Product Details

Banzel

Rufinamide
100 mg
Tablet


DIN/PIN/NPN

02369613

Manufacturer

Eisai Limited

Formulary Listing Date

2023-04-28  

Unit Price

0.8730

Amount MOH Pays

0.8730

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

N03AF03

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anticonvulsants

Rufinamide

  • Brand(s): Banzel
  • Dosage Form/Strength: 100 mg, 200 mg, 400 mg

For the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients who meet the following criteria:

  • Patient is 4 years of age or older; AND

  • the Patient is currently on two or more anti-epileptic drugs (AEDs) without optimal seizure control; AND

  • the Patient has failed an adequate trial1 of lamotrigine AND topiramate; AND

  • the Patient is in the care of a physician experienced in managing seizures.

1If an adequate trial of lamotrigine and/or topiramate is not possible due to intolerance or contraindication, a less costly AED that is listed as a benefit on the Ontario drug benefit formulary must be tried in its place

Dose: Maximum daily dose is 1,300 mg per day for patients less than 30 kg; and 3,200 mg per day for patients 30 kg or greater

Exclusion Criteria:

Funding will not be approved for the following circumstances:

  • Banzel used first line for LGS; OR

  • Treatment of partial seizures

Duration of Approval: Lifetime

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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