Lacosamide

LACOSAMIDE- lacosamide tablet
Tris Pharma Inc

1 INDICATIONS AND USAGE

1.1 Partial-Onset Seizures

Lacosamide tablets is 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*

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)

*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 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)].

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 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*

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)

*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
± indicated only for partial-onset seizures.

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