Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
Vimpat is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.
Vimpat is indicated as adjunctive therapy:
The physician should prescribe the most appropriate formulation and strength according to weight and dose.
Lacosamide therapy can be initiated with either oral administration (either tablets or syrup) or intravenous administration (solution for infusion). Solution for infusion is an alternative for patients when oral administration is temporarily not feasible. The overall duration of treatment with intravenous lacosamide is at the physician’s discretion; there is experience from clinical studies with twice daily infusions of lacosamide for up to 5 days in adjunctive therapy. Conversion to or from oral and intravenous administration can be done directly without titration. The total daily dose and twice daily administration should be maintained. Monitor closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (e.g. myocardial ischemia, heart failure) when lacosamide dose is higher than 400 mg/day (see Method of administration below and section 4.4).
Lacosamide must be taken twice a day (approximately 12 hours apart).
The recommended posology for adults, adolescents and children from 2 years of age is summarised in the following table.
Adolescents and children weighing 50 kg or more, and adults:
| Starting dose | Titration (incremental steps) | Maximum recommended dose |
| Monotherapy: 50 mg twice a day (100 mg/day) or 100 mg twice a day (200 mg/day) Adjunctive therapy: 50 mg twice a day (100 mg/day) | 50 mg twice a day (100 mg/day) at weekly intervals | Monotherapy: up to 300 mg twice a day (600 mg/day) Adjunctive therapy: up to 200 mg twice a day (400 mg/day) |
| Alternate initial dosage* (If applicable): 200 mg single loading dose followed by 100 mg twice a day (200 mg/day) | ||
* A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8). Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
Children from 2 years of age and adolescents weighing less than 50 kg:
| Starting dose | Titration (incremental steps) | Maximum recommended dose |
| Monotherapy and Adjunctive therapy: 1 mg/kg twice a day (2 mg/kg/day) | 1 mg/kg twice a day (2 mg/kg/day) at weekly intervals | Monotherapy: - up to 6 mg/kg twice a day (12 mg/kg/day) in patients ≥10 kg to <40 kg - up to 5 mg/kg twice a day (10 mg/kg/day) in patients ≥40 kg to <50 kg |
| Adjunctive therapy: - up to 6 mg/kg twice a day (12 mg/kg/day) in patients ≥10 kg to <20 kg - up to 5 mg/kg twice a day (10 mg/kg/day) in patients ≥20 kg to <30 kg - up to 4 mg/kg twice a day (8 mg/kg/day) in patients ≥30 kg to <50 kg |
The recommended starting dose is 50 mg twice a day (100 mg/day) which should be increased to an initial therapeutic dose of 100 mg twice a day (200 mg/day) after one week.
Lacosamide can also be initiated at the dose of 100 mg twice a day (200 mg/day) based on the physician’s assessment of required seizure reduction versus potential side effects.
Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day).
In patients having reached a dose greater than 200 mg twice a day (400 mg/day) and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.
The recommended starting dose is 50 mg twice a day (100 mg/day) which should be increased to an initial therapeutic dose of 100 mg twice a day (200 mg/day) after one week.
Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 200 mg twice a day (400 mg/day).
The dose is determined based on body weight.
The recommended starting dose is 1 mg/kg twice a day (2 mg/kg/day) which should be increased to an initial therapeutic dose of 2 mg/kg twice a day (4 mg/kg/day) after one week. Depending on response and tolerability, the maintenance dose can be further increased by 1 mg/kg twice a day (2 mg/kg/day) every week. The dose should be gradually increased until the optimum response is obtained. The lowest effective dose should be used. In children weighing from 10 kg to less than 40 kg, a maximum dose of up to 6 mg/kg twice a day (12 mg/kg/day) is recommended. In children weighing from 40 to under 50 kg, a maximum dose of 5 mg/kg twice a day (10 mg/kg/day) is recommended.
The tables below provide examples of volumes of solution for infusion per administration depending on prescribed dose and body weight. The precise volume of solution for infusion is to be calculated according to the exact body weight of the child.
