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LACOSAMIDE NOVUMGEN is a brand name for Lacosamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lacosamide 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. Lacosamide is indicated as adjunctive therapy • in the treatment of partial-onset seizures with or without secondary…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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) Monotherapy: up to 300 mg twice a day (600 mg/day) Adjunctive therapy: 50 mg twice a day (100 mg/day) 50 mg twice a day (100 mg/day) at weekly intervals 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.
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 Adolescents and children weighing 50 kg or more, and adults Monotherapy (in the treatment of partial-onset seizures) 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.
2 % of patients randomised to placebo reported at least 1 adverse reaction. The most frequently reported adverse reactions (≥ 10 %) with lacosamide treatment were dizziness, headache, nausea and diplopia. They were usually mild to moderate in intensity.
Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of central nervous system (CNS) and gastrointestinal (GI) adverse reactions usually decreased over time. 6 % for patients randomised to placebo.
The most common adverse reaction resulting in discontinuation of lacosamide therapy was dizziness. Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. Based on the analysis of data from a non-inferiority monotherapy clinical study comparing lacosamide to carbamazepine controlled release (CR), the most frequently reported adverse reactions (≥ 10 %) for lacosamide were headache and dizziness.
6 % for patients treated with carbamazepine CR. The safety profile of lacosamide reported in a study conducted in patients aged 4 years and older with idiopathic generalised epilepsy with primary generalised tonic- clonic seizures (PGTCS) was consistent with the safety profile reported from the pooled placebo-controlled clinical studies in partial-onset seizures.
3 % in the lacosamide- group and 0 % in the placebo-group). The most frequently reported adverse reactions were dizziness and somnolence. The most common adverse reactions resulting in discontinuation of lacosamide therapy were dizziness and suicidal ideation.
1 % in the placebo group. Tabulated list of adverse reactions The table below shows the frequencies of adverse reactions which have been reported in clinical studies and post-marketing experience. The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be estimated from available data).
Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications. A meta-analysis of randomised placebo-controlled clinical studies of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lacosamide. Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
8). Cardiac rhythm and conduction Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies. g. 5), as well as in elderly patients. In these patients it should be considered to perform an ECG before a lacosamide dose increase above 400 mg/day and after lacosamide is titrated to steady-state.
In the placebo-controlled clinical studies of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however, both have been reported in open- label epilepsy studies and in post-marketing experience. In post-marketing experience, AV block (including second degree or higher AV block) has been reported.
In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported. In rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying proarrhythmic conditions. g. slow, rapid or irregular pulse, palpitations, shortness of breath, feeling lightheaded, fainting).
Patients should be counselled to seek immediate medical advice if these symptoms occur. Dizziness Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls. 8). Potential for new onset or worsening of myoclonic seizures New onset or worsening of myoclonic seizures has been reported in both adult and paediatric patients with PGTCS, in particular during titration.
1. Known second- or third-degree atrioventricular (AV) block.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary generalised tonic-clonic seizures) 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). Children from 2 years of age and adolescents weighing less than 50 kg 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). Monotherapy (in the treatment of partial-onset seizures) 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). 5 ml (75 mg) 9 ml (90 […]
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System organ class Very common Common Uncommon Not known Blood and lymphatic disorders Agranulocytosis(1) Immune system disorders Drug hypersensitivity(1) Drug reaction with eosinophilia and systemic symptoms (DRESS) (1,2) Psychiatric disorders Depression Confusional state Insomnia(1) Aggression Agitation(1) Euphoric mood(1) Psychotic disorder(1) Suicide attempt (1) Suicidal ideation Hallucination (1) Nervous system disorders Dizziness Headache Myoclonic seizures(3) Ataxia Balance disorder Memory impairment Syncope(2) Coordination abnormal Dyskinesia Convulsion Cognitive disorder Somnolence Tremor Nystagmus Hypoesthesia Dysarthria Disturbance in attention Paraesthesia Eye disorders Diplopia Vision blurred Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Atrioventricular block(1,2) Bradycardia(1,2) Atrial Fibrillation (1,2) Atrial Flutter (1,2) Ventricular tachyarrhythmia (1) Gastrointestinal disorders Nausea Vomiting Constipation Flatulence Dyspepsia Dry mouth Diarrhoea Hepatobiliary disorders Liver function test abnormal(2) Hepatic enzyme increased (> 2x ULN) (1) Skin and subcutaneous tissue disorders Pruritus Rash(1) Angioedema(1) Urticaria(1) Stevens-Johnson syndrome(1) Toxic epidermal necrolysis(1) Musculoskeletal and connective tissue disorders Muscle spasms General disorders and administration site conditions Gait disturbance Asthenia Fatigue Irritability Feeling drunk Injury, poisoning and procedural complications Fall Skin laceration Contusion (1) Adverse reactions reported in post-marketing experience.
(2) See Description of selected adverse reactions. (3) Reported in PGTCS studies. Description of selected adverse reactions The use of lacosamide is associated with dose-related increase in the PR interval. g. atrioventricular block, syncope, bradycardia) may occur.
5 % and 0 % for lacosamide 200 mg, 400 mg, 600 mg or placebo, respectively. No second- or higher degree AV Block was seen in these studies. However, cases with second- and third-degree AV Block associated with lacosamide treatment have been reported in post-marketing experience.
In the monotherapy clinical study comparing lacosamide to carbamazepine CR, the extent of increase in PR interval was comparable between lacosamide and carbamazepine. 3 %). 2 %) carbamazepine CR patients. Atrial fibrillation or flutter were not reported in short term clinical studies; however, both have been reported in open-label epilepsy studies and in post-marketing experience.
Laboratory abnormalities Abnormalities in liver function tests have been observed in placebo-controlled clinical studies with lacosamide in adult patients with partial-onset […]
In patients with more than one seizure type, the observed benefit of control for one seizure type should be weighed against any observed worsening in another seizure type. Potential for electro-clinical worsening in specific paediatric epilepsy syndromes The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined.
Excipients Excipients which may cause intolerance Lacosamide contains Sodium Methyl parahydroxybenzoate (E219), which may cause allergic reactions (possibly delayed). Lacosamide contains Sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Lacosamide contains Aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
Lacosamide contains Propylene glycol (E1520). 07 % of the WHO recommended maximum daily intake of 2 g sodium for an adult”.