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One Day Starts With Day One

BRIVIACT® (brivaracetam) CV offers a therapeutic dose from the start for adjunctive treatment of partial-onset (focal) seizures. By taking out the “wait-and-see” with BRIVIACT, the one day your patients most look forward to may be closer than they think.

Melanie:
BRIVIACT® patient

Indication

BRIVIACT® (brivaracetam) CV is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.

IMPORTANT SAFETY INFORMATION

BRIVIACT is associated with important warnings and precautions including suicidal behavior and ideation, somnolence, fatigue, dizziness, disturbance in gait and coordination, psychiatric adverse reactions including non-psychotic and psychotic symptoms, and hypersensitivity reactions (bronchospasm and angioedema).
 BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the 
inactive ingredients.

The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.

BRIVIACT is a Schedule V controlled substance.

Click here to view additional Important Safety Information

About BRIVIACT

BRIVIACT® is a new molecular entity in the racetam class that targets SV2A

  • BRIVIACT is the result of a large rational discovery effort embarked upon by UCB in an effort to find another synaptic vesicle protein (SV2A) ligand as a new addition to the racetam class
  • BRIVIACT displays a high and selective affinity for SV2A in the brain, which may contribute to the anticonvulsant effect1
  • The precise mechanism by which BRIVIACT exerts its anticonvulsant activity is unknown1
IMPORTANT SAFETY INFORMATION

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.

Efficacy

BRIVIACT® significantly reduced the frequency of partial-onset seizures over placebo1

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BRIVIACT® (brivaracetam) CV significantly reduced frequency of partial-onset seizures over placebo
BRIVIACT® (brivaracetam) CV significantly reduced frequency of partial-onset seizures over placeboBRIVIACT® (brivaracetam) CV significantly reduced frequency of partial-onset seizures over placebo
BRIVIACT® (brivaracetam) CV significantly reduced frequency of partial-onset seizures over placeboBRIVIACT® (brivaracetam) CV significantly reduced frequency of partial-onset seizures over placebo

*Statistically significant based on testing procedure with alpha = 0.05.

Studies 1 and 2

  • The primary efficacy analysis for Studies 1 and 2 was based on partial-onset seizure frequency during the treatment period adjusted over 7 days
  • A sequential testing procedure, which required statistical significance at the 0.05 level in both studies, was used to evaluate BRIVIACT doses
  • In Study 1, statistically significant treatment effect was not observed for the 50 mg/day dose; the 100 mg/day dose was nominally significant
  • In Study 2, the 50 mg/day dose showed a statistically significant treatment effect

Study 3

  • The primary efficacy analysis for Study 3 was based on partial-onset seizure frequency during the treatment period adjusted over 28 days
  • The 100 mg/day and 200 mg/day doses showed a statistically significant treatment effect

The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.

The 50% responder rate for BRIVIACT® further demonstrated efficacy across all doses2

Pooled Results from Studies 1, 2, and 3
The 50% responder rate for BRIVIACT® (brivaracetam) CV demonstrated efficacy across all doses

*Statistically significant based on testing procedure with alpha = 0.05.

  • The ≥50% responder rate was calculated based on percent reduction in partial-onset seizure frequency per 28 days from baseline
  • A statistically significant treatment effect was observed with all 3 doses in this pooled analysis
IMPORTANT SAFETY INFORMATION

Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of patients taking at least 50 mg per day of BRIVIACT compared to 14% of patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of patients taking at least 50 mg per day of BRIVIACT compared to 10% of 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.

TRIAL DESIGN

The 1550 patients in BRIVIACT® phase III trials represented one of the largest AED development programs in history

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TRIAL DESIGN: 3 FIXED-DOSE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDIES1

  • There was no titration period in these studies
  • Upon conclusion of each trial, patients were allowed to continue BRIVIACT into an open-label period or down titrate
BRIVIACT® (brivaracetam) CV Trial design for 3 Phase III trialsBRIVIACT® (brivaracetam) CV Trial design for 3 Phase III trials

87% of patients continued into open-label extension trials2

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.

