LEVESINEAL

What it is

Levesineal is levetiracetam available in film-coated tablets in strengths of 250 mg, 500 mg, 750 mg and 1000 mg. The 250 mg tablets are blue and oval-shaped; the 500 mg tablets are yellow and oval-shaped; the 750 mg tablets are orange and oval-shaped; and the 1000 mg tablets are white and oval-shaped.

Approved indications Levesineal is indicated for:

— 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

For monotherapy, the recommended starting dose is 250 mg twice daily, increased to 500 mg twice daily after 2 weeks. The dose can be further increased by 250 mg twice daily every two weeks depending on clinical response, with a maximum dose of 1500 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. Depending on clinical response and tolerance, the daily dose can be increased up to 1500 mg twice daily, with dose changes made in 500 mg twice daily increments or decrements every 2 to 4 weeks. In children aged 4 to 11 years and adolescents aged 12–17 years 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 in two 30 mg/kg doses, with dose changes made in 10 mg/kg twice daily increments or decrements every two weeks.

Key safety warnings

Antiepileptic drugs, including Levesineal, 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. Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behaviour and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression; any unusual changes in mood or behaviour; or the emergence of suicidal thoughts, behaviour, or thoughts about self-harm. Behaviours of concern should be reported immediately to the treating doctor. Cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with Levesineal administration. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders. If Levesineal has to be discontinued, it is recommended to withdraw it gradually.

Contraindications

Levesineal is contraindicated in patients with hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients.

Regulatory history

Levesineal was first registered on the ARTG on 7 December 2018 with four registered variants: the 250 mg, 500 mg, 750 mg and 1000 mg film-coated tablet blister packs.