BEHAVIORAL &
COGNITIVE
Stability in
Pediatric
Patients

Not an actual patient.

Behavioral and cognitive stability with BRIVIACT:
Pediatric measures were generally unchanged from baseline1

Based on 2 established neurological measurement tools

Parents or caregivers completed the BRIEF® and Achenbach Child Behavior Checklist (CBCL) surveys at regular intervals during the long-term, Phase 3a, follow-up study. The version appropriate for the patient’s age at each visit was completed.1,2

Executive function and self-regulation categories remained stable for the majority of school-aged children (aged 5 to ≤17 years), relative to baseline1

BRIEF® Global Executive Composite score category changes (n=92)1*

Percentage of patients who worsened, improved, or had no change in category graphPercentage of patients who worsened, improved, or had no change in category graph

*

T-score categories were defined as “normal” (0 to <50), “borderline” (50 to <65), and “clinically significant” (≥65).1

 

BRIEF®=Behavior Rating Inventory of Executive Function.1

~9 out of 10 patients aged 5 to ≤17
did not worsen in category from baseline1

Emotional, behavioral, and social problem categories remained stable among the majority of school-aged children (aged 6 to <17 years), relative to baseline1

Shift in CBCL T-score categories (n=127)1†

Shift in CBCL T-score categories graphShift in CBCL T-score categories graph

For all child behavior rating scales, the
majority of patients aged 6 to <17 did not worsen
in categories from baseline1

A similar trend was observed among patients aged 1.5 months
to 5 years who were assessed by a separate CBCL.1

Study Design1,2

Study design for evaluating BRIEF® and Achenbach CBCL

  • Pooled interim analysis from Phase 2a and 3a open-label trials
  • Included pediatric patients 1 month to <17 years (N=219) uncontrolled by 1 to 3 ASMs
  • Of the 219 patients, 168 had focal seizures
  • ASM changes were permitted over the duration of the long-term follow-up study
  • Additional factors may influence measures of behavior and cognition

ASM=antiseizure medication.

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.3

Explore flexible
dosing and
administration
for BRIVIACT3

See Dosing

References: 1. Data on file. UCB, Inc. 2. 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.2019.11.0073. BRIVIACT® (brivaracetam) prescribing information. Smyrna, GA: UCB, Inc.

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.