LACOSAMIDE

LACOSAMIDE- lacosamide tablet, film coated
ScieGen Pharmaceuticals Inc

1 INDICATIONS AND USAGE

1.1 Partial-Onset Seizures

​ Lacosamide is indicated for the treatment of partial-onset seizures in patients 1 month 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 pediatric information.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage Information

​ The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures patients 4 years of age and older is included in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Dosage should be increased based on clinical response and tolerability, no more frequently than once per week. Titration increments should not exceed those shown in Table 1.

Table 1: Recommended Dosages for Partial-Onset Seizures (Monotherapy or Adjunctive Therapy) in Patients 4 years of age and Older*

Age and Body Weight	Initi al Dosage	Titration Regimen	Maintenance Dosage
Adults (17 years and older)	Monotherapy**: 100 mg twice daily (200 mg per day) Adjunctive Therapy: 50 mg twice daily (100 mg per day)	Increase by 50 mg twice daily (100 mg per day) every week	Monotherapy**: 150 mg to 200 mg twice daily (300 mg to 400 mg per day) Adjunctive Therapy: 100 mg to 200 mg twice daily (200 mg to 400 mg per day)
	Altern ate Initial Dosage: 200 mg single loading dose, followed 12 hours later by 100 mg twice daily
Pediatric patients weighing 50 kg or more	50 mg twice daily (100 mg per day)	​ Increase by 50 mg twice daily (100 mg per day) every week	Monotherapy**: 150 mg to 200 mg twice daily (300 mg to 400 mg per day) Adjunctive Therapy: 100 mg to 200 mg twice daily (200 mg to 400 mg per day)
​ Pediatric patients weighing 30 kg to less than 50 kg	​ 1 mg/kg twice daily (2 mg/kg/day)	​ Increase by 1 mg/kg twice daily (2 mg/kg/day) every week	​ 2 mg/kg to 4 mg/kg twice daily (4 mg/kg/day to 8 mg/kg/day)
Pediatric patients weighing 11 kg to less than 30 kg	​ 1 mg/kg twice daily (2 mg/kg/day)	​ Increase by 1 mg/kg twice daily (2 mg/kg/day) every week	​ 3 mg/kg to 6 mg/kg twice daily (6 mg/kg/day to 12 mg/kg/day)

​ *when not specified, the dosage is the same for monotherapy for partial-onset seizures and adjunctive therapy for partial-onset seizures.

​ **Monotherapy for partial-onset seizures only

In adjunctive clinical trials in adult patients, a dosage higher than 200 mg twice daily (400 mg per day) was not more effective and was associated with a substantially higher rate of adverse reactions [ see Adverse Reactions (6.1) and Clinical Studies (14.2)].

Loading Dose in Adult Patients (17 Years and Older)

Lacosamide tablets may be initiated in adult patients with a single loading dose of 200 mg, followed approximately 12 hours later by 100 mg twice daily (200 mg per day).

The maintenance dose regimen should be continued for one week. Lacosamide can then be titrated as recommended in Table 1. The adult loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions [ see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)].

The use of a loading dose in pediatric patients has not been studied.

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 pediatric information.

2.2 Converting From a Single Antiepileptic (AED) to Lacosamide Monotherapy for the Treatment of Partial-Onset Seizures

For patients who are already on a single AED and will convert to Lacosamide monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide is achieved and has been administered for at least 3 days. A gradual withdrawal of the concomitant AED over at least 6 weeks is recommended.

2.3 Dosage Information for Patients with Renal Impairment

For patients with mild to moderate renal impairment, no dosage adjustment is necessary.

For patients with severe renal impairment [creatinine clearance (CL _CR ) less than 30 mL/min as estimated by the Cockcroft-Gault equation for adults; CL _CR less than 30 mL/min/1.73m ² as estimated by the Schwartz equation for pediatric patients] or end-stage renal disease, a reduction of 25% of the maximum dosage is recommended.

In all patients with renal impairment, the dose titration should be performed with caution.

Hemodialysis

Lacosamide is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered.

Concomitant Strong CYP3A4 or CYP2C9 Inhibitors

Dose reduction may be necessary in patients with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 [ see Drug Interactions (7.1), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

2.4 Dosage Information for Patients with Hepatic Impairment

For patients with mild or moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. The dose titration should be performed with caution in patients with hepatic impairment. Lacosamide use is not recommended in patients with severe hepatic impairment.

Concomitant Strong CYP3A4 and CYP2C9 Inhibitors

Dose reduction may be necessary in patients with hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 [ see Drug Interactions (7.1), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].