Rufinamide
BANZEL
Pronunciation: roo-FIN-a-mide (ban-ZEL)
“Ruffin’ Band”
The logo on the drum is the retired “Roughin’ Ban” mascot
Pronounced rue FIN a mide – think “Roofin’ Band”
What it isSodium-channel blocker prolonging inactivation; seizures associated with Lennox-Gastaut syndrome.
Why this oneIt specifically reduces drop attacks, the seizure type most likely to cause traumatic injury in this syndrome.
What limits itQT shortening can be hazardous in short-QT syndromes; take with food, and valproate can substantially raise exposure.
FDA-approved for
- Lennox-Gastaut syndrome (2008)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Lennox-Gastaut syndrome (adjunctive) | Pediatric 1–<17 yr | 10 mg/kg/day in 2 divided doses | — | 45 mg/kg/day (<=3200 mg/day) BID |
| Lennox-Gastaut syndrome (adjunctive) | Adults >=17 yr | 400–800 mg/day in 2 divided doses | — | 3200 mg/day BID |
Titration Increase every other day (by ~10 mg/kg/day in children; by 400–800 mg/day in adults).
Renal Hemodialysis reduces exposure ~30%; consider dose adjustment around dialysis. No specific adjustment otherwise.
Hepatic Not studied; not recommended in severe impairment; use caution in mild-moderate impairment.
Instructions
- Take with food
- Tablets may be given whole, halved, or crushed
- Withdraw gradually to reduce risk of increased seizures
- Patients on valproate: start below 10 mg/kg/day (children) or 400 mg/day (adults)
Available strengths
- tab 100, 200, 400 mg
- susp 40 mg/mL
Contraindications
- Familial Short QT syndrome
Cautions
- Suicidal thoughts / behavior
- CNS reactions (somnolence, dizziness, coordination abnormalities)
- QT shortening — caution with other QT-shortening drugs
- Multi-organ hypersensitivity (DRESS) — discontinue
- Withdraw gradually to avoid increased seizures / status epilepticus
Adverse reactions
- Headache
- Dizziness
- Fatigue
- Somnolence
- Nausea
Pregnancy Pregnancy exposure registry available; encourage enrollment of patients exposed during pregnancy.
Lactation Undefined
Cost
Generic entry2016
NO BOXED WARNINGS
Principal riskQT shortening; valproate raises levels
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilitySedation, dizziness and agent-specific rash, behavioral, hepatic, hematologic or teratogenic toxicity.
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