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VIMPAT

Last Updated: June 25, 2009

Manufacturer:

UCB Inc.

Pharmacological Class:

Antiepileptic (sodium channel inactivator)

Active Ingredient(s):

Lacosamide 50mg, 100mg, 150mg, 200mg; tabs.

Also:

VIMPAT INJECTION
Lacosamide 10mg/mL; soln for IV infusion.

Indication(s):

Tabs: Adjunct in partial-onset seizures.
Inj: Adjunct in partial-onset seizures, when oral administration is not feasible.

Pharmacology:

Lacosamide selectively enhances the slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. It also binds to collapsin response mediator protein-2, which is involved in neuronal differentiation and control of axonal growth. The exact mechanism of action of lacosamide in treating epilepsy is not known.

Lacosamide has been shown to have no significant pharmacokinetic interactions with carbamazepine or valproate. Steady-state plasma levels of concomitant antiepileptic drugs (AEDs) were unaffected by lacosamide.

Lacosamide is completely absorbed after oral administration. It has a bioavailability of about 100%. The 30- and 60-minute IV infusions are bioequivalent to the oral tablets.

Clinical Trials:

Three 12-week trials were conducted to establish the efficacy of lacosamide. These studies enrolled approximately 1300 patients with partial onset seizures with or without generalization who were not adequately controlled with 1 to 3 concomitant AEDs. In each study, an 8-week baseline phase was followed by randomization and a titration phase, then a maintenance phase that lasted 12 weeks during which patients remained on a stable dose of lacosamide. Study 1 compared lacosamide 200mg, 400mg, and 600mg/day to placebo; study 2 compared lacosamide 400mg and 600mg/day to placebo, and study 3 compared lacosamide 200mg and 400mg/day to placebo. The reduction in 28-day seizure frequency (baseline to maintenance phase) compared to placebo was the primary efficacy variable in each study.

At doses of 200mg, 400mg, and 600mg daily, lacosamide was shown to be significantly superior to placebo in reducing seizure frequency. The 600mg/day dose was not more effective than the 400mg/day dose.

Legal Classification:

Adults:

Inj: may give without diluting, or mix in appropriate diluent and give by IV infusion over 30–60min. For oral and inj: ≥17yrs: initially 50mg twice daily; may increase at weekly intervals by 100mg/day in 2 divided doses. Maintenance dose: 200–400mg/day. Renal impairment (CrCl ≤30mL/min), ESRD, mild-moderate hepatic impairment: max 300mg/day. Consider supplemental dose (50%) after hemodialysis. Avoid abrupt cessation (withdraw over 1 week).

Children:

<17yrs: not recommended.

Warnings/Precautions:

Severe hepatic impairment: not recommended. Cardiac conduction disturbances (eg, 2^nd degree AV block). Severe cardiac disease (eg, myocardial ischemia, heart failure). Monitor for suicidal ideation, depression. Diabetic neuropathy. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.