VIMPAT Film-coated tablet, Treatment initiation pack Ref.[8021] Active ingredients: Lacosamide

Posology

The physician should prescribe the most appropriate formulation and strength according to weight and dose.

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

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.

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).

Vimpat treatment initiation pack contains 4 different packages (one for each tablet strength) with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient’s response and tolerability. The packages are marked with ‘week 1 (2, 3 or 4)’.

On the first day of treatment the patient starts with Vimpat 50 mg tablets twice a day (100 mg/day).

During the second week, the patient takes Vimpat 100 mg tablets twice a day (200 mg/day).

Depending on response and tolerability, Vimpat 150 mg tablets may be taken twice a day (300 mg/day) during the third week and Vimpat 200 mg tablets twice a day (400 mg/day) during the fourth week.

Discontinuation

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.

Special populations

Elderly (over 65 years of age)

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).

Renal impairment

No dose adjustment is necessary in mildly and moderately renally impaired adult and paediatric patients (CL_CR >30 ml/min). A maximum dose of 250 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with severe renal impairment (CL_CR ≤30 ml/min) or with end-stage renal disease. In paediatric patients weighing less than 50 kg with severe renal impairment (CL_CR ≤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). In all patients with renal impairment, the dose titration should be performed with caution (see section 5.2).

Hepatic impairment

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.

Paediatric population

Adolescents and children weighing 50 kg or more

Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above).

Children (from 2 years of age) and adolescents weighing below 50 kg

This presentation is not suitable for this category of patients.

Children less than 2 years of age

The safety and efficacy of lacosamide in children aged below 2 years have not yet been established. No data are available.

Method of administration

Lacosamide film-coated tablets are for oral use. Lacosamide may be taken with or without food.

Symptoms

Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.

• The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 800 mg were not clinically different from those of patients administered recommended doses of lacosamide.
• Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, seizures (generalised tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, shock and coma have also been observed. Fatalities have been reported in patients following an intake of acute single overdose of several grams of lacosamide.

Management

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).

5 years.

This medicinal product does not require any special storage conditions.

PVC/PVDC blister sealed with an aluminium foil.

The treatment initiation pack contains 4 cartons, each carton with 14 Vimpat film-coated tablets of 50 mg, 100 mg, 150 mg and 200 mg.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.