Adults Children

FOR PARTIAL-ONSET SEIZURES, USE VIMPAT® AS ADJUNCTIVE THERAPY OR MONOTHERAPY FOR CHILDREN 4 YEARS OF AGE AND OLDER

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The pediatric indication for VIMPAT for the treatment of partial-onset seizures is based on the principle of extrapolation of efficacy data from adults and is supported by safety and pharmacokinetics data collected in children.The efficacy of VIMPAT in pediatric patients 4 years of age and older with partial-onset seizures was confirmed in a placebo-controlled pediatric trial.

Adult Efficacy Data

Pediatric Placebo-Controlled Trial

INDICATION

VIMPAT® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

IMPORTANT SAFETY INFORMATION

VIMPAT is associated with important warnings and precautions including suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity.

Partial-Onset Seizures
In the adult adjunctive placebo-controlled trials for partial-onset seizures, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%). Pediatric adverse reactions were similar to those seen in adult patients.

Primary Generalized Tonic-Clonic Seizures
In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizures trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea.

VIMPAT is a Schedule V controlled substance.

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VIMPAT IS APPROVED FOR PARTIAL-ONSET SEIZURE TREATMENT OF PEDIATRIC PATIENTS AGES 4 YEARS AND OLDER BASED ON EXTRAPOLATION OF DATA FROM ADULT STUDIES, INCLUDING:

  • Three 12-week, randomized, multicenter, placebo-controlled, double-blind clinical adjunctive therapy trials in adult patients at 200 mg/day and 400 mg/day3-5
  • A conversion-to-monotherapy trial in adult patients using a historical control group8


VIMPAT pediatric efficacy also was studied in a placebo-controlled adjunctive trial that demonstrated efficacy in pediatric patients 4 years of age and older with partial-onset seizures with or without secondary generalization.10

Adult efficacy dataPediatric placebo-controlled trial

ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS (4 years of age and older)
WITH PARTIAL-ONSET SEIZURES

VIMPAT ESTABLISHED ADULT EFFICACY FOR PARTIAL-ONSET SEIZURES HAS
BEEN EXTRAPOLATED FOR PEDIATRIC PATIENTS.2

Adult efficacy was demonstrated in patients with partial-onset seizures and has been extrapolated to children ages 4 and older according to FDA guidelines.

ADULT ADJUNCTIVE EFFICACY

VIMPAT demonstrated significant control of partial-onset seizures in adults with or without secondary generalization.

  • The efficacy of VIMPAT as adjunctive therapy was established in three 12-week, randomized, multicenter, placebo-controlled, double-blind clinical trials at 200 mg/day and 400 mg/day


≥50% RESPONDER RATES FROM BASELINE WITH VIMPAT VS PLACEBO IN PIVOTAL ADJUNCTIVE THERAPY ADULT TRIALS3-5*
≥50% Responder Rates From Baseline vs Placebo Chart
≥50% Responder Rates From Baseline vs Placebo Study 2 Chart ≥50% Responder Rates From Baseline vs Placebo Study 3 Chart ≥50% Responder Rates From Baseline vs Placebo Study 4 Chart
  • Significantly more VIMPAT patients demonstrated a 50% or greater reduction in seizures compared with placebo3-5
  • In adult adjunctive placebo-controlled trials for partial-onset seizures (200 mg/day and 400 mg/day), the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia2

Learn more about adult efficacy data

MONOTHERAPY IN PEDIATRIC PATIENTS (4 years of age and older)
FOR PARTIAL-ONSET SEIZURES

FOR MONOTHERAPY, VIMPAT MET THE PREDEFINED CRITERIA
FOR EFFICACY IN ADULTS WITH PARTIAL-ONSET SEIZURES.2,8

VIMPAT USE AS MONOTHERAPY IN ADULTS WITH PARTIAL-ONSET SEIZURES WAS EVALUATED IN A HISTORICAL CONTROL TRIAL

VIMPAT was tested in a conversion-to-monotherapy trial using a historical control group derived from a meta-analysis of data from 8 previous AED monotherapy trials of similar design, which utilized a subtherapeutic dose of an AED as a control.

