VIMPAT is indicated for:
- Treatment of partial-onset seizures in patients 1 month of age and older
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.
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.
TREATMENT-EMERGENT ADVERSE EVENTS
VIMPAT ADVERSE EVENTS ACROSS ADULT AND PEDIATRIC PARTIAL-ONSET SEIZURE TRIALS WERE CONSISTENT.10
Safety of VIMPAT was evaluated in clinical studies of pediatric patients 1 month to less than 17 years of age for the treatment of partial-onset seizures, and was similar to the safety profile in adult patients with partial-onset seizures.2,10
In 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%).2
The safety profile of VIMPAT as adjunctive therapy in pediatric patients was further confirmed in a placebo-controlled trial.10
Trial enrolled 343 pediatric patients ≥4 to <17 years of age with partial-onset seizures taking 1 to ≤3 concomitant AEDs.
In the pediatric placebo-controlled study, decreased appetite was observed at 3.5% for VIMPAT patients vs 0.6% for placebo; lethargy was observed at 0.6% for VIMPAT patients vs 0.6% placebo; and abnormal behavior was observed at 0.0% in the VIMPAT group vs 0.6% placebo.1
Discontinuation rates due to adverse events
- Discontinuation rates were 5.8% for placebo and 4.1% for the VIMPAT group10
- Reasons for discontinuation in the VIMPAT arm ≥1% were vertigo and diplopia, and all discontinuing patients were on concomitant sodium-channel-blocking AEDs10
VIMPAT INJECTION IN PEDIATRIC PATIENTS (1 MONTH TO LESS THAN 17 YEARS OF AGE)
The safety of VIMPAT injection was evaluated in a multicenter, open-label study of 103 pediatric patients 1 month to less than 17 years of age with epilepsy. Infusions were primarily administered over a 30 to 60 minute time period; infusion times less than 30 minutes were not adequately studied in pediatric patients. Although no serious or severe adverse reactions were noted at the time of infusion in this small study, the adverse reactions associated with VIMPAT injection in pediatric patients are expected to be similar to those noted in adults.
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.
VIMPAT is a Schedule V controlled substance.
Please refer to the full Prescribing Information.
For more information on VIMPAT® contact 844-599-CARE (2273).
IN VIMPAT STUDIES, NO CLINICALLY RELEVANT
INTERACTIONS WERE OBSERVED.2
- No evidence of any clinically relevant drug–drug interactions with AEDs most commonly used
- No clinically relevant non-AED interactions with:
- Digoxin, metformin, omeprazole, midazolam, oral contraceptives containing 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel, or warfarin. This does not rule out the possibility of pharmacodynamic interactions
- 2.VIMPAT® (lacosamide): US prescribing information. Smyrna (GA): UCB, Inc.
- 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.