Product Dossier

LACOSACOR

Product Dossier for LACOSACOR (lacosamide, Pharmacor). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

LACOSACOR is a lacosamide film-coated tablet medicine available in strengths of 50 mg, 100 mg, 150 mg and 200 mg.

Approved indications —

Monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. — Add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. — Add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

Dosing overview

LACOSACOR film-coated tablets may be taken with or without food. The film-coated tablets must not be divided. Conversion to or from oral and IV administration can be done directly without titration, with the total daily dose and twice daily administration maintained. If LACOSACOR has to be discontinued, it is recommended this be done gradually, for example by tapering the daily dose by 200 mg per week.

Key safety warnings

The provided documents do not contain information about key safety warnings for LACOSACOR.

Contraindications

The provided documents do not contain information about contraindications for LACOSACOR.

PBS listing

The provided documents do not contain information about PBS listing for LACOSACOR.

Regulatory history

LACOSACOR was first registered on the ARTG on 8 February 2022 across eight entries covering 50 mg, 100 mg, 150 mg and 200 mg strengths in both tablet bottle and blister pack formats.