Monotherapy doses in the treatment of partial-onset seizures to be taken twice a day for children from 2 years of age weighing from 10 kg to less than 40 kg:
| Week | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 |
| Prescribed dose | 0.1 ml/kg (1 mg/kg) Starting dose | 0.2 ml/kg (2 mg/kg) | 0.3 ml/kg (3 mg/kg) | 0.4 ml/kg (4 mg/kg) | 0.5 ml/kg (5 mg/kg) | 0.6 ml/kg (6 mg/kg) Maximum recommended dose |
| Weight | Volume administered | |||||
| 10 kg | 1 ml (10 mg) | 2 ml (20 mg) | 3 ml (30 mg) | 4 ml (40 mg) | 5 ml (50 mg) | 6 ml (60 mg) |
| 15 kg | 1.5 ml (15 mg) | 3 ml (30 mg) | 4.5 ml (45 mg) | 6 ml (60 mg) | 7.5 ml (75 mg) | 9 ml (90 mg) |
| 20 kg | 2 ml (20 mg) | 4 ml (40 mg) | 6 ml (60 mg) | 8 ml (80 mg) | 10 ml (100 mg) | 12 ml (120 mg) |
| 25 kg | 2.5 ml (25 mg) | 5 ml (50 mg) | 7.5 ml (75 mg) | 10 ml (100 mg) | 12.5 ml (125 mg) | 15 ml (150 mg) |
| 30 kg | 3 ml (30 mg) | 6 ml (60 mg) | 9 ml (90 mg) | 12 ml (120 mg) | 15 ml (150 mg) | 18 ml (180 mg) |
| 35 kg | 3.5 ml (35 mg) | 7 ml (70 mg) | 10.5 ml (105 mg) | 14 ml (140 mg) | 17.5 ml (175 mg) | 21 ml* (210 mg) |
Monotherapy doses in the treatment of partial-onset seizures to be taken twice a day for children and adolescents weighing from 40 kg to less than 50 kg1:
| Week | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 |
| Prescribed dose | 0.1 ml/kg (1 mg/kg) Starting dose | 0.2 ml/kg (2 mg/kg) | 0.3 ml/kg (3 mg/kg) | 0.4 ml/kg (4 mg/kg) | 0.5 ml/kg (5 mg/kg) Maximum recommended dose |
| Weight | Volume administered | ||||
| 40 kg | 4 ml (40 mg) | 8 ml (80 mg) | 12 ml (120 mg) | 16 ml (160 mg) | 20 ml (200 mg) |
| 45 kg | 4.5 ml (45 mg) | 9 ml (90 mg) | 13.5 ml (135 mg) | 18 ml (180 mg) | 22.5 ml (225 mg) |
1 Dosage in adolescents 50 kg or more is the same as in adults.
The recommended starting dose is 1 mg/kg twice a day (2 mg/kg/day) which should be increased to an initial therapeutic dose of 2 mg/kg twice a day (4 mg/kg/day) after one week.
Depending on response and tolerability, the maintenance dose can be further increased by 1 mg/kg twice a day (2 mg/kg/day) every week. The dose should be gradually adjusted until the optimum response is obtained. The lowest effective dose should be used. Due to an increased clearance compared to adults, in children weighing from 10 kg to less than 20 kg, a maximum dose of up to 6 mg/kg twice a day (12 mg/kg/day) is recommended. In children weighing from 20 to under 30 kg, a maximum dose of 5 mg/kg twice a day (10 mg/kg/day) is recommended and in children weighing from 30 to under 50 kg, a maximum dose of 4 mg/kg twice a day (8 mg/kg/day) is recommended, although in open-label studies (see sections 4.8 and 5.2), a dose up to 6 mg/kg twice a day (12 mg/kg/day) has been used by a small number of children from this latter group.
The tables below provide examples of volumes of solution for infusion per administration depending on prescribed dose and body weight. The precise volume of solution for infusion is to be calculated according to the exact body weight of the child.
Adjunctive therapy doses to be taken twice a day for children from 2 years of age weighing from 10 kg to less than 20 kg:
| Week | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 |
| Prescribed dose | 0.1 ml/kg (1 mg/kg) Starting dose | 0.2 ml/kg (2 mg/kg) | 0.3 ml/kg (3 mg/kg) | 0.4 ml/kg (4 mg/kg) | 0.5 ml/kg (5 mg/kg) | 0.6 ml/kg (6 mg/kg) Maximum recommended dose |
| Weight | Volume administered | |||||
| 10 kg | 1 ml (10 mg) | 2 ml (20 mg) | 3 ml (30 mg) | 4 ml (40 mg) | 5 ml (50 mg) | 6 ml (60 mg) |
| 15 kg | 1.5 ml (15 mg) | 3 ml (30 mg) | 4.5 ml (45 mg) | 6 ml (60 mg) | 7.5 ml (75 mg) | 9 ml (90 mg) |
Adjunctive therapy doses to be taken twice a day for children and adolescents weighing from 20 kg to less than 30 kg:
| Week | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 |
| Prescribed dose | 0.1 ml/kg (1 mg/kg) Starting dose | 0.2 ml/kg (2 mg/kg) | 0.3 ml/kg (3 mg/kg) | 0.4 ml/kg (4 mg/kg) | 0.5 ml/kg (5 mg/kg) Maximum recommended dose |
| Weight | Volume administered | ||||
| 20 kg | 2 ml (20 mg) | 4 ml (40 mg) | 6 ml (60 mg) | 8 ml (80 mg) | 10 ml (100 mg) |
| 25 kg | 2.5 ml (25 mg) | 5 ml (50 mg) | 7.5 ml (75 mg) | 10 ml (100 mg) | 12.5 ml (125 mg) |
Adjunctive therapy doses to be taken twice a day for children and adolescents weighing from 30 kg to less than 50 k:
| Week | Week 1 | Week 2 | Week 3 | Week 4 |
| Prescribed dose | 0.1 ml/kg (1 mg/kg) Starting dose | 0.2 ml/kg (2 mg/kg) | 0.3 ml/kg (3 mg/kg) | 0.4 ml/kg (4 mg/kg) Maximum recommended dose |
| Weight | Volume administered | |||
| 30 kg | 3 ml (30 mg) | 6 ml (60 mg) | 9 ml (90 mg) | 12 ml (120 mg) |
| 35 kg | 3.5 ml (35 mg) | 7 ml (70 mg) | 10.5 ml (105 mg) | 14 ml (140 mg) |
| 40 kg | 4 ml (40 mg) | 8 ml (80 mg) | 12 ml (120 mg) | 16 ml (160 mg) |
| 45 kg | 4.5 ml (45 mg) | 9 ml (90 mg) | 13.5 ml (135 mg) | 18 ml (180 mg) |
