Usual Adult Dose for Lennox-Gastaut Syndrome

Initial dose: 400 to 800 mg orally per day in 2 equally divided doses

• Titrate in 400 to 800 mg increments every other day until a maximum daily dose of 3200 mg/day is reached

Maintenance dose: 1600 mg orally twice a day

Comments:

• It is not known if doses lower than 3200 mg/day are effective.
• For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.

Usual Pediatric Dose for Lennox-Gastaut Syndrome

1 year of age or older:
Initial dose: 10 mg/kg/day orally in 2 equally divided doses

• Titrate in 10 mg/kg increments every other day to a target dose of 45 mg/kg/day

Maintenance dose: 45 mg/kg orally per day in 2 equally divided doses
Maximum dose: 3200 mg/day

Comments:

• It is not known if doses lower than 45 mg/kg (not to exceed 3200 mg/day) are effective.
• For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild to moderate hepatic impairment: Caution recommended
Severe hepatic impairment: Use not recommended

Dose Adjustments

Concomitant Administration of Valproate:

• For patients stabilized on rufinamide before initiating valproate: Initiate valproate at lower doses
• For patients stabilized on valproate before beginning rufinamide:
• Adults: Initial dose 400 mg orally per day
• Pediatrics: Initial dose 10 mg/kg/day

Withdrawal of antiepileptic drugs (AEDs):

• This drug should be withdrawn gradually to minimize risk of precipitating seizure, seizure exacerbation, or status epilepticus
• If abrupt discontinuation is medically necessary, the transition to another AED should be made under close medical supervision
• In clinical trials, discontinuation was achieved by reducing the dose by approximately 25% every 2 days.

Precautions

CONTRAINDICATIONS:

• In patients with Familial Short QT syndrome

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis may reduce plasma levels by about 30%; dose adjustments should be considered

Other Comments

Administration advice:

• Take orally with food
• May administer tablets whole, cut in half, or crushed
• Oral suspension: Shake well (vigorously) before every administration; measure dose using the enclosed bottle adapter and dosing syringe

Storage requirements:

• Oral tablets and suspension: Store at room temperature (59F to 86F [15C to 30C])
• Oral Suspension: Replace cap securely after opening; store in an upright position; use within 90 days of first opening the bottle

General:

• The oral suspension does not contain lactose or gluten and is dye-free.
• The oral tablets and oral suspension have been shown to be bioequivalent; patients should be monitored during the switch over period.

Monitoring:

• Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Patients/caregivers should understand that this drug may cause central nervous system adverse reactions such as somnolence, dizziness and coordination difficulties; patients should not drive or perform hazardous tasks until they have gained sufficient experience with this drug.
• Patients should understand that alcohol may cause additive central nervous system effects.
• Patients should be instructed to contact their healthcare provider if they experience a rash associated with a fever.
• Women of childbearing potential should be instructed on contraceptive use and instructed to notify their healthcare provider if they become pregnant or intend to become pregnant.

Frequently asked questions

• What is the mechanism of action of Banzel (rufinamide)?