Banzel for Lennox-Gastaut Syndrome Seizure Treatment in Adults and Children

Banzel (rufinamide) is an oral antiepileptic medication approved as an add-on treatment for seizures associated with Lennox-Gastaut Syndrome (LGS) in patients aged 1 year and older, including both pediatric and adult populations. It is available as film-coated tablets and as an oral suspension, and is intended to be taken with food.

Banzel is used as adjunctive therapy to control seizures in patients diagnosed with Lennox-Gastaut Syndrome. It is approved for use in:

• Pediatric patients aged 1 year and older
• Adults (17 years and older)

This medication is not indicated for seizure types or conditions outside of LGS as supported by the prescribing information.

rufinamide

Banzel contains rufinamide, which modulates neuronal excitability by prolonging the inactive state of sodium channels in the brain. This action helps stabilize electrical activity and reduce the frequency of seizures associated with Lennox-Gastaut Syndrome.

Adults (17 years and older)

• Start with 400-800 mg per day, given in two divided doses with food
• Increase dose every other day by 400-800 mg until reaching a maximum of 3200 mg per day

Pediatric patients (1 year to less than 17 years)

• Start at approximately 10 mg/kg per day divided into two doses with food
• Increase dose every other day by about 10 mg/kg until a maximum of 45 mg/kg per day, not exceeding 3200 mg/day, divided into two doses

Administration

• Film-coated tablets may be taken whole, split in half, or crushed
• Oral suspension should be shaken well; use the provided adapter and calibrated syringe for accurate dosing

Special Populations and Adjustments

• Patients on valproate should start Banzel at a lower initial dose
• Use with caution in mild to moderate hepatic impairment; not recommended in severe hepatic impairment
• Hemodialysis can reduce Banzel exposure by about 30%, so dose adjustment may be needed during dialysis

Banzel is contraindicated in patients with Familial Short QT syndrome due to the increased risk of ventricular arrhythmias and sudden death.

Suicidal Thoughts and Behavior

Use of Banzel and other antiepileptic drugs carries an increased risk of suicidal ideation and behavior. Patients should be closely monitored for signs of depression, mood changes, or suicidal thoughts, especially during the first weeks of treatment.

Central Nervous System Effects

Banzel may cause somnolence, fatigue, dizziness, coordination problems, ataxia, and gait disturbances. Patients are advised not to drive or operate machinery until they understand how Banzel affects them.

QT Interval Shortening

Banzel can shorten the QT interval on the ECG, primarily at doses exceeding 2400 mg twice daily. While no clinical arrhythmias have been associated, it is contraindicated in patients with Familial Short QT syndrome, who are at increased risk of ventricular arrhythmias and sudden death. Caution is advised when combined with other QT-shortening drugs.

Multi-organ Hypersensitivity (DRESS)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported, mainly within the first 4 weeks of treatment, often presenting with fever, rash, lymphadenopathy, and organ involvement. Immediate discontinuation of Banzel is required if DRESS is suspected.

Withdrawal

Banzel should be tapered gradually to reduce the risk of seizure worsening or status epilepticus. A reduction of approximately 25% every 2 days has been used in clinical trials.

Status Epilepticus Risk

Episodes of status epilepticus have been reported more frequently in Banzel-treated patients than placebo, especially in Lennox-Gastaut Syndrome trials.

Leukopenia

Banzel can decrease white blood cell count; leukopenia occurred in 3.7% of treated patients compared to 1.2% on placebo.

Common side effects (≥10% incidence and more frequent than placebo)

• Headache
• Dizziness
• Fatigue
• Somnolence
• Nausea

Other adverse reactions reported in pediatric patients (3% or more incidence than placebo)

• Somnolence
• Vomiting
• Headache
• Fatigue
• Dizziness
• Nausea
• Influenza
• Nasopharyngitis
• Decreased appetite
• Rash
• Ataxia
• Diplopia
• Bronchitis
• Sinusitis
• Psychomotor hyperactivity
• Upper abdominal pain
• Aggression
• Ear infection
• Disturbance in attention
• Pruritis

Other adverse reactions in adults (≥3% and greater than placebo)

• Diplopia
• Vision blurred
• Tremor

Coadministration with valproate requires initiation of Banzel at a lower dose due to potential drug interactions affecting metabolism. Use caution when combining Banzel with other drugs that shorten the QT interval because of additive effects on cardiac repolarization.

Specific storage instructions are not detailed in the supplied evidence.