Product Dossier
LACOSAM
Product Dossier for LACOSAM (lacosamide, Accord Healthcare). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Accord Healthcare
- Active ingredient: lacosamide
- Therapeutic area: Neurology
- Related brand: VIMCOSA
- Related brand: VIMPAT
- Related brand: LACOSACOR
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
LACOSAM is lacosamide, available as film-coated tablets 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
LACOSAM tablets may be taken with or without food. If LACOSAM has to be discontinued, it is recommended this be done gradually, for example by tapering the daily dose by 200 mg per week.
Regulatory history
LACOSAM was first registered on the ARTG on 29 May 2019, with all four strengths (50 mg, 100 mg, 150 mg and 200 mg film-coated tablets) listed on the same date under licence category RE.