LEVETIRACETAM-WGR

What it is

LEVETIRACETAM-WGR contains levetiracetam as the active ingredient, available in 250 mg, 500 mg and 1000 mg tablet strengths. The tablets are film-coated: 250 mg tablets are light blue capsule-shaped; 500 mg tablets are yellow capsule-shaped; and 1000 mg tablets are white capsule-shaped.

Approved indications —

Partial onset seizures with or without secondary generalisation in epileptic patients aged 4 years and older, initially as add-on therapy. — Partial onset seizures with or without secondary generalisation as monotherapy in patients from 16 years of age with newly diagnosed epilepsy. — Myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy, as add-on therapy. — Primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy, as add-on therapy.

Dosing overview

The daily dose is administered in two equally divided doses. Dosing varies by indication, age, weight and renal function. 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, up to a maximum dose of 1500 mg twice daily. For add-on therapy in adults and adolescents aged 12 years or older weighing 50 kg or more, the therapeutic dose is 500 mg twice daily, which can be started on the first day of treatment and increased up to 1500 mg twice daily in 500 mg increments every two to four weeks depending on clinical response and tolerance. 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, which can be increased up to 60 mg/kg daily in two divided doses, with changes made in 10 mg/kg increments every two weeks. Patients with renal impairment require dose individualisation according to renal function, with specific dosing schedules based on creatinine clearance.

Key safety warnings

Antiepileptic drugs, including levetiracetam, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication, and patients treated with any antiepileptic drug should be monitored for emergence or worsening of depression, suicidal thoughts or behaviour and unusual changes in mood or behaviour. Pooled analyses of 199 placebo-controlled clinical trials showed that patients randomised to an antiepileptic drug had approximately twice the risk of suicidal thinking or behaviour compared to placebo-treated patients, with an estimated incidence of 0.43% among drug-treated patients versus 0.24% among placebo-treated patients. Levetiracetam may cause changes in behaviour including aggression, agitation, anger, anxiety, apathy, depression, hostility and irritability, as well as psychotic symptoms, and 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 dose increase, and 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 levetiracetam administration, and complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.

Contraindications

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

PBS listing

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

Regulatory history

LEVETIRACETAM-WGR was first listed on the ARTG on 30 May 2024, with three variants registered: 250 mg film-coated tablets (ARTG 437370), 500 mg film-coated tablets (ARTG 437371), and 1000 mg film-coated tablets (ARTG 437372), all under licence category RE.