Abstracts

Rationale: Rufinamide was released by the FDA in January 2009 for use as adjunctive treatment for seizures in patients age 4 years and older with Lennox Gastaut Syndrome (LGS). Use of Banzel in other epilepsy types and syndromes is limited. We report our clinical experience with the use of Banzel in patients with refractory tonic, tonic-clonic, atonic, atypical absence, infantile spasms (IS) and complex partial seizures. The most common side effects of Banzel noted in studies included somnolence (17%), vomiting (17%), headache (16%), fatigue (9%), nausea (7%). To initiate treatment, it is recommended to start Banzel at 10mg/kg/day and titrate up by this amount every other day until reaching a dose of 45mg/kg/day. In an attempt to minimize side effects in our patients we opted to start dosing at 5mg/kg/day and increase by the same dose every 5 days to a maximum of 50mg/kg/day until reaching efficacy or difficulty with tolerability. Methods: We conducted a retrospective study of patients followed through the MGH Pediatric Epilepsy Program and Herscot Center for Tuberous Sclerosis Complex (TSC) who were started on Banzel between January and May 2009. Demographics included age, sex, seizure etiology, seizure type, seizure frequency prior to and after Banzel treatment, concurrent and prior treatments, and any side effects of Banzel treatment. Results: We identified 37 patients who were started on Banzel, including 19 males and 18 females. Ages ranged between 3 to 37 years (average age 12 years). The majority had partial onset epilepsy; several had mixed seizure disorders; several had generalized epilepsies including two with juvenile myoclonic epilepsy. Three had LGS and two had IS. Etiologies varied and included TSC, Angelman syndrome, Rett syndrome, lissencephaly, previous meningitis and perinatal stroke as well as idiopathic epilepsy. Approximately 30% of the patients started on Banzel experienced a significant decrease in both the severity and number of seizures, including 3 who became seizure free at low therapeutic doses; one patient also had a marked reduction in infantile spasms two patients experienced an exacerbation of myoclonic seizures. Several of the reported side effects of Banzel including vomiting, headache or rash were not seen in our population. One patient complained of nausea and dizziness and one patient noted blurred vision (4% in clinical trials); both occurred in adolescent females at doses > 2400mg/day. Fatigue was noted in 4 patients. Conclusions: In our experience of patients with refractory epilepsy, varying in type and etiology, Banzel appeared to be effective in providing improved seizure control in at least 1/3, including one patient with IS. It also appeared to be very well tolerated with minimal side effects noted. Initiating treatment at lower doses and increasing at a slower rate may help to prevent side effects of nausea, vomiting, headache and dizziness, although it did not prevent fatigue. It is possible that the fatigue may, in part, be due to concomitant medications, and possible drug-drug interactions should be considered.