INDICATION
VIMPAT® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
IMPORTANT SAFETY INFORMATION
VIMPAT is associated with important warnings and precautions including suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity.
Partial-Onset Seizures
In the adult adjunctive placebo-controlled trials for partial-onset seizures, the most common
adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia.
In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed
and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia
(observed at a higher rate of ≥2%). Pediatric adverse reactions were similar to those seen in adult
patients.
Primary Generalized Tonic-Clonic Seizures
In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the
adverse reactions were generally similar to those that occurred in the partial-onset seizures trials.
The adverse reactions most commonly reported were dizziness, somnolence, headache, and
nausea.
VIMPAT is a Schedule V controlled substance.
VIMPAT® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
VIMPAT has proven efficacy in children through extrapolation of adult data and a placebo-controlled adjunctive therapy trial for partial-onset seizures.1,2
- The pediatric indication for VIMPAT is based on the principle of extrapolation of efficacy data from adults and is supported by safety and pharmacokinetics data collected in children1
- The efficacy of VIMPAT in pediatric patients 4 years of age and older with partial-onset seizures was confirmed in a placebo-controlled pediatric trial2
VIMPAT offers an established safety and tolerability profile.1,2
- Adverse reactions in pediatric patients were similar to those seen in adult patients. The most common adverse reactions in adults are dizziness, headache, nausea and diplopia
- Pediatric tolerability was demonstrated for partial-onset seizures in open-label trials and a placebo-controlled trial
VIMPAT is available for children in oral solution and tablets with 1:1 dose conversion to meet your patients' needs.2VIMPAT injection may be used for children with primary generalized tonic-clonic seizures when oral administration is temporarily not feasible. VIMPAT can be administered intravenously with the same dosing regimens described for oral dosing. The use of a loading dose in children has not been studied.
VIMPAT is covered by most commercial and Medicaid plans, because accessibility and affordability matter.
- >95% of commercial and Medicaid patients have formulary access to VIMPAT1
- Nearly 75% of eligible commercially insured patients paid $20 or less per 30-day supply of VIMPAT with the VIMPAT Savings Program1
References
- Data on file. UCB, Inc.
- VIMPAT® (lacosamide): US prescribing information. Smyrna (GA): UCB, Inc.