Section 01 · Monograph

Rufinamide

Reviewed Nov 2026FDA label

BanzelNa+ channel modulator

Indications

Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 year of age and olderFDA-labeled

Triazole derivative that modulates sodium channel activity, primarily by prolonging the inactive state of the channel, limiting sustained repetitive neuronal firing

Adults (≥17 years): initiate 400-800mg/day in 2 divided doses; increase by 400-800mg every other day to a maximum of 3200mg/day
Administer with food; tablets may be taken whole, halved, or crushed; oral suspension also available
Use lower starting doses and slower titration in patients also taking valproate (see interactions)
Taper gradually on discontinuation to reduce risk of seizure exacerbation or status epilepticus

Pediatric (1-17 years): initiate approximately 10mg/kg/day in 2 divided doses; increase by ~10mg/kg/day every other day to a target of 45mg/kg/day or 3200mg/day, whichever is lower

Valproate inhibits rufinamide metabolism and can substantially increase rufinamide levels (more pronounced in children) — use lower starting/maintenance doses when combined
Enzyme-inducing AEDs (carbamazepine, phenytoin, phenobarbital, primidone) decrease rufinamide clearance
Rufinamide modestly decreases carbamazepine and lamotrigine concentrations via CYP3A4 induction
Induces CYP3A4, reducing exposure to hormonal contraceptives (ethinyl estradiol/norethindrone) — additional non-hormonal contraception recommended
Use caution with other QT-shortening drugs given rufinamide's own QT-shortening effect

Common (≥10%): headache, dizziness, fatigue, somnolence, nausea, diplopia, vomiting
QT interval shortening (dose-related; mean approximately 20msec at typical doses)
Multi-organ hypersensitivity reaction (DRESS) — more common in children, typically within the first 4 weeks; presents with fever, rash, lymphadenopathy, and organ involvement
Leukopenia; Stevens-Johnson syndrome reported postmarketing
Can worsen seizure control or precipitate status epilepticus in some patients, and may exacerbate certain generalized seizure types
Suicidal ideation/behavior (class effect of AEDs)

Consider baseline/periodic ECG in patients with cardiac conduction concerns or those on other QT-shortening drugs, given the contraindication in Familial Short QT syndrome
Monitor for signs of multi-organ hypersensitivity (fever, rash, lymphadenopathy), especially during the first weeks of therapy
Monitor for emerging suicidal ideation or mood changes
Watch for worsening seizure frequency or new seizure types, particularly in patients with generalized seizure disorders

Animal studies showed developmental toxicity (skeletal abnormalities, reduced fetal weight) at clinically relevant exposures; human data limited. NAAED Pregnancy Registry enrollment encouraged (1-888-233-2334)
No data on presence in human milk or effects on the breastfed infant; weigh risks/benefits