New Single Loading Dose Option For VIMPAT® (Lacosamide) In The EU Allows For Rapid Initiation Of Adjunctive Treatment Of Partial Onset Seizures

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New Single Loading Dose Option For VIMPAT® (Lacosamide) In The EU Allows For Rapid Initiation Of Adjunctive Treatment Of Partial Onset Seizures

Main Category: Epilepsy

Article Date: 06 Feb 2013

All formulations of VIMPAT® (lacosamide) approved in the European Union for initiation as a single loading dose (200 mg) followed by a daily maintenance dose regimen1

UCB announced this week that VIMPAT® (lacosamide) has been approved in the European Union for initiation as a single loading dose (200 mg), followed approximately 12 hours later by a 100 mg twice daily lacosamide maintenance dose regimen. The single loading dose option means that healthcare professionals in the European Union may choose between initiating adjunctive lacosamide treatment for adults with partial onset seizures using the standard dosing regimen, or alternatively using the single loading dose option when warranted.1

"As a leader in epilepsy, UCB is committed to delivering solutions aimed at improving the lives of people with epilepsy and advancing current standards of care. The single loading dose option is available for all formulations of lacosamide in the European Union and should help to fill an important treatment gap in adjunctive options for patients with partial onset seizures. It allows for the rapid attainment of lacosamide steady state plasma concentration in situations where it is deemed appropriate by the prescribing physician." said Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB.

"A single loading dose option allows for the rapid initiation of adjunctive lacosamide treatment for partial onset seizures in adults with epilepsy when required," said Dr. Fountain, Professor of Neurology and Director of the Comprehensive Epilepsy Program at the University of Virginia in Charlottesville, Virginia, USA. "The open-label intravenous study showed that rapid initiation of adjunctive lacosamide treatment was generally well tolerated by patients requiring a loading dose."

The single loading dose option is approved for all formulations of lacosamide - oral tablets, oral syrup and solution for infusion. A single loading dose should be administered under medical supervision in situations where rapid attainment of lacosamide steady state plasma concentration and therapeutic effect are warranted. Consideration should also be given to a potential increase in incidence of CNS adverse effects such as dizziness. Administration of a single loading dose has not been studied in acute conditions such as status epilepticus.1

In patients with mild or moderate renal impairment or mild to moderate hepatic impairment, a single loading dose of 200 mg may be considered, but further dose titration should be performed with caution. In patients with severe renal impairment and in patients with end stage renal disease, a maximum maintenance dose of 250 mg/day is recommended. In these patients, the dose titration should be performed with caution. If a single loading dose is indicated, an initial dose of 100 mg followed by a 50 mg twice daily regimen for the first week should be used. The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients.1

VIMPAT® was first launched in the European Union in September 2008, as adjunctive therapy for the treatment of partial onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy and is available as film-coated tablets, syrup and solution for infusion. VIMPAT® solution for infusion can be used to initiate lacosamide treatment and is also an alternative for patients when oral administration is temporarily not feasible.1

The most common adverse reactions occurring in 10 per cent or more of lacosamide-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.1 Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose.1 Additional important safety information for lacosamide is available below.1

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