LEVI

What it is

LEVI is levetiracetam, available as tablets containing 250 mg, 500 mg or 1000 mg of the active ingredient.

Approved indications

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

Dosing overview

The daily dose is administered in two equally divided doses. Dosing varies by indication and patient population.

For monotherapy: The recommended starting dose is 250 mg twice daily, which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon clinical response. The maximum dose is 1,500 mg twice daily. For add-on therapy in adults and adolescents weighing 50 kg or more: The therapeutic dose is 500 mg twice daily, which can be started on the first day of treatment. Depending upon clinical response and tolerance, the daily dose can be increased up to 1,500 mg twice daily. For children aged 4 to 11 years and adolescents weighing less than 50 kg: The initial therapeutic dose is 10 mg/kg twice daily. Depending on clinical response and tolerance, the daily dose can be increased up to 60 mg/kg daily.

Key safety warnings

Antiepileptic drugs, including levetiracetam, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients treated with any antiepileptic drug for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour and/or any unusual changes in mood or behaviour. Pooled analyses of 199 placebo-controlled clinical trials showed that patients randomised to one of the antiepileptic drugs had approximately twice the risk of suicidal thinking or behaviour compared to patients randomised to placebo, representing an increase of approximately one case of suicidal thinking or behaviour for every 530 patients treated. Levetiracetam may cause changes in behaviour such as aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability, and psychotic symptoms. Patients treated with levetiracetam should be monitored for psychiatric signs and symptoms. A paradoxical reaction of worsening of seizures may be observed, especially when starting treatment or at increase in dose. Cases of decreased blood cell counts including neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia have been described in association with levetiracetam administration. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.

Contraindications

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

PBS listing

No source information regarding PBS listing status is available in the provided documents.

Regulatory history

LEVI tablets (250 mg, 500 mg and 1000 mg) were first listed on the ARTG on 24 June 2011.