Tools for Your Practice
You can request the 2-week sample kit either through your UCB sales representative or by calling UCB Customer Service at 1-800-477-7877. When connected, please dial 7 to reach a representative.
Choose VIMPAT for the adjunctive treatment of partial-onset seizures in adults with epilepsy.
INDICATION: VIMPAT® tablets and oral solution are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are 17 years and older. VIMPAT® injection is indicated as short-term replacement when oral administration is not feasible in these patients.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Antiepileptic drugs (AEDs), including VIMPAT, increase the risk of suicidal behavior and ideation. Patients taking VIMPAT should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients and caregivers should also be advised to be alert for these behavioral changes and to immediately report them to the healthcare provider.
Patients should be advised that VIMPAT may cause dizziness and ataxia. Therefore patients should not drive a car or operate complex machinery until they are familiar with the effects of VIMPAT on their ability to perform such activities.
Dose-dependent PR interval prolongation has been observed in VIMPAT clinical studies in patients and in healthy volunteers. When VIMPAT is given with other drugs that prolong the PR interval, further PR prolongation is possible. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheadedness and fainting) and told to contact their physician should any of these occur. VIMPAT should be used with caution in patients with known cardiac conduction problems or with severe cardiac disease. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady state, is recommended.
VIMPAT administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease. Patients should be made aware of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid pulse, shortness of breath) and told to contact their physician should these symptoms occur.
Patients should be advised that VIMPAT may cause syncope.
VIMPAT should be gradually withdrawn (over a minimum of 1 week) to minimize the potential of increased seizure frequency.
Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, VIMPAT should be discontinued.
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.
Common Adverse Reactions
In 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.
VIMPAT is a Schedule V controlled substance.
Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in severe hepatic impairment patients is not recommended. Dose titration should be performed with caution in all renally impaired patients.
In clinical trials, adverse reactions with intravenous administration generally appeared similar to those observed with the oral formulation, although intravenous administration was associated with local adverse events such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%).
Please see VIMPAT Prescribing Information