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Epilepsy Outreach NewsBANZEL (rufinamide) is now available for LGSJanuary 19, 2009 Eisai Corporation of North America is pleased to announce that BANZELTM (rufinamide) is now available in 200-mg and 400-mg scored tablets by medical prescription for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. BANZEL™ Background Information A double-blind, placebo-controlled pivotal study of LGS patients treated with BANZELTM as adjunctive therapy showed a 42.5 percent median reduction in frequency of drop attacks, seizures that cause a person to lose consciousness and fall to the ground, compared with a 1.4 percent median increase for placebo-treated patients. Drop attacks are a primary cause of injury in LGS patients. LGS is a disease that is devastating to the lives of patients and caregivers. Children usually experience the onset of LGS between the ages of 1 and 5 years old; approximately 3 to 7 percent of LGS patients die within a mean follow-up period of less than 10 years. The condition is difficult to treat, with patients often taking multiple antiepileptic drugs (AEDs) in attempts to control the seizures. The multiple types and frequency of seizures can lead to developmental delays, as well as behavioral disorders. Any questions please contact their Medical Services Department at 1-888-274-2378 or www.banzel.com.
BANZEL™ Important Safety Information Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. Use of BANZELTM (rufinamide) has been associated with central nervous system-related adverse reactions, such as somnolence or fatigue, coordination abnormalities, dizziness, gait disturbances, and ataxia. BANZELTM is contraindicated in patients with Familial Short QT syndrome. These patients should not be treated with BANZELTM. Caution should be used when administering BANZELTM with other drugs that shorten the QT interval. As with all AEDs, BANZELTM should be gradually withdrawn to minimize the risk of increased seizure frequency. Multi-organ hypersensitivity syndrome has been reported in association with BANZELTM therapy. In clinical trials, hypersensitivity reactions occurred mostly in the pediatric population and usually within four weeks of starting BANZELTM therapy. If this reaction is suspected, BANZELTM should be discontinued and alternative treatment started. All patients who develop a rash while taking BANZELTM must be closely supervised. In all patients with epilepsy treated with BANZELTM in double-blind, adjunctive therapy studies, the most commonly observed adverse reactions were headache, dizziness, fatigue, somnolence, and nausea. |
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Epilepsy affects up to 1% of the population, making it one of the most common neurological disorders. Genes and Disease by the National Center for Biotechnology |