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.
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.
IN THE U.S.
Since being approved for adult adjunctive therapy in 2009, UCB has continued to bring VIMPAT to more patients with partial-onset seizures. VIMPAT is now approved for monotherapy and adjunctive therapy in adults and children (ages 4 and older), with >350,000 adult patient exposures in the U.S.1
2009
Approved for adult
ADJUNCTIVE THERAPY
2014
Approved for adult
MONOTHERAPY
2017
Approved for monotherapy and adjunctive therapy in
CHILDREN ≥4 YEARS OF AGE
ADULT EXPERIENCE
YEARS OF COMMITMENT TO ADULT PATIENTS—AND COUNTING
ADULT PATIENT EXPOSURES IN THE U.S.1
Simple dose conversion between formulations.
With VIMPAT, you have administration options. Choose between tablets and oral solution for pediatric and adult patients. Intravenous [IV] injection solution is also available for adult patients. 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).
(Formulations not shown at actual size.)
Patients paid as little
as $20 for a 30-day
supply of VIMPAT.1*
VIMPAT IS COVERED BY MOST COMMERCIAL AND MEDICAID PLANS.
Eligibility Criteria & Terms: 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 $100. Most patients who have commercial prescription insurance are eligible. 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 federal 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 U.S., including Puerto Rico. This card is good for use only 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.
You can request samples through your UCB sales representative or by
calling UCBCares® at 1-844-599-CARE (2273).
Reference
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).
UCB, Inc.
Smyrna, GA 30080
UCB.com