In adolescents and children weighing 50 kg or more, and adults, lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. Subsequent dose adjustments should be performed according to individual response and tolerability as described above. A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8). Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
If lacosamide has to be discontinued, it is recommended that the dose is reduced gradually in weekly decrements of 4 mg/kg/day (for patients with a body weight less than 50 kg) or 200 mg/day (for patients with a body weight of 50 kg or more) for patients who have achieved a dose of lacosamide ≥6 mg/kg/day or ≥300 mg/day, respectively. A slower taper in weekly decrements of 2 mg/kg/day or 100 mg/day can be considered, if medically necessary.
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.
No dose reduction is necessary in elderly patients. Age associated decreased renal clearance with an increase in AUC levels should be considered in elderly patients (see following paragraph ‘renal impairment’ and section 5.2). There is limited clinical data in the elderly patients with epilepsy, particularly at doses greater than 400 mg/day (see sections 4.4, 4.8, and 5.1).
No dose adjustment is necessary in mildly and moderately renally impaired adult and paediatric patients (CLCR >30 ml/min). In paediatric patients weighing 50 kg or more and in adult patients with mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose titration (>200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤30 ml/min) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed with caution. If a loading dose is indicated, an initial dose of 100 mg followed by a 50 mg twice daily regimen for the first week should be used. In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤30 ml/min) and in those with end-stage renal disease, a reduction of 25% of the maximum dose is recommended. For all patients requiring haemodialysis a supplement of up to 50% of the divided daily dose directly after the end of haemodialysis is recommended. Treatment of patients with end-stage renal disease should be made with caution as there is little clinical experience and accumulation of a metabolite (with no known pharmacological activity).
A maximum dose of 300 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with mild to moderate hepatic impairment. The dose titration in these patients should be performed with caution considering co-existing renal impairment. In adolescents and adults weighing 50 kg or more, a loading dose of 200 mg may be considered, but further dose titration (>200 mg daily) should be performed with caution. Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment, a reduction of 25% of the maximum dose should be applied. The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see section 5.2). Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient.
Lacosamide is not recommended for use in children below the age of 4 years in the treatment of primary generalized tonic-clonic seizures and below the age of 2 years in the treatment of partial-onset seizures as there is limited data on safety and efficacy in these age groups, respectively.
Administration of a loading dose has not been studied in children. Use of a loading dose is not recommended in adolescents and children weighing less than 50 kg.
The solution for infusion is infused over a period of 15 to 60 minutes twice a day. An infusion duration of at least 30 minutes for administration >200 mg per infusion (i.e. >400 mg/day) is preferred.
Vimpat solution for infusion can be administered intravenously without further dilution or can be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection, glucose 50 mg/ml (5%) solution for injection or lactated Ringer’s solution for injection.
Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
There is no specific antidote for overdose with lacosamide. Treatment of lacosamide overdose should include general supportive measures and may include haemodialysis if necessary (see section 5.2).
3 years.
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for product mixed with the diluents mentioned in 6.6 and stored in glass or PVC bags.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Do not store above 25°C.
For storage conditions after dilution of the medicinal product, see section 6.3.
Colourless type I glass vial with a chlorobutyl rubber closure coated with a fluoropolymer. Packs of 1x20 ml and 5x20 ml.
Not all pack sizes may be marketed.
Product with particulate matter or discolouration should not be used.
This medicinal product is for single use only, any unused solution should be discarded. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Vimpat solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in glass or PVC bags at temperatures up to 25°C.
Diluents:
sodium chloride 9 mg/ml (0.9%) solution for injection
glucose 50 mg/ml (5%) solution for injection
lactated Ringer’s solution for injection.
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