Approved October 29, 2008

LACOSAMIDE
(FDA Category 1S)

VIMPAT (UCB, Inc) is a functionalized amino acid whose precise antiepileptic mechanism is unknown.

DOSING INFORMATION: The usual initial recommended dose is 50 mg orally or intravenously twice daily. The dose may be increased at weekly intervals by 100 mg/day given as 2 divided doses up to a daily dose of 200 to 400 mg/day.

PHARMACOKINETICS: The absolute bioavailability of lacosamide after oral administration is approximately 100%. Maximum plasma concentrations are reached approximately 1 to 4 hours after oral dosing. Steady state plasma concentrations are reached within 3 days of twice daily continuous administration. The Vd of lacosamide is 0.6 L/kg and lacosamide is 15% bound to plasma proteins. Lacosamide is primarily eliminated by renal excretion and biotransformation. The elimination half-life of lacosamide is approximately 13 hours. The major O-desmethyl metabolite has a Tmax of 0.5 to 12 hours and an elimination half-life of 15 to 23 hours.

CAUTIONS: AEDs may increase the risk of suicidal thoughts or behaviors in patients. Caution is advised in patients with known cardiac conduction problems or severe cardiac disease such as myocardial ischemia or heart failure as dose-dependent prolongations in PR interval have been observed during clinical trials. Lacosamide may cause dizziness, ataxia, and/or syncope. Lacosamide should be gradually discontinued to minimize potential of increased seizure frequency. During clinical development, one case of multiorgan hypersensitivity reaction occurred.

FDA APPROVED INDICATIONS: Indicated as adjunctive therapy in the treatment of partial-onset seizures in patient with epilepsy aged 17 years and older. Lacosamide injection should be used when oral administration is temporarily not feasible.