POOLED BASELINE DEMOGRAPHICS AND CHARACTERISTICS ACROSS 3 PIVOTAL TRIALS

BRIVIACT® was studied in a challenging patient population

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Trials evaluated the efficacy and safety of BRIVIACT as adjunctive therapy in patients with partial-onset seizures that were not adequately controlled by 1 to 2 concomitant AEDs1

  • Mean duration of epilepsy: approximately 23 years1
  • Median seizure frequency: 9 seizures per 28 days at baseline1
  • Age (range): 16 to 80 years2
  • AEDs discontinued prior to trial enrollment: 0 to 1 AEDs, 25%; 2 to 4 AEDs, 39%; 5 or more AEDs, 36%2
  • 72% to 86% of patients were on 2 or more concomitant AEDs with or without vagal nerve stimulation (VNS)*†1
  • History of patients who had or have simple partial seizures, 37%; complex partial seizures, 82%; partial seizures with secondary generalization, 31%2

*Benzodiazepines taken more than once a week (for any indication) were considered concomitant AEDs.
VNS was not counted as a concomitant AED in Studies 1 and 2, but was counted in Study 3.

BRIVIACT® was studied with a broad range of AEDs

  • BRIVIACT was added to 1 to 2 concomitant AEDs in placebo-controlled adjunctive therapy pivotal trials*2:

    • Carbamazepine
    • Lacosamide
    • Lamotrigine
    • Levetiracetam†‡
    • Oxcarbazepine
    • Phenobarbital
    • Phenytoin
    • Pregabalin
    • Topiramate
    • Valproic acid
    • Zonisamide

    *AEDs listed were used in ≥5% of the population.
    Patients on levetiracetam were excluded from Study 3.
    Lacosamide and levetiracetam are products manufactured by UCB.

All 3 trials included patients with levetiracetam experience

  • In Studies 1 and 2, which evaluated BRIVIACT dosages of 50 mg and 100 mg daily, approximately 20% of the patients were on concomitant levetiracetam1

    Although the numbers of patients were limited, BRIVIACT provided no added benefit when it was added to levetiracetam1

  • In Study 3, which evaluated 100 mg and 200 mg daily, approximately 54% of patients in this study had prior exposure to levetiracetam1

    • Patients taking concomitant levetiracetam were excluded from the study1
    • In a pre-specified analysis of patients with prior levetiracetam exposure, efficacy over placebo was observed among patients taking BRIVIACT2
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.

Pivotal Trials

Download Pivotal Trial Publications

Study 1

Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: 

A phase III randomized, double-blind, placebo-controlled trial - Victor Biton et al. Epilepsia, 55(1):57–66, 2014

Study 2

Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: 

Results from a double-blind, randomized, placebo-controlled trial - Phillippe Ryvlin et al. Epilepsia, 55(1):47–56, 2014

Study 3

A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures - Pavel Klein et al. Epilepsia, 56(12):1890–1898, 2015

Safety

BRIVIACT® Warnings and Precautions

Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation

  • Monitor patients 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 changes and report them immediately to a healthcare provider

Causes somnolence, fatigue, dizziness, and disturbance in gait and coordination

  • Somnolence and fatigue-related adverse reactions reported in 25% of patients taking at least 50 mg per day of BRIVIACT compared to 14% of patients taking placebo
  • Dizziness and disturbance in gait and coordination reported in 16% of patients taking at least 50 mg per day of BRIVIACT compared to 10% of patients taking placebo
  • Risk is greatest early in treatment but can occur at any time
  • Monitor patients and advise them not to drive or operate machinery until they have sufficient experience on BRIVIACT

Causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms

  • Events reported in approximately 13% of patients taking at least 50 mg per day of BRIVIACT compared to 8% of patients taking placebo
  • 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

Can cause hypersensitivity reactions; bronchospasm and angioedema have been reported

  • Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment
  • Contraindicated in patients with prior hypersensitivity to brivaracetam or any of the inactive ingredients in BRIVIACT

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

Safety and tolerability of BRIVIACT® were evaluated without utilizing a titration period

The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are:

  • somnolence and sedation
  • dizziness
  • fatigue
  • nausea and vomiting symptoms1

ADVERSE REACTIONS THAT OCCURRED AT LEAST 2% MORE FREQUENTLY FOR BRIVIACT DOSES OF AT LEAST 50 MG/DAY THAN PLACEBO IN POOLED PLACEBO-CONTROLLED ADJUNCTIVE THERAPY STUDIES

Adverse reactions in pooled studies (BRIVIACT® [brivaracetam] CV 50 mg, 100 mg, and 200 mg/day
Adverse reactions in pooled studies (BRIVIACT® [brivaracetam] CV 50 mg, 100 mg, and 200 mg/day

*Cerebellar coordination and balance disturbances include ataxia, balance disorder, coordination abnormal, and nystagmus.

There was no apparent dose-dependent increase in adverse reactions with the exception of somnolence and sedation.1

Most adverse events in trials were reported to be mild to moderate.2

Across all 3 trials, discontinuation rates due to adverse events were1:

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

The most common adverse reaction leading to discontinuation was dizziness.2

Drug Interactions

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  • General drug interactions1

    • Rifampin: Co-administration with rifampin decreases BRIVIACT® plasma concentrations likely because of CYP2C19 induction. Increase the BRIVIACT dosage in patients on concomitant rifampin by up to 100% (i.e., double the dosage)
    • Oral contraceptives:
      • BRIVIACT was studied with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg)
      • BRIVIACT 50 mg twice daily (100 mg/day) did not significantly influence the pharmacokinetics of either substance of the oral contraceptive
      • BRIVIACT 200 mg twice daily (400 mg/day, twice the recommended maximum daily dosage) reduced estrogen and progestin AUCs by 27% and 23%, respectively, but did not affect suppression of ovulation
      • The interaction is not expected to be of clinical significance

    BRIVIACT and other AEDs1

    None of the interactions listed below requires changes in the dose of BRIVIACT, but interactions with carbamazepine and phenytoin can be clinically important

    • Carbamazepine: Co-administration may increase exposure to carbamazepine-epoxide (the active metabolite of carbamazepine). Available data did not reveal any safety concerns, but dose reduction should be considered if tolerability issues arise
    • Phenytoin: BRIVIACT can increase plasma concentrations of phenytoin, so levels should be monitored during co-administration
      • At a supratherapeutic dose of 400 mg/day brivaracetam, there was a 20% increase in phenytoin plasma concentration
    • Levetiracetam: BRIVIACT provided no added therapeutic benefit to levetiracetam when the two drugs were co-administered

Dosing

BRIVIACT® offers a therapeutic dose on DAY ONE

The recommended starting dose of 100 mg/day can be initiated without titration1

BRIVIACT® (brivaracetam) CV Dosing Chart: A therapeutic dose on DAY ONE

Gradual dose escalation is not required with BRIVIACT

  • Based on individual patient response, the dose may be adjusted between 25 mg twice daily (50 mg/day) and 100 mg twice daily (200 mg/day)
  • Avoid abrupt withdrawal from BRIVIACT in order to minimize the risk of increased seizure frequency and status epilepticus

Dosing in specific populations

  • For all stages of hepatic impairment, the recommended starting dosage is 25 mg twice daily (50 mg/day) and the recommended maximum dosage is 75 mg twice daily (150 mg/day)
  • Dose adjustments are not required for patients with impaired renal function; there are no data in patients with end-stage renal disease undergoing dialysis, and use of BRIVIACT is not recommended in this patient population

BRIVIACT® is available in multiple formulations, allowing for dosing flexibility

Considerations for tablets and oral solution1

  • BRIVIACT can be given with or without food
  • Tablets should be swallowed whole with liquid; they should not be chewed or crushed; tablets are not scored

Considerations for intravenous (IV) use*1

BRIVIACT injection may be used when oral administration is temporarily not feasible.

