LEVECEUMID

What it is

LEVECEUMID contains levetiracetam as the active ingredient, available in 250 mg, 500 mg and 1000 mg tablets. The tablets are film-coated and capsule shaped, with the 250 mg strength presented as light blue, the 500 mg as yellow, and the 1000 mg as white.

Approved indications

— Add-on therapy in patients aged 4 years and older for the treatment of partial onset seizures with or without secondary generalisation. — Monotherapy in patients from 16 years of age with newly diagnosed epilepsy for the treatment of partial onset seizures with or without secondary generalisation. — Add-on therapy in adults and adolescents from 12 years of age for the treatment of myoclonic seizures in juvenile myoclonic epilepsy. — Add-on therapy in adults and children from 4 years of age for the treatment of primary generalised tonic-clonic seizures in idiopathic generalised epilepsy.

Dosing overview

LEVECEUMID tablets are taken orally with liquid, with or without food. The daily dose is administered in two equally divided doses. For monotherapy, the recommended starting dose is 250 mg twice daily, increased to 500 mg twice daily after two weeks, with further increases of 250 mg twice daily every two weeks depending on clinical response, to a maximum dose of 1,500 mg twice daily. For add-on therapy in adults and adolescents aged 12 years and older weighing 50 kg or more, the therapeutic dose is 500 mg twice daily, which can be started on the first day of treatment, with increases up to 1,500 mg twice daily depending on clinical response and tolerance. For children aged 4 to 11 years and adolescents weighing less than 50 kg, the initial therapeutic dose is 10 mg/kg twice daily, with increases up to 60 mg/kg daily in two 30 mg/kg doses, made in 10 mg/kg twice daily increments every two weeks.

Key safety warnings

Antiepileptic drugs, including LEVECEUMID, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication, and patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour and any unusual changes in mood or behaviour. Pooled analyses of clinical trials showed patients randomised to antiepileptic drugs had approximately twice the risk of suicidal thinking or behaviour compared to placebo, with an estimated incidence of 0.43% among drug-treated patients compared to 0.24% among placebo-treated patients. LEVECEUMID may cause changes in behaviour such as aggression, agitation, anger, anxiety, apathy, depression, hostility and irritability, as well as psychotic symptoms, and patients should be monitored for psychiatric signs and symptoms. A paradoxical reaction of worsening of seizure may be observed especially when starting treatment or at increase in dose; lack of efficacy or seizure worsening has been reported in patients with epilepsy associated with SCN8A mutations. Cases of decreased blood cell counts including neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia have been described, and complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.

Contraindications

LEVECEUMID is contraindicated in patients with hypersensitivity to levetiracetam, other pyrrolidone derivatives, or any other excipients in the tablets.

Regulatory history

LEVECEUMID levetiracetam tablets were first listed on the ARTG on 2018-12-07 in four strengths: 250 mg, 500 mg, 750 mg and 1000 mg film-coated tablets, all under licence category RE.