NOW APPROVED

FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

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Darrell:
VIMPAT patient

INDICATION

VIMPAT® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

VIMPAT is indicated as 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

Expanding our commitment TO epilepsy care
for patients with partial-onset seizures.

VIMPAT adult efficacy for monotherapy and adjunctive therapy has been extrapolated for pediatric patients ages 4 and older.

Clinical data in adultsClinical data in children

Since being launched in the U.S. for adult adjunctive therapy in 2009, UCB has continued to bring VIMPAT to more patients with partial-onset seizures. VIMPAT is approved for monotherapy and adjunctive therapy in adults and children (ages 4 and older), with >500,000 patient exposures in the U.S.1

IN THE U.S.

2009

Launched for adult

ADJUNCTIVE THERAPY

2014

Approved for adult

MONOTHERAPY

2017

Approved for monotherapy and adjunctive therapy in

CHILDREN ≥4 YEARS OF AGE

PATIENT EXPERIENCE

>10

YEARS OF COMMITMENT TO PATIENTS—AND COUNTING

>500K

PATIENT EXPOSURES IN THE U.S.1

Simple dose conversion between formulations.

With VIMPAT, you have administration options. Choose between tablets, oral solution, and intravenous (IV) injection when oral administration is temporarily not feasible.

VIMPAT Dosing in AdultsVIMPAT Dosing in Children

(Formulations not shown at actual size.)

ACCESSIBILITY |

VIMPAT® (lacosamide) CV Patient Savings Card

UCB IS COMMITTED TO MAKING TREATMENT ACCESSIBLE

>95%

OF COMMERCIAL AND MEDICAID PATIENTS HAVE FORMULARY ACCESS TO VIMPAT® (LACOSAMIDE), AND MOST HAVE UNRESTRICTED ACCESS1

Learn How

WE'RE ALSO COMMITTED TO MAKING TREATMENT AFFORDABLE

Nearly 75% of eligible commercial patients* paid as little as $20 per 30-day supply of VIMPAT® with the VIMPAT Patient Savings Program1

Patients are responsible for a minimum of $20 out-of-pocket expense per 30-day supply. This card will then be applied toward any remaining out-of-pocket expense up to a maximum of $1300. If you have any questions regarding your eligibility or benefits or if you wish to discontinue your participation, call the VIMPAT Savings Program at 1-888-786-5879 (8:30 AM – 5:30 PM EST, Monday-Friday and 8:30 AM – 2:30 PM EST, Saturday). This savings card is not valid for use by patients who are covered by any federally funded or state-funded healthcare program (including, but not limited to, Medicare [Part D and Medigap], Medicaid, any state pharmaceutical assistance program, TRICARE, VA, or DoD). Offer good only in the US, including Puerto Rico. This card may only be used with a valid VIMPAT prescription at the time the prescription is filled by the pharmacist and dispensed to the patient. The maximum annual benefit amount is $1300 per calendar year. Void where prohibited by law, taxed, or restricted. This offer cannot be combined with any other promotional offer. UCB, Inc. reserves the right to rescind, revoke, or amend this offer without notice at any time. No cash value. Not eligible for sale, purchase, trade, or counterfeit.

STRIKE A BALANCE FOR YOUR PATIENTS. CHOOSE VIMPAT.

You can request samples through your UCB sales representative or by
calling ucbCARES® at 1-844-599-CARE (2273).

Reference

  1. Data on file. 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, seconddegree 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 multiorgan 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 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 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 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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