KEPPRA

What it is

KEPPRA is levetiracetam, available as an oral solution (100 mg/mL) and as a concentrate solution for intravenous infusion (500 mg/5 mL).

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 as add-on therapy in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. — Primary generalised tonic-clonic seizures as add-on therapy 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, then 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 and increased up to 1500 mg twice daily depending on clinical response and tolerance, with dose changes made in 500 mg twice daily increments every 2 to 4 weeks. 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, with dose changes made in 10 mg/kg twice daily increments every two weeks. Dose adjustment is recommended in elderly patients with compromised renal function.

Key safety warnings

Antiepileptic drugs, including KEPPRA, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and any unusual changes in mood or behaviour. If KEPPRA has to be discontinued, it is recommended to withdraw it gradually. KEPPRA oral solution includes methylhydroxybenzoate and propylhydroxybenzoate which may cause allergic reactions (possibly delayed), and maltitol which may have a mild laxative effect. KEPPRA oral solution contains glycerol which can cause headache, stomach upset and diarrhoea when ingested in doses greater than 10 g. Patients with rare hereditary problems of fructose intolerance should not take the oral solution. KEPPRA concentrate solution for intravenous infusion should not be administered by rapid infusion or direct injection, and there is no data to support its use for status epilepticus. Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms at the beginning of treatment or following a dosage increase, and caution is recommended when performing skilled tasks such as driving vehicles or operating machinery.

Contraindications

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

PBS listing

Information on PBS listing is not available in the provided source documents.

Regulatory history

KEPPRA oral solution (100 mg/mL) was first listed on the Australian Register of Therapeutic Goods on 7 September 2006 under licence category RE.