LEVEFINTAIC

What it is

LEVEFINTAIC is a levetiracetam tablet product supplied in 250 mg, 500 mg and 1000 mg strengths.

Approved indications

— Use in epileptic patients aged 4 years and older, initially as add-on therapy, 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. 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 the clinical response. The maximum dose is 1,500 mg twice daily. For add-on therapy in adults and adolescents aged 12 to 17 years 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 the 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 aged 12 to 17 years weighing less than 50 kg, the initial therapeutic dose is 10 mg/kg twice daily. Depending on the clinical response and tolerance, the daily dose can be increased up to 60 mg/kg daily.

Key safety warnings

**Suicidal thoughts and behaviour.** 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. **Psychiatric reactions and behaviour changes.** 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. **Seizure worsening.** A paradoxical reaction of worsening of seizure may be observed especially when starting treatment or at increase in dose. **Blood cell count changes.** Cases of decreased blood cell counts (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

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

PBS listing

Information on PBS listing status, strength, item count, restriction type and ex-manufacturer price is not available in the provided source documents.

Regulatory history

LEVEFINTAIC levetiracetam was first listed on the ARTG on 7 December 2018, with registrations for 250 mg, 500 mg, 750 mg and 1000 mg film-coated tablet strengths under licence category RE.