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START AND STAY WITH BRIVIACT FOR
THEIR LONG-TERM JOURNEY

5-year long-term retention and SGTC seizure freedom data available1,2

BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.3

 

One year after beginning BRIVIACT, an estimated 8 out of 10 patients were still on treatment2

 

KAPLAN-MEIER ESTIMATE OF PERCENTAGE OF ADULT PATIENTS REMAINING ON TREATMENT IN A POOLED STUDY2

Percentage of Adult Patients remaining on Treatment, Graph

Adapted from Toledo et al, 2016.

Five years post initiation, more than half of patients were still taking BRIVIACT, as estimated in the study2

  • Patients who discontinued for reasons other than lack of efficacy or adverse events were censored from the analysis2
  • This retention data is an estimation of how long patients remained on BRIVIACT in select studies. Conclusions of long-term efficacy or safety should not be drawn based on this data2
  • Limited exposure was seen at the later time points; 41 patients (1.7%) continued treatment for ≥8 years, and 3 patients (0.1%) continued for ≥8.5 years2

Study design2

  • Adult patients with epilepsy from phase 2b and phase 3 trials, uncontrolled by 1-3 ASMs
  • Patients continued into an open-label, long-term, follow-up trial, taking BRIVIACT 50-200 mg/day (N=2,051)

This long-term retention data is an estimation of how long patients have remained on treatment in select BRIVIACT clinical studies.

ASM=antiseizure medication.

The established efficacy of BRIVIACT provides a strong treatment foundation

PERCENT REDUCTION (BRIVIACT ADJUNCTIVE THERAPY OVER PLACEBO) IN FOCAL SEIZURE FREQUENCY ADJUSTED TO 28 DAYS DURING THE TREATMENT PERIOD3

BRIVIACT® + Current Therapy, Percentage Reduction in Focal Seizure Frequency, Graph

Across all 3 trials, low discontinuation rates due to
adverse events were observed3:

  • Placebo: 4%
  • BRIVIACT 50 mg/day: 5%
  • BRIVIACT 100 mg/day: 8%
  • BRIVIACT 200 mg/day: 7%

Pivotal trial design3

  • Effectiveness was established in 3 fixed-dose, randomized, double-blind, placebo-controlled, multicenter studies with a 12-week treatment period, and comprised 1,550 adult patients
  • Enrolled adult patients had focal seizures that were not adequately controlled by 1 to 2 concomitant ASMs
  • Patients taking concomitant levetiracetam were excluded from Study 3

ASM=antiseizure medication.

Patients with ~3 SGTCS per 28 days at baseline achieved SGTC seizure freedom in the short and long term1,4

SHORT-TERM (12-WEEK) SGTC SEIZURE FREEDOM RATE FROM A POOLED POST HOC ANALYSIS4

Short-Term (12-Week) Sgtc Seizure Freedom Rate From A Pooled Post-Hoc Analysis4, Graph

SGTCS=secondarily generalized tonic-clonic seizure.

LONG-TERM (5 YEARS)
More than 1 in 3 patients overall (35%) experienced zero SGTC seizures for at least one year during the long-term follow-up post hoc analysis1

More patients achieved seizure freedom for a year or more when BRIVIACT was started earlier, according to long-term data5

PATIENTS WITH ≥1 YEAR SGTC SEIZURE FREEDOM AT ANY TIME DURING THE LONG-TERM (5-YEAR) FOLLOW-UP POST HOC ANALYSIS5

Patients With ≥1 Year Sgtc Seizure Freedom At Any Time During The Long-Term (5-Year) Follow-Up Post-Hoc Analysis, Graph
 

Study design

  • 12 weeks: Post hoc analysis of patients with SGTC seizures among their baseline seizures from pooled data of three Phase 3 pivotal trials4
  • 5 years: Post hoc analysis conducted to evaluate the efficacy and tolerability of long-term BRIVIACT treatment in patients ≥16 years of age who reported SGTCS during the 8-week baseline of three Phase 3 pivotal trials and received adjunctive BRIVIACT in either the pivotal trials or the long-term follow up1
  • Efficacy (concomitant levetiracetam excluded) and tolerability (concomitant levetiracetam included) were assessed on the first day of BRIVIACT in patients who initiated BRIVIACT at 50-200 mg/day1

 

BRIVIACT offers simple 1:1 dose conversion between formulations3

Examples of Oral and IV Administrations of BRIVIACT® Examples of Oral and IV Administrations of BRIVIACT®

Products not shown at actual size.

  • Dose adjustments are recommended for patients with all stages of hepatic impairment3
  • When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended3

BRIVIACT exhibits a linear and time-independent pharmacokinetic profile3

 

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UCB provides multiple resources for eligible patients starting on BRIVIACT

Learn more about savings & support

 

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

References

  1. Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: post hoc pooled analysis. Epilepsy Res. 2021;176:1-11.
  2. Toledo M, Whitesides J, Schiemann J, et al. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016;57(7):1139-1151. doi:10.1111/epi.13416
  3. BRIVIACT® (brivaracetam): US prescribing information. Smyrna, GA: UCB, Inc.
  4. Moseley BD, Sperling MR, Asadi-Pooya AA, et al. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016;127:179-185.
  5. Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary-generalized) seizures: post hoc analysis. Epilepsy Res. Journal Pre-proof, 2021.
  6. Stockis A, Hartstra J, Mollet M, Hadi S. Bioavailability and bioequivalence comparison of brivaracetam 10, 50, 75, and 100 mg tablets and 100 mg intravenous bolus. Epilepsia. 2016;57(8):1288-1293.
  7. Nicolas JM, Hannestad J, Holden D, et al. Brivaracetam, a selective high-affinity synaptic vesicle protein 2A (SV2A) ligand with preclinical evidence of high brain permeability and fast onset of action. Epilepsia. 2016;57:201-209.
  8. Klein P, Diaz A, Gasalla T, Whitesides J. A review of the pharmacology and clinical efficacy of brivaracetam. Clin Pharmacol. 2018;10:1-22.