INDICATION

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.

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

Recommended Dosage in Pediatric Patients Aged 4 Years to <17 Years Chart
Recommended Dosage in Pediatric Patients Aged 4 Years to <17 Years Chart
Recommended Dosage in Adults (Aged 17 Years and Older) Chart
Recommended Dosage in Adults (Aged 17 Years and Older) Chart
  • Dosage should be increased based on clinical response and tolerability, no more frequently than once per week
  • Gradually withdraw VIMPAT (over a minimum of 1 week) to minimize the potential for increased seizure frequency

200 mg LOADING DOSE FOR ADULT PATIENTS |

Use the VIMPAT loading dose when your adult patients need to get to a therapeutic dose more rapidly than standard titration allows. The use of a loading dose in pediatric patients has not been studied.

A single loading dose of 200 mg approximates steady-state concentrations comparable to the 100 mg twice-daily oral administration.

Loading Dose Chart
Loading Dose Chart

(Formulations not shown at actual size.)

Loading dose administration2

VIMPAT may be initiated in adult patients with a single loading dose of 200 mg (oral or injection) followed approximately 12 hours later by 100 mg twice-daily (200 mg/day).

  • Based on individual response and tolerability, the dose can be increased at weekly intervals by 50 mg twice-daily (100 mg/day), as needed, up to the recommended monotherapy* (300 mg/day to 400 mg/day) or adjunctive therapy (200 mg/day to 400 mg/day) maintenance dose
  • The loading dose should be administered with medical supervision considering the VIMPAT pharmacokinetics and increased incidence of CNS adverse reactions

Adverse reactions

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.

*Monotherapy for partial-onset seizures only.

 

INTRAVENOUS DOSING |

Special considerations when using injection

VIMPAT® (lacosamide) CV IV Vial Image

(Formulation not shown at actual size.)

VIMPAT injection for intravenous use—indicated as
short-term replacement when oral administration is not feasible.

  • VIMPAT injection can be administered intravenously to adult and pediatric patients weighing 6 kg or more with the same dosing regimens described for oral dosing. For pediatric patients weighing less than 6 kg, VIMPAT injection may be initiated with a dose of 0.66 mg/kg three times daily. See table above.
  • The recommended infusion duration is 30 to 60 minutes; however, infusions as rapid as 15 minutes can be administered in adults if required
  • Infusion durations less than 30 minutes are generally not recommended in pediatric patients
  • 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
  • Cmax reached by end of infusion time
  • Adverse reactions with IV administration generally appeared similar to those observed with the oral formulation, although IV administration was associated with local adverse events, such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%)
IV Administration Chart

Intravenous injection solution preparation

  • VIMPAT injection can be administered intravenously without further dilution or may be mixed with diluents listed below. The diluted solution should not be stored for more than 4 hours at room temperature
  • Diluents: Sodium Chloride Injection 0.9% (w/v), Dextrose Injection 5% (w/v), Lactated Ringer’s Injection
  • Product with particulate matter or discoloration should not be used
  • VIMPAT injection is for single-dose only—any unused portion of VIMPAT injection should be discarded

 

ORAL SOLUTION DOSING |

Special considerations when using oral solution

VIMPAT® (lacosamide) CV Oral Solution Bottle Image

VIMPAT oral solution—a dosing option for patients who cannot swallow tablets2

  • Does not need to be refrigerated or shaken prior to administration
  • For accurate dosing, healthcare providers should offer a calibrated measuring device to patients prescribed VIMPAT oral solution
  • Any unused oral solution should be discarded after 6 months of first opening the bottle
  • VIMPAT oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of VIMPAT oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine
Oral Administration Chart

 

IMPORTANT SAFETY INFORMATION

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.

 

SELECT DOSING IN SPECIAL POPULATIONS2 |

  • 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. Dose titration should be performed with caution in all patients with renal and/or hepatic impairment
Select Dosing in Special Populations Chart

  • Dose supplementation: Following a 4-hour hemodialysis treatment, a dose supplementation of up to 50% of the last dose administered should be considered

Dose Adjustment Chart

 

  • Patients with hepatic or renal impairment taking strong inhibitors of CYP3A4 or CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients
  • Caution should be exercised for dose titration in elderly patients

MULTIPLE FORMULATIONS2:

Tablets: 60-count bottles
VIMPAT tablets should be
swallowed whole with liquid. Do not divide VIMPAT tablets

Injection solution
200 mg/20 mL:
single-use vial

Oral solution
10 mg/mL: 200 mL
 bottle

Unit-dose carton:
6 cards, 10 tablets each

(Formulations not shown at actual size.)

Convenient for the healthcare provider

  • Available in dosage strengths of 50 mg, 100 mg, 150 mg, and 200 mg
  • Multiple formulations
  • IV formulation requires no diluent, reconstitution, or refrigeration
    • Can be administered with or without common diluents
  • Oral solution may also be administered using a nasogastric or gastrostomy tube

Blood levels

  • No blood-level monitoring required

Pharmacokinetic profile

  • Approximately 100% oral bioavailability
  • VIMPAT injection is bioequivalent to oral VIMPAT when infused over 30 to 60 minutes*
  • Linear pharmacokinetics
  • Low protein binding (<15%)

Food and VIMPAT

  • Can be given with or without food
  • Food does not affect the rate or extent of absorption

For the 15-minute intravenous infusion, bioequivalence was met for AUC(0-tz) but not for Cmax. The point estimate of Cmax was 20% higher than Cmax for oral tablet and the 90% CI for Cmax exceeded the upper boundary of the bioequivalence range.

Reference

  1. 2.VIMPAT® (lacosamide): US prescribing information. Smyrna (GA): UCB, Inc.

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 for partial-onset seizures in patients 1 month to less than 17 years of age and for primary generalized tonic-clonic seizures for 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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