Start and Stay
with BRIVIACT
for
Pediatric
Patients

No actual patients are depicted.

One year after starting treatment, ~7 in 10 pediatric patients remained on BRIVIACT1

Kaplan-Meier curve of pediatric patients remaining on
treatment in a pooled study1*†

Percentage of patients with focal seizures remaining on treatment over 24 months, Kaplan-Meier Pediatrics estimate graph Percentage of patients with focal seizures remaining on treatment over 24 months, Kaplan-Meier Pediatrics estimate graph

*

Kaplan-Meier estimates of the percentage of subjects completing only the specified duration of treatment with BRIVIACT regardless of any discontinuation reason.1

†

Each circle represents at least one censored event.1

Two years after starting treatment, an estimated
6 in 10 pediatric patients remained on BRIVIACT1

  • This analysis was focused on time to discontinuation among patients with focal seizures (n=168) aged ≥1 month to <17 years, uncontrolled by 1-3 prior ASMs1,2
  • These retention data are based on Kaplan-Meier analyses of how long patients remained on BRIVIACT.
    Conclusions of long-term efficacy or safety should not be drawn based on this data
Study Design1,2
  • Pooled data from Phase 2a and Phase 3a open-label trials of BRIVIACT
  • 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.

BRIVIACT was studied in
a challenging
pediatric
population3

See Pediatric Efficacy Data

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.2019.11.007 3. Liu E, Dilley D, McDonough B, Stockis A, Daniels T. Safety and tolerability of adjunctive brivaracetam in pediatric patients <16 years with epilepsy: an open-label trial. Paediatr Drugs. 2019;21(4):291-301. doi:10.1007/s40272-019-00332-y

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.