BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).

Approved For Pediatric Patients (4 Years of Age and Older)

BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).

Approved For Pediatric Patients (4 Years of Age and Older)

Efficacy

Efficacy

Efficacy was established in trials that did not utilize a titration period

See more

PERCENT REDUCTION OVER PLACEBO IN PARTIAL-ONSET SEIZURE FREQUENCY ADJUSTED TO 28 DAYS DURING THE TREATMENT PERIOD1

BRIVIACT® (brivaracetam) CV Percent Reduction Over Placebo in Study 3 Chart

Statistically significant based on testing procedure with alpha = 0.05.

  • Effectiveness was established in 3 fixed-dose, randomized, double-blind, placebo-controlled, multicenter
    studies, which included 1550 patients
  • Enrolled patients had partial-onset seizures that were not adequately controlled by 1 to 2 concomitant antiepileptic
    drugs (AEDs)

BRIVIACT® was studied in a challenging patient population

BRIVIACT® (brivaracetam) CV Baseline Characteristics of Patients in Study 3 Table
BRIVIACT® (brivaracetam) CV Baseline Characteristics of Patients in Study 3 Table

IMPORTANT SAFETY INFORMATION

Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of patients taking at least 50 mg per day of BRIVIACT compared to 8% of 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. Advise patients to report these symptoms immediately to a healthcare provider.

Efficacy was observed among patients taking BRIVIACT® who had previously discontinued levetiracetam

See more

PERCENT REDUCTION OVER PLACEBO IN PARTIAL-ONSET SEIZURE FREQUENCY ADJUSTED TO 28 DAYS DURING THE TREATMENT PERIOD3

BRIVIACT® (brivaracetam) CV Patients with Prior Levetiracetam Exposure Chart
BRIVIACT® (brivaracetam) CV Patients with Prior Levetiracetam Exposure Chart

Statistically significant based on testing procedure with alpha = 0.05.

Patients had to discontinue levetiracetam use more than 90 days prior to screening.

  • In Study 3, approximately 54% of patients had prior exposure to levetiracetam and were evaluated in a pre-specified analysis†1,3
    • Of prior levetiracetam patients, approximately 68% had failed levetiracetam due to efficacy, 14% had discontinued for an adverse drug reaction, and 20% had discontinued for other reasons3
  • Patients taking concomitant levetiracetam were excluded from the study1

Patients with prior levetiracetam exposure presented with more severe baseline characteristics

BRIVIACT® (brivaracetam) CV Baseline Characteristics of Patients with Prior Levetiracetam Exposure Table
BRIVIACT® (brivaracetam) CV Baseline Characteristics of Patients with Prior Levetiracetam Exposure Table

IMPORTANT SAFETY INFORMATION

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.

Efficacy

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 4 years to less than 16 years of age were generally similar to those in adult patients.

BRIVIACT is a Schedule V controlled substance.

Please see full Prescribing Information.

To report suspected adverse reactions, contact UCB, Inc. at UCBCares® (1-844-599-2273) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. BRIVIACT (brivaracetam): US prescribing information. Smyrna (GA): UCB, Inc., May 2018.
  2. Gillard M, Fuks B, Leclercq K, Matagne A. Binding characteristics of brivaracetam, a selective, high affinity SV2A ligand in rat, mouse and human brain: relationship to anti-convulsant properties. Eur J Pharmacol. 2011;664(1-3):36–44.
  3. Data on file. UCB, Inc.
  4. Matagne A, Margineanu DG, Kenda B, Michel P, Klitgaard H. Anti-convulsive and anti-epileptic properties of brivaracetam (ucb 34714), a high-affinity ligand for synaptic vesicle protein, SV2A. Br J Pharmacol. 2008;154(8):1662-1671.
  5. Klitgaard H, Matagne A, Nicolas JM, et al. Brivaracetam: Rationale for discovery and preclinical profile of selective SV2A ligand for epilepsy treatment. Epilepsia. 2016;57(4):538-548.
  6. Noyer M, Gillard M, Matagne A, Hénichart J-P, Wülfert E. The novel antiepileptic drug levetiracetam (ucb L059) appears to act via a specific binding site in CNS membranes. Eur J Pharmacol. 1995;286;137-146.
  7. Yan HD, Ishihara K, Seki T, et al. Inhibitory effects of levetiracetam on the high-voltage-activated L-type Ca2+ channels in hippocampal CA3 neurons of spontaneously epileptic rat (SER). Brain Res Bull. 2013;90:142-148.
  8. Niespodziany I, Klitgaard H, Margineanu DG. Levetiracetam inhibits the high-voltage-activated Ca(2+) current in pyramidal neurons of rat hippocampal slices. Neurosci Lett. 2001;306(1-2):5-8.
  9. Lukyanetz EA, Shkryl VM, Kostyuk PG. Selective blockade of N-type calcium channels by levetiracetam. Epilepsia. 2002;43(1):9-18.
  10. Carunchio I, Pieri M, Ciotti MT, Albo F, Zona C. Modulation of AMPA receptors in cultured cortical neurons induced by the antiepileptic drug levetiracetam. Epilepsia. 2007;48(4):654-662.
  11. Rigo JM, Nguyen L, Hans G, et al. UCB 34714: effect on inhibitory and excitatory neurotransmission. Epilepsia. 2004;45(3):56.
  12. PARx Solutions, Inc., November 2017.
  13. CoverMyMeds, LLC, December 2017.
  14. CoverMyMeds. CoverMyMeds website: https://www.covermymeds.com/main/. Accessed October 9, 2017.