Dosing and uses of Banzel (rufinamide)
Adult dosage forms and strengths
tablet
- 200mg
- 400mg
oral suspension
- 40mg/mL
Lennox-Gastaut Syndrome
Indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome
Initial: 400-800 mg/day PO divided q12hr
Target dose: Increase daily dose by 400-800 mg every other day until a maximum of 3200 mg/day divided q12hr is reached
Unknown whether dose lower than the target dose is effective
Dosage modifications
Hemodialysis: Systemic exposure may be reduced to a limited (~30%); consider adjusting dose during the dialysis process
Hepatic impairment: Not studied; therefore, not recommended with severe hepatic impairment
Coadministration with valproate: Initiate at a dose lower dose (ie, <400 mg/day)
Pediatric dosage forms and strengths
tablet
- 200mg
- 400mg
oral suspension
- 40mg/mL
Lennox-Gastaut Syndrome
Indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome
<1 year: Safety and efficacy not established
≥1 year
- Initial: 10 mg/kg/day PO divided q12hr
- Target dose: Increase by ~10 mg/kg every other day until maximum of 45 mg/kg/day divided q12hr reached; not to exceed 3200 mg/day
- Unknown whether dose lower than target dose is effective
Dosage modifications
Hemodialysis: Systemic exposure may be reduced to a limited (~30%); consider adjusting dose during the dialysis process
Hepatic impairment: Not studied; therefore, not recommended with severe hepatic impairment
Coadministration with valproate: Initiate at a dose lower dose (ie, <10 mg/kg/day)
Banzel (rufinamide) adverse (side) effects
Frequency not defined
Diplopia
Dizziness
Fatigue
Headache
Somnolence
Nausea
Vomiting
Postmarketing reports
Steven's-Johnson syndrome
Warnings
Contraindications
Documented hypersensitivity
Familial Short QT syndrome
Cautions
Shortens QT intervaL
Not recommended in severe hepatic impairment
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, reported in patients taking antiepileptic drugs, including rufinamide; DRESS may be fatal or life-threatening; if DRESS suspected, evaluate patient immediately; discontinue therapy and initiate alternative treatment
Withdraw gradually
May impair ability to drive or perform hazardous tasks
May render hormonal contraceptives ineffective
Monitor for suicidal behavior
- (See FDA Warning on potential suicidal behavior)
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if excreted in breast milk; do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Banzel (rufinamide)
Mechanism of action
Modulates activity of sodium channels, prolonging their inactive state, which in turn limits repetitive firing of sodium-dependent action potentials and causing anticonvulsant effects
Pharmacokinetics
Bioavailability: 85%; increases by food
Half-Life: 6-10 hr
Vd: 50 L
Peak Plasma Time: 4-6 hr
Protein Bound: 34%
Enzymes induced: weak: CYP3A4
Enzymes Inhibited: weak: CYP2E1
Metabolism: hydrolysis of carboxamide group to inactive derivative
Excretion: Urine
Dialyzable: Yes (hemodialysis)
Administration
Instructions
Take with food
May crush tablet or cut in half
Measure and administer the oral suspension with the provided adapter and calibrated oral dosing syringe
Discontinuing drug
- Do not abruptly discontinue
- Reduce dose by 25% every 2 days to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus
