediatric IV safety & tolerability DDI incidence

Safety Data

Not an actual patient.

Most common AEs—adult

Most adverse events (AEs) were reported to be mild or moderate1

The safety profile of BRIVIACT was established in 12-week, Phase 3, adult, placebo-controlled trials2

Most common adverse reactions that occurred in ≥5% for BRIVIACT
and at least 2% more than placebo2

Most common adverse reactions table
Most common adverse reactions table
  • Behavior-related adverse reactions were not common for BRIVIACT in adult pivotal trials2
  • 1.7% of adult patients treated with BRIVIACT discontinued treatment because of psychiatric
    reactions compared to 1.3% of patients who received placebo2

Discontinuation rates

Across all 3 trials, low discontinuation rates due to adverse events were observed2

Discontinuation rates table
Discontinuation rates table

Most common AEs—pediatric

BRIVIACT was generally well tolerated for infants 1 month of age and older1

The safety profile for pediatric patients was similar to adults2

The most common drug-related TEAEs in pooled pediatric studies (≥5%)1

Most common drug-related TEAEs table
Most common drug-related TEAEs table
Study Design1,3

Pooled safety data from Phase 2a and Phase 3a open-label trials of BRIVIACT in patients aged 1 month to <17 years (N=219), uncontrolled by 1 to 3 ASMs. Of the 219 patients, 168 had focal seizures. After dose adjustment, patients received BRIVIACT 1 to 5 mg/kg/day (maximum 200 mg/day).

ASM=antiseizure medication; TEAE=treatment-emergent adverse event.

IV safety & tolerability

BRIVIACT injection safety and tolerability is consistent with oral formulations2

•

The safety and tolerability of BRIVIACT IV have been evaluated as a 15-minute infusion or a bolus (up to 2-minute) injection in an open-label study in children aged 2 months to <16 years with epilepsy1,2

•

The safety and pharmacokinetics of BRIVIACT were similar in the infusion and bolus injection groups1

•

Adverse reactions with BRIVIACT injection in adult and pediatric patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in adult patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain2

DDI incidence

BRIVIACT has a low incidence of drug interactions with other ASMs2

Incidence of drug interactions with BRIVIACT® table
Incidence of drug interactions with BRIVIACT® table
Incidence of drug interactions with BRIVIACT® table

DDI=drug-drug interaction; IV=intravenous.

Behavioral and cognitive
stability were assessed
using 2 established
neurological
measurement tools

See the Data

References: 1. Data on file. UCB, Inc. 2. BRIVIACT® (brivaracetam) prescribing information. Smyrna, GA: UCB, Inc. 3. Patel AD, Badalamenti V, Gasalla T, Elmoufti S, Elshoff JP. Safety and tolerability of adjunctive brivaracetam in children with focal seizures: interim analysis of pooled data from two open-label trials. Eur J Paediatr Neurol. 2020;25:68-76. doi:10.1016/j.ejpn.2019.11.007

Indication

BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

Important Safety Information

WARNINGS AND PRECAUTIONS

  • Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.
  • Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of adult patients taking at least 50 mg per day of BRIVIACT compared to 14% of adult patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of adult patients taking at least 50 mg per day of BRIVIACT compared to 10% of adult patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.
  • Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of adult patients taking at least 50 mg per day of BRIVIACT compared to 8% of adult patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults. Advise patients to report these symptoms immediately to a healthcare provider.
  • Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.
  • Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

DOSING CONSIDERATIONS

  • Dose adjustments are recommended for patients with all stages of hepatic impairment.
  • When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.

ADVERSE REACTIONS

In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients were generally similar to those in adult patients. Adverse reactions with BRIVIACT injection in adult and pediatric patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in adult patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain.

BRIVIACT is a Schedule V controlled substance.

Please see full Prescribing Information.