Lacosamide

LACOSAMIDE — lacosamide tablet, film coated
Aurobindo Pharma Limited

1 INDICATIONS AND USAGE

1.1 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 pediatric information.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage Information

The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures in 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^*

*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
Age and Body Weight	Initial 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)
Pediatric patients weighing at least 50 kg	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)

In adjunctive clinical trials in adult patients with partial-onset seizures, 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)].
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 Alternate Initial Dosage Information to Achieve the Maintenance Dosage in a Shorter Timeframe

For monotherapy and adjunctive therapy for partial-onset seizures in patients 4 years of age and older, an alternate initial dosing regimen for week 1 (e.g., including a loading dose and/or a higher initial dosage) may be administered in patients for whom achieving the recommended maintenance dosage in a shorter timeframe is clinically indicated (see Table 2). The alternate initial dosage regimen should be continued for one week. Lacosamide tablets may then be titrated based on clinical response and tolerability, ​no more frequently than once per week, if needed. The loading dose should be administered with medical supervision because of the possibility of increased incidence of adverse reactions, including central nervous system (CNS) and cardiovascular adverse reactions [see Warnings and Precautions (5.2, 5.3), Adverse Reactions (6.1), and Clinical Pharmacology (12.3)]. Titration increments should not exceed those shown in Table 2.

Table 2: Alternate Initial Dosing Regimen to Achieve the Maintenance Dosage in a Shorter Timeframe if Clinically Indicated^*

*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
Age and Body Weight	Alternate Initial Dosage	Titration Regimen	Maintenance Dosage
Adults (17 years and older)	Single loading dose: 200 mg 12 hours later initiate: 100 mg twice daily (200 mg per day)	Increase by 50 mg twice daily (100 mg per day)at weekly intervals, if needed	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 at least 50 kg	Single loading dose: 200 mg 12 hours later initiate: 100 mg twice daily (200 mg per day)	Increase by 50 mg twice daily (100 mg per day)at weekly intervals, if needed	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	Single loading dose: 4 mg/kg 12 hours later initiate: 2 mg/kg twice daily (4 mg/kg/day)	Increase by 1 mg/kg twice daily (2 mg/kg/day) at weekly intervals, if needed	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	Single loading dose: 4.5 mg/kg 12 hours later initiate: 3 mg/kg twice daily (6 mg/kg/day)	Increase by 1 mg/kg twice daily (2 mg/kg/day) at weekly intervals, if needed	3 mg/kg to 6 mg/kg twice daily(6 mg/kg/day to 12 mg/kg/day)

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.

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

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