Lacosamide Injection

Lacosamide Injection is 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

Adults (17 years and older):

• Initial dosage for monotherapy for the treatment of partial-onset seizures is 100 mg twice daily

• Initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures is 50 mg twice daily

• 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

Injection: for intravenous use only when oral administration is temporarily not feasible; the recommended dosage is based on weight and is administered two or three times daily over 15 to 60 minutes; obtaining ECG before initiation is recommended in certain patients

Dose adjustment is recommended for severe renal impairment

Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended

• 200 mg/20 mL single-dose vial for intravenous use

None.

• Monitor patients for suicidal behavior and ideation

• Lacosamide Injection 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; closely monitor these patients

• Lacosamide Injection may cause syncope

• Lacosamide Injection should be gradually withdrawn to minimize the potential of increased seizure frequency

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity: Discontinue if no alternate etiology

• Adjunctive therapy: Most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence

• Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies

• Pediatric patients: Adverse reactions are similar to those seen in adult patients

• Pregnancy: Based on animal data, may cause fetal harm

Pediatric use information is approved for UCB, Inc.'s VIMPAT ®(lacosamide) injection. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.