Drug Detail:Vimpat (Lacosamide (oral/injection) [ la-koe-sa-mide ])
Generic Name: LACOSAMIDE 50mg
Drug Class: Miscellaneous anticonvulsants
Dosage Information
The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures in patients 1 month of age and older and for adjunctive therapy for primary generalized tonic-clonic 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.
| 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) |
| Pediatric patients weighing 6 kg to less than 11 kg ‡ | |||
| Pediatric patients weighing less than 6 kg ‡ | Intravenous: 0.66 mg/kg three times daily (2 mg/kg/day) |
Intravenous: Increase by 0.66 mg/kg three times daily (2 mg/kg/day) every week |
Intravenous: 2.5 mg/kg to 5 mg/kg three times daily (7.5 mg/kg/day to 15 mg/kg/day) |
| Oral: 1 mg/kg twice daily (2 mg/kg/day) |
Oral: Increase by 1 mg/kg twice daily (2 mg/kg/day) every week |
Oral: 3.75 mg/kg to 7.5 mg/kg twice daily (7.5 mg/kg/day to 15 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)].
VIMPAT Injection Dosage
VIMPAT injection may be used when oral administration is temporarily not feasible [see Dosage and Administration (2.6) and Warnings and Precautions (5.3)]. VIMPAT injection can be administered intravenously to adult and pediatric patients weighing 6 kg or more with the same dosing regimens described for oral dosing. For pediatric patients weighing less than 6 kg, VIMPAT injection may be initiated with a dose of 0.66 mg/kg three times daily (see Table 1).
The clinical study experience of intravenous VIMPAT is limited to 5 days of consecutive treatment.
Alternate Initial Dosage Information to Achieve the Maintenance Dosage in a Shorter Timeframe
For monotherapy and adjunctive therapy for partial-onset seizures in patients 1 month of age and older and for adjunctive therapy for primary generalized tonic-clonic 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. VIMPAT 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.
| 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) |
| Pediatric patients weighing 6 kg to less than 11 kg ‡ | |||
| Pediatric patients weighing less than 6 kg ‡ | Intravenous: No loading dose required 2.5 mg/kg three times daily (7.5 mg per day) |
Intravenous: Increase by 0.66 mg/kg three times daily (2 mg/kg/day) at weekly intervals, if needed |
Intravenous: 2.5 mg/kg to 5 mg/kg three times daily (7.5 mg/kg/day to 15 mg/kg/day) |
| Oral: No loading dose required 3.75 mg/kg twice daily (7.5 mg per day) |
Oral: Increase by 1 mg/kg twice daily (2 mg/kg/day) at weekly intervals, if needed |
Oral: 3.75 mg/kg to 7.5 mg/kg twice daily (7.5 mg/kg/day to 15 mg/kg/day) |
|
Converting From a Single Antiepileptic (AED) to VIMPAT Monotherapy for the Treatment of Partial-Onset Seizures
For patients who are already on a single AED and will convert to VIMPAT monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of VIMPAT 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.
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 (CLCR) less than 30 mL/min as estimated by the Cockcroft-Gault equation for adults; CLCR less than 30 mL/min/1.73m2 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, dose initiation and titration should be based on clinical response and tolerability.
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 initiation and titration should be based on clinical response and tolerability in patients with hepatic impairment.
VIMPAT use is not recommended in patients with severe hepatic impairment.
Administration Instructions for VIMPAT Tablets and Oral Solution
VIMPAT tablets and oral solution may be taken with or without food.
VIMPAT Oral Solution
A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.
VIMPAT oral solution may also be administered using a nasogastric tube or gastrostomy tube.
Discard any unused VIMPAT oral solution remaining after 6 months of first opening the bottle.
Preparation and Administration Information for VIMPAT Injection
Preparation
VIMPAT injection can be administered intravenously without further dilution or may be mixed with diluents listed below. The diluted solution should not be stored for more than 4 hours at room temperature.
Diluents:
Sodium Chloride Injection 0.9% (w/v)
Dextrose Injection 5% (w/v)
Lactated Ringer's Injection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used.
VIMPAT injection is for single-dose only. Any unused portion of VIMPAT injection should be discarded.
Administration
The recommended infusion duration is 30 to 60 minutes; however, infusions as rapid as 15 minutes can be administered in adults if required [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)]. Infusion durations less than 30 minutes are generally not recommended in pediatric patients [see Adverse Reactions (6.1)].
Intravenous infusion of VIMPAT may cause bradycardia, AV blocks, and ventricular tachyarrhythmia [see Warnings and Precautions (5.3)]. Obtaining an ECG before beginning VIMPAT and after VIMPAT is titrated to steady-state maintenance dose is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction [see Drug Interactions (7.2)].
