LEVENAKAI

What it is

LEVENAKAI contains levetiracetam, available in tablet strengths of 250 mg, 500 mg and 1000 mg.

Approved indications

— Treatment of partial onset seizures with or without secondary generalisation in epileptic patients aged 4 years and older, initially as add-on therapy. — 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, increased to 500 mg twice daily after two weeks, with further increases of 250 mg twice daily every two weeks depending on 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 on 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 receiving add-on therapy, 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. Dose changes can be made in 10 mg/kg twice daily increments or decrements every two weeks.

Key safety warnings

Antiepileptic drugs, including LEVENAKAI, 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 any unusual changes in mood or behaviour. Pooled analyses of 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. LEVENAKAI may cause changes in behaviour such as aggression, agitation, anger, anxiety, apathy, depression, hostility and irritability, and psychotic symptoms. Patients treated with LEVENAKAI 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 in association with LEVENAKAI administration. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.

Contraindications

LEVENAKAI is contraindicated in patients with hypersensitivity to levetiracetam or other pyrrolidone derivatives. It is also contraindicated in patients with hypersensitivity to any excipients in LEVENAKAI tablets.

PBS listing

Information regarding PBS listing for LEVENAKAI is not contained in the provided source documents.

Regulatory history

LEVENAKAI levetiracetam tablets were first registered on the ARTG on 7 December 2018 in four strengths: 250 mg, 500 mg, 750 mg and 1000 mg.