BANZEL

Overview BANZEL oral suspension is bioequivalent on a mg per mg basis to BANZEL tablets. BANZEL is well absorbed after oral administration. However, the rate of absorption is relatively slow and the extent of absorption is decreased as dose is increased. The pharmacokinetics does not change with multiple dosing. Most elimination of rufinamide is via metabolism, with the primary metabolite resulting from enzymatic hydrolysis of the carboxamide moiety to form the carboxylic acid. This metabolic ro...

Adult and Pediatric Patients ages 4 years and older The effectiveness of BANZEL as adjunctive treatment for the seizures associated with Lennox-Gastaut Syndrome (LGS) in adult and pediatric patients ages 4 years and older was established in a single multicenter, double-blind, placebo-controlled, randomized, parallel-group study (N=138). Male and female patients (between 4 and 30 years of age) were included if they had a diagnosis of inadequately controlled seizures associated with LGS (including both atypical absence seizures and drop attacks) and were being treated with 1 to 3 concomitant sta...

The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] Central Nervous System Reactions [see Warnings and Precautions ( 5.2 )] QT Shortening [see Warnings and Precautions ( 5.3 )] Multi-Organ Hypersensitivity/Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions ( 5.4 )] Leukopenia [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥ 1...

BANZEL is contraindicated in patients with Familial Short QT syndrome [see Warnings and Precautions ( 5.3 ) ] . BANZEL is contraindicated in patients with Familial Short QT syndrome ( 4 )

Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior ( 5.1 ) Central nervous system reactions can occur ( 5.2 ) Use caution when administering BANZEL with other drugs that shorten the QT interval ( 5.3 ) Discontinue BANZEL if multi-organ hypersensitivity reaction occurs ( 5.4 ) Withdraw BANZEL gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus ( 5.5 ) 5.1 Suicidal Behavior and Idea...

7 D RUG INTERACTION S Patients on valproate should begin at a BANZEL dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults) ( 7.2 ) Hormonal contraceptives may be less effective with BANZEL; use additional non-hormonal forms of contraception ( 7.3 ) 7.1 Effects of BANZEL on other AEDs Population pharmacokinetic analysis of average concentration at steady state of carbamaz...