Product Dossier
VIMPAT
Product Dossier for VIMPAT (lacosamide, UCB). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: UCB
- Active ingredient: lacosamide
- Therapeutic area: Neurology
- Related brand: VIMCOSA
- Related brand: LACOSAM
- Related brand: LACOSACOR
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
Vimpat is lacosamide, available as film-coated tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg. Vimpat oral solution is available as 10 mg/mL strength.
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
Vimpat therapy can be initiated with either oral or IV administration. The oral solution may be diluted in a glass of water, and both the film-coated tablets and oral solution 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. If Vimpat has to be discontinued, it is recommended this be done gradually, for example by tapering the daily dose by 200 mg/week.
PBS listing
The oral solution 10 mg per mL (200 mL bottle) is listed on the PBS with 4 items. Restriction type is streamlined, with an ex-manufacturer price of A$51.71.
Regulatory history
Vimpat lacosamide 200 mg/20 mL injection vial was first listed on the ARTG on 2009-07-20. Film-coated tablets in 50 mg, 100 mg, 150 mg and 200 mg strengths were first listed on the ARTG on 2012-07-31. The TGA approved an application for Vimpat on 24 July 2018 that extended the drug's approved uses to include monotherapy and add-on therapy for partial seizures in patients aged 4 years and older, and registered a new 10 mg/mL oral solution. The oral solution was first listed on the ARTG on 2018-08-14. In November 2018, the PBAC recommended extensions to the existing Authority Required (Streamlined) listing for partial epileptic seizures in patients aged 4 to 15 years and for intractable partial epileptic seizures in combination with two or more anti-epileptic drugs, as well as a new listing for the oral liquid formulation. In March 2021, the PBAC recommended a new indication for epilepsy in idiopathic generalised epilepsy with primary generalised tonic-clonic seizures.