Preparation

  • BRIVIACT injection can be administered intravenously without further dilution or may be mixed with diluents listed below:
    • 0.9% sodium chloride injection, USP
    • Lactated Ringer's injection
    • 5% dextrose injection, USP

Administration

  • BRIVIACT injection should be administered intravenously over 2 to 15 minutes

Adverse reactions with BRIVIACT injection are generally similar to those observed with BRIVIACT tablets and also include dysgeusia, euphoric mood, feeling drunk, and infusion site pain.

*Clinical study experience limited to 4 consecutive days of treatment.

BRIVIACT® (brivaracetam) CV is available in multiple formulations, allowing for dosing flexibility

10-mg tablets are available for down titration.


Blood levels1

  • No blood-level monitoring required

Pharmacokinetic profile1

  • Approximately 100% oral bioavailability
  • Linear pharmacokinetics
  • The half-life (t1/2) is approximately 9 hours, steady-state reached after 2 days
  • BRIVIACT is weakly bound (≤20%) to plasma proteins
  • No pharmacologically active metabolites

Co-pay/Savings

Your patients can pay as little as
$20 for a 30-day supply of BRIVIACT

A patient savings card is available for BRIVIACT® (brivaracetam) CV

Have them present the BRIVIACT Patient Savings Card to the pharmacy when filling their prescription

To learn more about card set up, claim transmission, patient eligibility, and more, call OPUS Health for the BRIVIACT Patient Savings Program at 1-888-786-5879 (8:30 am – 5:30 pm ET, Monday – Friday and 8:30 am – 2 pm ET, Saturday).

TERMS AND CONDITIONS

Eligibility Criteria & Terms: The savings card is not valid for use by patients who are covered by any federal or state funded healthcare program (including, but not limited to, Medicare (Part D and Medigap), Medicaid, any state pharmaceutical assistance program, TRICARE, VA, or DoD). Offer good only in the U.S., including Puerto Rico. This card is good for use only with a valid BRIVIACT prescription at the time the prescription is filled by the pharmacist and dispensed to the patient. The maximum annual benefit amount is $1,300 per calendar year. Void where prohibited by law, taxed, or restricted. This offer cannot be combined with any other promotional offer. UCB, Inc. reserves the right to rescind, revoke, or amend this offer without notice at any time. No cash value. Not eligible for sale, purchase, trade, or counterfeit. The card is good for 12 uses.

TO PATIENT: You must present the card to the pharmacist along with your valid BRIVIACT prescription to participate in the BRIVIACT Patient Savings Program. When you use the card, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state or other governmental programs for the prescription. If you have any questions regarding the BRIVIACT Patient Savings Program or wish to discontinue your participation, please call 1-888-786-5879 (8:30 am – 5:30 pm ET, Monday – Friday and 8:30 am – 2 pm ET, Saturday).

TO PHARMACIST: Your acceptance of the card and your submission of claims for the BRIVIACT Patient Savings Program are subject to the Terms and Conditions established by OPUS Health.

For patients with insurance: Submit the claim to the Primary Third Party Payer first, then submit the balance due to OPUS Health as a Secondary Payer as a co-pay only billing using Other Coverage Code indication. You will receive the remaining balance, plus a handling fee, in your next reimbursement from OPUS Health.

For patients without insurance (cash pay): Please submit this claim to OPUS Health, a division of IMS Incorporated. A valid Other Coverage Code is required. Eligible patients can expect to save up to $100 per 30-day supply and you will receive this amount in your reimbursement from OPUS Health, plus a handling fee.

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 patients taking at least 50 mg per day of BRIVIACT compared to 14% of patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of patients taking at least 50 mg per day of BRIVIACT compared to 10% of 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 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.
  • 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

The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.

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., March 2016.
  2. Data on file. UCB, Inc.