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Adverse events seen with Vimpat were generally mild to moderate and dose related.

Chart: Most common adverse events (percent) occuring in greater than or equal to 2 percent of patients with Vimpat and placebo as adjunctive therapy

* AEs reported with the total number of patients treated with Vimpat 200 mg/day, 400 mg/day, and 600 mg/day. Therapeutic dosing range with Vimpat is 200 mg/day to 400 mg/day. 600 mg/day is not an approved dose.
^† The number of patients decreased from forced titration to maintenance phase.

Patients in these clinical trials were treated with 1 to 3 concomitant antiepileptic drugs
Discontinuation rates due to adverse events for patients treated with Vimpat 200 mg/day and Vimpat 400 mg/day were 8% and 17%, respectively, vs 5% for those receiving placebo

Vimpat demonstrated safety and tolerability benefits

* Pharmacokinetic.
^† Contraceptives include ethinylestradiol
0.03 mg and levonorgestrel 0.15 mg.

Indication

Vimpat^® (lacosamide) 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

AEDs 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 should be advised that Vimpat may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with 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

The most common adverse reactions occurring in ≥10 percent of Vimpat-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.

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.

Please see Vimpat Prescribing Information.