Product Dossier
VIMCOSA
Product Dossier for VIMCOSA (lacosamide, Pharmacor). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Pharmacor
- Active ingredient: lacosamide
- Therapeutic area: Neurology
- Related brand: VIMPAT
- Related brand: LACOSAM
- Related brand: LACOSACOR
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
VIMCOSA is lacosamide film-coated tablets 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
VIMCOSA film-coated tablets may be taken with or without food. The film-coated tablets must not be divided. Conversion to or from oral and intravenous administration can be done directly without titration, with the total daily dose and twice daily administration maintained. If VIMCOSA 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 source documents do not contain sufficient information about key safety warnings to include in this dossier.
Contraindications
The source documents do not contain information about contraindications.
PBS listing
VIMCOSA 150 mg tablets are listed on the PBS with 2 items under a streamlined restriction at an ex-manufacturer price of A$17.12.
Regulatory history
VIMCOSA lacosamide tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg were first registered on the ARTG on 8 February 2022.