Lacosamide

What it is and how it works

Mechanism of Action The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.

Indications

Lacosamide tablets are indicated for: • Treatment of partial-onset seizures in patients 4 years of age and older • Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older Partial-Onset Seizures Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Primary Generalized Tonic-Clonic Seizures Lacosamide tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

Dosage and administration (summary)

• Adults (17 years and older): o Initial dosage for monotherapy for the treatment of partial-onset seizures is 100 mg twice daily o Initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures is 50 mg twice daily o Maximum recommended dosage for monotherapy and adjunctive therapy is 200 mg twice daily • Pediatric Patients 4 years to less than 17 years: The recommended dosage is based on body weight and is administered orally twice daily • Increase dosage based on clinical response and tolerability, no more frequently than once per week • Dose adjustment is recommended for severe renal impairment ( 2.4 , 12.3 ) • Dose adjustme…

Contraindications

None. None

Warnings and precautions

• Monitor patients for suicidal behavior and ideation • Lacosamide may cause dizziness and ataxia • Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before beginning and after titration to steady-state maintenance is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as lacosamide, during pregnancy.

Storage and supply

How Supplied Lacosamide tablets, USP • 50 mg are pink coloured, biconvex, oval shaped, film coated tablets debossed with “T12” on one side and plain on the other side. They are supplied as follows: Bottles of 60 NDC 33342-302-09 Bottles of 100 NDC 33342-302-11 • 100 mg are yellow coloured, biconvex, oval shaped, film coated tablets debossed with “T…

Source: Lacosamide (Lacosamide) — US FDA prescribing information, 2024-06-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.