  • VIMPAT met the pre-specified criteria for efficacy at doses of 400 mg/day or 300 mg/day
  • VIMPAT demonstrated statistical superiority to the historical control
  • In the adult monotherapy clinical trial (300 mg/day and 400 mg/day), adverse reactions were generally similar to those observed and attributed to drug in adult adjunctive placebo-controlled trials for partial-onset seizures, with the exception of insomnia (occurred at a higher rate of ≥2%)

Pediatric Efficacy

VIMPAT PEDIATRIC EFFICACY WAS STUDIED IN A
PLACEBO-CONTROLLED ADJUNCTIVE TRIAL FOR PARTIAL-ONSET SEIZURES.10

Trial evaluated the efficacy and safety of VIMPAT as adjunctive therapy in 343 children with partial-onset seizures not adequately controlled by 1 to 3 concomitant AEDs.

POOLED BASELINE DEMOGRAPHICS AND CHARACTERISTICS
Pooled Baseline Demographics and Characteristics Table
Pooled Baseline Demographics and Characteristics Table

*AEDs taken and stopped >28 days prior to entering baseline period or AEDs with unknown stop date.

VIMPAT PEDIATRIC EFFICACY WAS CONFIRMED IN PATIENTS WITH PARTIAL-ONSET SEIZURES.10

Pediatric adjunctive efficacy

VIMPAT demonstrated efficacy in pediatric patients with partial-onset seizures with or without secondary generalization.

The efficacy and safety of adjunctive VIMPAT therapy in 343 pediatric patients 4 years of age or older with partial-onset seizures not adequately controlled by 1–3 concomitant AEDs was further established in a placebo-controlled, double-blind, multicenter, randomized trial.

≥50% RESPONDER RATES FROM BASELINE TO MAINTENANCE PERIOD WITH VIMPAT VS
PLACEBO IN PEDIATRIC, PLACEBO-CONTROLLED ADJUNCTIVE THERAPY TRIAL
≥50% Response, Baseline to Maintenance vs Placebo Chart

Average median VIMPAT total daily dose during maintenance period1

|  <30 kg: 10.5 mg/kg/day  |  ≥30 to <50 kg: 7.4 mg/kg/day  |  ≥50 kg: 6.2 mg/kg/day  |

  • Significantly more VIMPAT pediatric patients demonstrated a 50% or greater reduction in seizures compared to patients taking placebo
    • FDA approval was based on the adult efficacy data
  • In the pediatric placebo-controlled trial for partial-onset seizures, the most common adverse reactions (≥10%) were dizziness and somnolence

References

  1. 1.Data on file. UCB, Inc.
  2. 2.VIMPAT® (lacosamide): US prescribing information. Smyrna (GA): UCB, Inc.
  3. 3.Ben-Menachem E, Biton V, Jatuzis D, et al. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007;48(7):1308-1317.
  4. 4.Chung S, Sperling MR, Biton V, et al; on behalf of the SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010;51(6):958-967.
  5. 5.Halász P, Kälviäinen R, Mazurkiewicz-Bełdzińska M, et al. Adjunctive lacosamide for partial-onset seizures: efficacy and safety results from a randomized controlled trial. Epilepsia. 2009;50(3):443-453.
  6. 8.French JA, Wang S, Warnock B, et al. Historical control monotherapy design in the treatment of epilepsy. Epilepsia. 2010;51(10):1936-1943.
  7. 10.Farkas W, Steinborn B, Flamini R, et al. Efficacy and tolerability of adjunctive lacosamide in paediatric patients with focal seizures. Neurology. 2019;93;e1212-e1226.

Important Safety Information

Warnings and Precautions

  • Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including VIMPAT, increase the risk of suicidal behavior and ideation. Monitor patients taking VIMPAT for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to the healthcare provider.

  • Dizziness and Ataxia: VIMPAT may cause dizziness and ataxia in adult and pediatric patients. In adult clinical trials for partial-onset seizures, the onset of dizziness and ataxia was most commonly observed during titration. Advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they are familiar with the effects of VIMPAT on their ability to perform such activities.

  • Cardiac Rhythm and Conduction Abnormalities
    PR Interval Prolongation, Atrioventricular Block, and Ventricular Tachyarrhythmia
    Dose-dependent prolongations in PR interval with VIMPAT have been observed in clinical studies in adult patients and in healthy volunteers. When VIMPAT is given with other drugs that prolong the PR interval, further PR prolongation is possible.

