Indicated for:

Partial-Onset Seizures:

• The treatment of partial-onset seizures in patients 1 month of age and older.

Primary Generalized Tonic-Clonic Seizures:

• Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

The use of a loading dose in pediatric patients has not been studied.

The clinical study experience of intravenous VIMPAT is limited to 5 days of consecutive treatment.

For patients who are already on a single AED and will convert to VIMPAT monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of VIMPAT is achieved and has been administered for at least 3 days. A gradual withdrawal of the concomitant AED over at least 6 weeks is recommended.

For patients with severe renal impairment [creatinine clearance (CL_CR) less than 30 mL/min as estimated by the Cockcroft-Gault equation for adults; CL_CR less than 30 mL/min/1.73m² as estimated by the Schwartz equation for pediatric patients] or end-stage renal disease, a reduction of 25% of the maximum dosage is recommended.

For patients with mild or moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. VIMPAT use is not recommended in patients with severe hepatic impairment.

Antiepileptic drugs (AEDs), including VIMPAT, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

VIMPAT may cause dizziness and ataxia.

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.

Intravenous infusion of VIMPAT may cause bradycardia, AV blocks, and ventricular tachyarrhythmia. Obtaining an ECG before beginning VIMPAT and after VIMPAT is titrated to steady-state maintenance dose is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction

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.

Cases of syncope have also been observed in open-label clinical partial-onset seizure studies in adult and pediatric patients.

As with all AEDs, VIMPAT should be withdrawn gradually (over a minimum of 1 week) to minimize the potential of increased seizure frequency in patients with seizure disorders.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, has been reported in patients taking antiepileptic drugs, including VIMPAT.

Phenylalanine can be harmful in patients with phenylketonuria (PKU). VIMPAT oral solution contains aspartame, a source of phenylalanine.

Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients.

VIMPAT should be used with caution in patients on concomitant medications that affect cardiac conduction (sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers) including those that prolong PR interval (including sodium channel blocking AEDs), because of a  risk of AV block, bradycardia, or ventricular tachyarrhythmia. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady-state, is recommended.

There are no adequate data on the developmental risks associated with the use of VIMPAT in pregnant women. Animal studies: developmental toxicity (increased embryo-fetal and perinatal mortality, growth deficit).

There are no data on the presence of lacosamide in human milk, the effects on the breastfed infant, or the effects on milk production. Studies in lactating rats have shown excretion of lacosamide and/or its metabolites in milk.

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• Use in patients under 1 month of age. GoToSource

• Bipolar disorder, mania, depression, cocaine addiction and anxiety. GoToSource

• Amnesic symptoms of alzheimer’s disease. GoToSource

• Diabetic peripheral neuropathy and fibromyalgia. GoToSource

• Lance–adams syndrome and lennox–gastaut syndrome. GoToSource

• Migraine. GoToSource

Psychosis. GoToSource

AV blockage, atrial flutter/fibrillation and sinus node dysfunction, bradycardia (slow heart rate) elevated liver enzymes, hypotension (low blood pressure) and angioedema (swelling in deep layers of skin). GoToSource

Pitch perception deficit. GoToSource

Drug reaction with eosinophilia and systemic symptoms (potentially life-threatening drug reaction). GoToSource

Liver injury. GoToSource

Dizziness, ataxia (lack of coordination), vomiting, diplopia (double vision), nausea, vertigo (sensation of motion), blurred vision and increased risk of suicidal ideation and behavior. GoToSource

Lawsuits filed for suicidality.