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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.

VIEW FULL PRESCRIBING INFORMATION

ADJUNCTIVE THERAPY FOR ADULTS AND CHILDREN (4 YEARS OF AGE AND OLDER) FOR PGTCS

VIMPAT® HAS BEEN STUDIED FOR PGTCS IN A
NOVEL ADJUNCTIVE AED PIVOTAL TRIAL.11

THE EFFICACY AND SAFETY OF VIMPAT WAS EVALUATED IN
ADULTS AND PEDIATRIC PATIENTS AGED ≥4 YEARS11

Patients had idiopathic generalized epilepsy and primary generalized tonic-clonic seizures (PGTCS) not adequately controlled by 1–3 concomitant antiepileptic drugs (AEDs).

  • More than one-third of patients had a history of absence and/or myoclonic seizures

PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED,
PARALLEL-GROUP, MULTICENTER, TIME-TO-EVENT STUDY
Efficacy and Safety for VIMPAT® (lacosamide) CV in PGTCS
Phase 3 Double Blind Study

*The treatment period continued until one of the following occurred: completion of ≥6 weeks of the treatment period and occurence of two or more PGTCS; completion of 24 weeks of the treatment period without occurrence of two PGTCS; or the 125th event occurred in the trial.

Time to second PGTCS as the primary endpoint enabled non-responders to complete the trial early, minimizing their exposure to potentially suboptimal treatment.

  • A time-to-event trial differs from traditional outcomes that assess reduction in seizure frequency and require a high baseline PGTCS frequency

TIME TO EVENT: A NOVEL STUDY DESIGN FOR VIMPAT IN PGTCS

 

IMPORTANT SAFETY INFORMATION

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.

 

PGTCS RISK REDUCTION

VIMPAT® SIGNIFICANTLY REDUCED THE RISK OF
PATIENTS EXPERIENCING A SECOND PGTCS VS PLACEBO
2,11

VIMPAT REDUCED THE RISK OF A SECOND PGTCS BY 45% VS PLACEBO (CURRENT THERAPY)
DURING A 24-WEEK TREATMENT PERIOD2

Patients treated with VIMPAT had a significantly lower risk of developing a second PGTCS vs placebo over 24 weeks (p=0.001).*2

KAPLAN-MEIER ESTIMATES FOR TIME TO SECOND PGTCS11
Graph of Kaplan-Meier Estimates for Time to Second PGTCS
Graph of Kaplan-Meier Estimates for Time to Second PGTCS

 

*Based on Kaplan-Meier survival estimates of patients in the modified full analysis set (FAS).2

Note: The numbers at the bottom of the figure are for patients still at risk in the study at a given timepoint (i.e., the continuing patients in the study without an event or censoring prior to the timepoint).2

In the PGTCS clinical trial, the most common adverse reactions (≥10%) reported in patients treated with VIMPAT were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%).2


VIMPAT IN PGTCS: EFFICACY AND SAFETY

 

IMPORTANT SAFETY INFORMATION

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.

PGTCS FREEDOM

VIMPAT® DEMONSTRATED CLINICAL EFFICACY IN PGTCS,
GIVING MORE PATIENTS PGTC SEIZURE FREEDOM11

SIGNIFICANTLY MORE PATIENTS WERE FREE FROM PGTCS WITH VIMPAT VS PLACEBO
(CURRENT THERAPY) OVER 24 WEEKS (P=0.011)11

STRATIFIED* KAPLAN-MEIER ESTIMATES OF PGTCS FREEDOM RATES % (95% CI)
Stratified Kaplan-Meier Estimates of PGTCS Freedom Rates % (95% Cl) Chart
Stratified Kaplan-Meier Estimates of PGTCS Freedom Rates % (95% Cl) Chart

 

*Participants in the study were stratified based on baseline PGTCS frequency and age (seizure frequency ≤2 per 28 days and either pediatric or adult; seizure frequency >2 per 28 days);
Estimated by extended Mantel–Haenszel methods;
Based on a chi-square test on 1 degree of freedom.

 

IMPORTANT SAFETY INFORMATION

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.

 

SIMILAR IMPROVEMENTS IN 50% AND 75% PGTCS RESPONDER RATES WERE
OBSERVED WITH VIMPAT VS PLACEBO (CURRENT THERAPY)11

RESPONDER RATES FOR PGTCS OVER 24 WEEKS*
Responder Rates for PGTCS Over 24 Weeks Chart
Responder Rates for PGTCS Over 24 Weeks Chart

 

*Percentages for responder status are based on the number of patients in the FAS. A responder is a patient experiencing ≥50% or ≥75% reduction in PGTCS frequency per 28 days from the combined baseline to the period of interest.

 

References

  1. 2.VIMPAT® (lacosamide): US prescribing information. Smyrna (GA): UCB, Inc.
  2. 11.Vossler DG, Knake S, O’Brien TJ, et al. Efficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomised, placebo-controlled trial. J Neurol Neurosurg Psychiatry 2020;91:1067–1075.

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).