Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Approves Oral Option for Pediatric Epilepsy
UCB news release; 2017 Nov 6
UCB recently announced that the US Food and Drug Administration (FDA) has approved a label extension for the company's anti-epileptic drug (AED) Vimpat (lacosamide) CV as an oral option for the treatment of partial-onset seizures (POS) in pediatric patients aged ≥4 years. UCB is headquartered in Atlanta, GA, and Brussels, Belgium.
Indications: This new approval provides clinicians with the option to prescribe Vimpat to their pediatric patients either as an oral solution or a convenient tablet, allowing for flexible administration options, an important consideration when treating children.
Dosage/administration: For pediatric patients from 4 years to <17 years, the recommended dosage is based on body weight and is administered orally twice daily. Increased dosage is based on clinical response and tolerability, and no more frequently than once per week is recommended.
Adverse reactions: Adverse reactions in pediatric patients are similar those of adult patients: diplopia, headache, dizziness, and nausea.
UCB's VIMPAT® (lacosamide) now approved by FDA to treat partial-onset seizures in pediatric epilepsy patients. [news release]. Atlanta, GA, and Brussels, Belgium: UCB. November 6, 2017. https://www.prnewswire.com/news-releases/ucbs-vimpat-lacosamide-now-approved-by-fda-to-treat-partial-onset-seizures-in-pediatric-epilepsy-patients-300549924.html. Accessed November 9, 2017.