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.
The recommended posology for adults, adolescents and children from 2 years of age is summarised in the following table.
Lacosamide must be taken twice a day, approximately 12 hours apart.
If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. Patients should not take a double dose.
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 which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.
Lacosamide can also be initiated at the dose of 100 mg twice a 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 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. It is therefore recommended to initiate treatment with the syrup and switch to tablets, if desired. When prescribing the syrup, the dose should be expressed in volume (ml) rather than weight (mg).
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 syrup per intake depending on prescribed dose and body weight. The precise volume of syrup is to be calculated according to the exact body weight of the child. The calculated volume should be rounded to the nearest measuring device graduated increment. If the calculated volume is equidistant between two graduated increments, the larger graduated increment should be used (see Method of administration).
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 |
| Recommended device: 10 ml syringe for volume between 1 ml and 20 ml *30 ml measuring cup for volume more than 20 ml | ||||||
| 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) |
| For volume between 1 ml and 20 ml, the patient should be instructed to use the 10 ml oral syringe. *For volume above 20 ml, the patient should be instructed to use the 30 ml measuring cup. | ||||||
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 |
| Recommended device: 10 ml syringe for volume between 1 ml and 20 ml *30 ml measuring cup for volume more than 20 ml | |||||
| 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) |
| 1Dosage in adolescents 50 kg or more is the same as in adults. For volume between 1 ml and 20 ml, the patient should be instructed to use the 10 ml oral syringe. *For volume above 20 ml, the patient should be instructed to use the 30 ml measuring cup. | |||||
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 clearancecompared 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 syrup per intake depending on prescribed dose and body weight. The precise volume of syrup is to be calculated according to the exact body weight of thechild. The calculated volume should be rounded to the nearest measuring device graduated increment. If the calculated volume is equidistant between two graduated increments, the larger graduated increment should be used.
| 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 |
| Recommended device: 10 ml syringe for volume between 1 ml and 20 ml | ||||||
| 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) |
| 12 kg | 1.2 ml (12 mg) | 2.4 ml (24 mg) | 3.6 ml (36 mg) | 4.8 ml (48 mg) | 6 ml (60 mg) | 7.2 ml (72 mg) |
| 14 kg | 1.4 ml (14 mg) | 2.8 ml (28 mg) | 4.2 ml (42 mg) | 5.6 ml (56 mg) | 7 ml (70 mg) | 8.4 ml (84 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) |
| 16 kg | 1.6 ml (16 mg) | 3.2 ml (32 mg) | 4.8 ml (48 mg) | 6.4 ml (64 mg) | 8 ml (80 mg) | 9.6 ml (96 mg) |
| 18 kg | 1.8 ml (18 mg) | 3.6 ml (36 mg) | 5.4 ml (54 mg) | 7.2 ml (72 mg) | 9 ml (90 mg) | 10.8 ml (108 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 |
| Recommended device: 10 ml syringe for volume between 1 ml and 20 ml | |||||
| 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) |
| 22 kg | 2.2 ml (22 mg) | 4.4 ml (44mg) | 6.6 ml (66 mg) | 8.8 ml (88 mg) | 11 ml (110 mg) |
| 24 kg | 2.4 ml (24 mg) | 4.8 ml (48 mg) | 7.2 ml (72 mg) | 9.6 ml (96 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) |
| 26 kg | 2.6 ml (26 mg) | 5.2 ml (52 mg) | 7.8 ml (78 mg) | 10.4 ml (104 mg) | 13 ml (130 mg) |
| 28 kg | 2.8 ml (28 mg) | 5.6 ml (56 mg) | 8.4 ml (84 mg) | 11.2 ml (112 mg) | 14 ml (140 mg) |
Adjunctive therapy doses to be taken twice a day for children and adolescents weighing from 30 kg to less than 50 kg:
| 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 |
| Recommended device: 10 ml syringe for volume between 1 ml and 20 ml | ||||
| 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 mgtwice 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 undermedical 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.
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.
Lacosamide syrup must be taken orally.
The bottle containing Vimpat syrup should be shaken well before use. Lacosamide may be taken with or without food.
Lacosamide syrup is provided with:
The physician should instruct the patient on the appropriate measuring device to use.
If the required dose is between 10 mg (1 ml) and 100 mg (10 ml), the 10 ml oral syringe should be used.
If the required dose is between 100 mg (10 ml) and 200 mg (20 ml), the 10 ml oral syringe should be used two times.
If the required dose is more than 200 mg (20 ml), the 30 ml measuring cup should be used.
The dose should be rounded to the nearest graduated increment.
Instructions for use are provided in the package leaflet.
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.
After first opening: 6 months.
Do not refrigerate.
A 200 ml amber glass bottle with white polypropylene screw cap, a 30 ml measuring cup and a 10 ml oral syringe (black graduation marks) with an adaptor.
One full 30 ml measuring cup corresponds to 300 mg of lacosamide. The minimum volume is 5 ml which corresponds to 50 mg of lacosamide. As from the 5 ml graduation mark, each graduation mark corresponds to 5 ml which is 50 mg of lacosamide (for example 2 graduation marks correspond to 100 mg).
One full 10 ml oral syringe corresponds to 100 mg of lacosamide. The minimum extractable volume is 1 ml which corresponds to10 mg of lacosamide. As from the 1 ml graduation mark, each graduation mark corresponds to 0.25 ml which is 2.5 mg of lacosamide.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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