    In the postmarketing setting, there have been reports of cardiac arrhythmias in patients treated with VIMPAT, including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death. Most, although not all, cases have occurred in patients with underlying proarrhythmic conditions, or in those taking concomitant medications that affect cardiac conduction or prolong the PR interval. These events have occurred with both oral and intravenous routes of administration and at prescribed doses as well as in the setting of overdose.

    VIMPAT should be used with caution in patients with underlying proarrhythmic conditions such as known cardiac conduction problems (e.g., marked first-degree AV block, second-degree or higher AV block, and sick sinus syndrome without pacemaker), severe cardiac disease (such as myocardial ischemia or heart failure, or structural heart disease), and cardiac sodium channelopathies (e.g., Brugada Syndrome).

    VIMPAT should also be used with caution in patients on concomitant medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady-state maintenance dose, is recommended. In addition, these patients should be closely monitored if they are administered VIMPAT through the intravenous route. Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away.

    Atrial Fibrillation and Atrial Flutter
    VIMPAT administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease.

  • Syncope: VIMPAT may cause syncope in adult and pediatric patients.

  • Withdrawal of Antiepileptic Drugs: Gradually withdraw VIMPAT (over a minimum of 1 week) to minimize the potential of increased seizure frequency.

  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Also known as multi-organ hypersensitivity, has been reported with antiepileptic drugs, including VIMPAT. Some of these events have been fatal or life-threatening. If signs or symptoms are present, immediately evaluate the patient. Discontinue VIMPAT if an alternative etiology for the signs and symptoms cannot be established.

  • Risks in Patients with Phenylketonuria: VIMPAT oral solution contains aspartame, a source of phenylalanine, which can be harmful in patients with phenylketonuria (PKU). A 200 mg dose of VIMPAT oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

Adverse Reactions

  • Partial-Onset Seizures: In the adult adjunctive therapy placebo-controlled clinical trials for partial-onset seizures, the most frequently seen adverse reaction with VIMPAT was dizziness (31% vs 8% placebo). Other common adverse reactions occurring in ≥10 percent of VIMPAT-treated patients, and greater than placebo, were headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%).

  • Primary Generalized Tonic-Clonic Seizures: In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizure placebo-controlled trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea.

  • Pediatric Patients: Adverse reactions reported in clinical studies of pediatric patients 4 to less than 17 years of age were similar to those seen in adult patients.

  • Injection: In adult adjunctive therapy clinical trials for partial-onset seizures, adverse reactions with intravenous administration generally were similar to those that occurred with the oral formulation, although intravenous administration was associated with local adverse reactions such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). When administering a loading dose, the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia, may be higher with 15-minute administration than over a 30- to 60-minute period. The adverse reactions associated with VIMPAT injection in adult patients with primary generalized tonic-clonic seizures are expected to be similar to those seen in adults with partial-onset seizures. The adverse reactions associated with VIMPAT injection in pediatric patients are expected to be similar to those noted in adults. Infusion times less than 30 minutes were not adequately studied in pediatric patients.

Dosing Considerations

VIMPAT injection is for intravenous use only when oral administration is temporarily not feasible. The loading dose for adult patients should be administered with medical supervision considering the VIMPAT pharmacokinetics and increased incidence of CNS adverse reactions. The use of a loading dose in pediatric patients has not been studied. Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in patients with severe hepatic impairment is not recommended. Perform dose titration with caution in all patients with renal and/or hepatic impairment.

VIMPAT is a Schedule V controlled substance.

Please see full Prescribing Information.

For more information on VIMPAT® contact 1-844-599-CARE (2273).

INDICATION

VIMPAT® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of VIMPAT injection in pediatric patients has not been established, VIMPAT injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older).

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SELECT IMPORTANT SAFETY INFORMATION

VIMPAT is associated with important warnings and precautions including suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity.

In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%). In the adult adjunctive placebo-controlled trials, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia. Pediatric adverse reactions were similar to those seen in adult patients.

VIMPAT is a Schedule V controlled substance.

For more information, please see the updated full Prescribing Information and Medication Guide.

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