BANZEL (rufinamide) is a prescription medication approved for the adjunctive treatment of seizures associated with LGS in children 4 years and older and adults.

Parents and caregivers of children and adults with Lennox-Gastaut syndrome (LGS) may sometimes feel uncertain about the future. But good days can be measured in small ways.

Additional seizure control may be within reach

BANZEL, as add-on therapy, has been clinically proven to reduce seizures associated with LGS in children 4 years and older and adults. In a clinical study of children 4 years and older and adults with LGS, who were treated with BANZEL in addition to their existing medications, BANZEL:

• Reduced the frequency of tonic-atonic seizures (drop attacks)
  (a median* reduction of 42.5% in the frequency of this type of seizure versus a median increase of 1.4% in the placebo group)
• Reduced the frequency of total seizures
  (a median* reduction of 32.7% versus 11.7% for the placebo group)
• Reduced the severity of seizures
  (More parents or guardians of the BANZEL patients reported improvements in seizure severity than those in the placebo group—53.4% versus 30.6%)

*Median means that in a list of all the results from every person in the study, this number falls right in the middle, with an equal number of people who did better and people who did worse.

Patient safety and comfort are a primary concern. While BANZEL is an adjunctive therapy that may add powerful seizure control, there are risks. Please see the Important Safety Information below. We encourage you to talk to your healthcare provider about these risks.

In addition to delivering seizure control, BANZEL:

• Requires few dosing adjustments when used with other antiepileptic drugs (AEDs)
  
  
  BANZEL clearance was decreased by valproate. In children, valproate administration may elevate levels of rufinamide by up to 70%. Patients stabilized on BANZEL before being prescribed valproate should begin valproate therapy at a low dose, and titrate to a clinically effective dose. Similarly, patients on valproate should begin at a BANZEL dose lower than 10 mg/kg/day (children) or 400 mg/day (adults).
  
  

  a)	Predictions are based on BANZEL concentrations at the maximum recommended dose of BANZEL.
  b)	Maximum changes predicted to be in children and in patients who achieve significantly higher levels of BANZEL, as the effect of rufinamide on these antiepileptic drugs (AEDs) is concentration-dependent.
  c)	Larger effects in children at high doses/concentrations of antiepileptic drugs (AEDs).
  d)	Phenobarbital, primidone, and phenytoin were treated as a single covariate (phenobarbital-type inducers) to examine the effect of these agents on BANZEL clearance.
  e)	All compounds of the benzodiazepine class were pooled to examine for ‘class effect’ on BANZEL clearance.
  	Phenytoin: The decrease in clearance of phenytoin estimated at typical levels of rufinamide (Cavss 15 μg/mL) is predicted to increase plasma levels of phenytoin by 7% to 21%. As phenytoin is known to have non-linear pharmacokinetics (clearance becomes saturated at higher doses), it is possible that exposure will be greater than the model prediction.

Always follow the recommendations of your healthcare provider and follow dosing instructions exactly as prescribed.

Ask your healthcare provider about adding BANZEL to an existing treatment.

NEXT: Seizure Control