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).

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 are similar to those seen in adult patients.

VIMPAT is a Schedule V controlled substance.

View full Prescribing Information

MONOTHERAPY AND ADJUNCTIVE THERAPY FOR PEDIATRIC PATIENTS|

Prescribe the most appropriate oral formulation and strength according to the weight-based dosing.

DOSAGE AND ADMINISTRATION FOR MONOTHERAPY AND ADJUNCTIVE THERAPY
PEDIATRIC PATIENTS 4 YEARS TO <17 YEARS
VIMPAT® (lacosamide) CV Weight-Based Dosage Chart
VIMPAT® (lacosamide) CV Weight-Based Dosage Chart

Titrate based on tolerability and response.

  • 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). The use of a loading dose has not been studied in pediatric patients
  • Dose reduction of 25% of the maximum dose is recommended in pediatric patients with severe renal impairment or end-stage renal disease. In all patients with renal impairment, the dose titration should be performed with caution
  • Dose reduction of 25% of the maximum dose is recommended in pediatric patients with mild to moderate hepatic impairment. VIMPAT use is not recommended in patients with severe hepatic impairment. The dose titration should be performed with caution in patients with hepatic impairment
  • Maintain a therapeutic dose of VIMPAT for at least 3 days before withdrawing concomitant AED. A gradual withdrawal over at least 6 weeks is recommended
  • Gradually withdraw VIMPAT (over a minimum of 1 week) to minimize the potential of increased seizure frequency

ORAL SOLUTION2 |

An option when patients cannot swallow tablets

VIMPAT® (lacosamide) CV Strawberry-Flavored Oral Solution Image

(Strawberry-flavored oral solution)

Instructions for Use:

  • Same dose and frequency as tablet
  • Can be taken with or without food
    • Does not need to be refrigerated or shaken prior to administration
  • Oral solution may also be administered using a nasogastric or gastrostomy tube
VIMPAT® (lacosamide) CV Oral Administration Chart

SELECT 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
VIMPAT® (lacosamide) CV Renal Impairment Dosing Chart

Dose supplementation

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

VIMPAT® (lacosamide) CV Hepatic Impairment Dosing Chart

Safety Considerations

  • 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

MULTIPLE FORMULATIONS AND A SIMPLE 1:1 DOSE CONVERSION |

Oral solution
10 mg/mL: 200 mL and
465 mL bottles

Tablets:
60-count bottles

(Formulations not shown at actual size.)

Convenient for the healthcare provider

  • Available in oral solution (10 mg/mL) and tablets (50 mg, 100 mg, 150 mg, and 200 mg)
  • Oral solution can be stored at room temperature
  • Oral solution may also be administered using a nasogastric or gastrostomy tube
  • Simple 1:1 dose conversion

Blood levels

  • No blood-level monitoring required

Pharmacokinetic profile

  • Approximately 100% oral bioavailability
  • 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

Reference

  1. 2.VIMPAT® (lacosamide): US prescribing information. Smyrna (GA): UCB, Inc., November 2017.

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).