Adjunctive therapy in adult patients

VIMPAT DEMONSTRATED SIGNIFICANT CONTROL OF PARTIAL-ONSET SEIZURES
WITH OR WITHOUT SECONDARY GENERALIZATION.3-5*

≥50% responder rates from baseline with VIMPAT vs placebo3-5*
VIMPAT® (lacosamide) CV ≥50% Responder Rates From Baseline
VIMPAT® (lacosamide) CV ≥50% Responder Rates From BaselineVIMPAT® (lacosamide) CV ≥50% Responder Rates From BaselineVIMPAT® (lacosamide) CV ≥50% Responder Rates From Baseline

Significantly more adult patients taking VIMPAT experienced a 50% or greater reduction in seizures from baseline compared with placebo.3-5

Trial design

The efficacy of VIMPAT as adjunctive therapy in partial-onset seizures was established in three 12-week, randomized, multicenter, placebo-controlled, double-blind clinical trials.3-5

Pooled analysis of the results included 1294 adult patients with partial-onset seizures who were not adequately controlled with 1 to 3 concomitant antiepileptic drugs (AEDs), with or without additional vagus nerve stimulation (VNS).6

SELECT IMPORTANT SAFETY INFORMATION

Adverse Reactions

Adjunctive therapy: In adult adjunctive placebo-controlled trials, 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 PLACEBO-CONTROLLED ADJUNCTIVE THERAPY CLINICAL TRIALS,
VIMPAT DEMONSTRATED EFFICACY WHEN ADDED TO A BROAD RANGE OF AEDs.6

Pooled baseline demographics and characteristics across 3 pivotal adult adjunctive therapy trials (N=1294)

  • Age (mean): 38.6 years
  • Female 51.1%, male 48.9%
  • Patients averaged 23 years since diagnosis of epilepsy
  • 45% of patients had tried 7 or more AEDs in his or her lifetime
  • 84% of patients were on 2 or 3 concomitant AEDs when VIMPAT or placebo was added
  • Average seizure frequency was 11.5 seizures every 28 days
  • History of, or presently having: simple partial seizures, 32% (n=416); complex partial seizures, 84% (n=1087); partial seizures with secondary generalization, 42% (n=540)1‡

Some patients experienced more than 1 seizure type at baseline and, therefore, were represented in more than 1 group.

 

VIMPAT was added to 1 to 3 concomitant AEDs in placebo-controlled adjunctive therapy pivotal trials in adult patients.6

  • Carbamazepine
  • Lamotrigine
  • Levetiracetam§
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Topiramate
  • Valproate
  • Zonisamide

§Levetiracetam is a product manufactured by UCB.

Download Complementary Adjunctive Therapy Adult Pivotal Trial Publications

Study 2

Ben-Menachem E, Biton V, Jatuzis D, Abou-Khalil B, Doty P, Rudd GD. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures.
Epilepsia. 2007;48(7):1308-1317.

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Study 3

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.

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Study 4

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.

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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 clinical trials, 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. Dizziness and ataxia were also observed in pediatric clinical trials.

  • Cardiac Rhythm and Conduction Abnormalities:

    PR interval prolongation

    Dose-dependent prolongations in PR interval with VIMPAT have been observed in clinical studies in adult patients and in healthy volunteers. Second-degree and complete AV block have been reported in patients with seizures. When VIMPAT is given with other drugs that prolong the PR interval, further PR prolongation is possible.

    Use VIMPAT with caution in patients with known cardiac conduction problems (e.g., marked first-degree AV block, second-degree or higher AV block and sick sinus syndrome without pacemaker), sodium channelopathies (e.g., Brugada Syndrome), or with severe cardiac disease such as myocardial ischemia or heart failure, or structural heart disease. Also, use VIMPAT with caution in patients on concomitant medications that prolong PR interval (e.g., beta-blockers and calcium channel blockers) because of a risk of AV block or bradycardia. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady-state maintenance dose, is recommended. In addition, closely monitor these patients if they are administered VIMPAT through the intravenous route.

    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. 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

  • Adjunctive therapy: In the adult placebo-controlled clinical trials, 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.

  • Monotherapy: In the adult clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (occurred at a higher rate of ≥2%).

  • 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, 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.

Dosing Considerations

VIMPAT injection is for intravenous and adult 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 safety of VIMPAT injection and the use of a loading dose in pediatric patients have 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 844-599-CARE (2273).