• Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

Contraindicated in:

• Hypersensitivity
• Familial short QT syndrome
• Severe hepatic impairment.

Use Cautiously in:

• All patients (may ↑ risk of suicidal thoughts/behaviors)
• Mild to moderate hepatic impairment
• OB: Safety in pregnancy not established
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Rep: Women of reproductive potential (may ↓ effectiveness of hormonal contraceptives)
• Pedi: Children <1 yr (safety and effectiveness not established); children <12 yr (↑ risk of drug reaction with eosinophilia and systemic symptoms [DRESS]).

CV: QT interval prolongation.

Derm: DRESS, rash, STEVENS-JOHNSON SYNDROME (SJS).

EENT: diplopia.

GI: nausea, changes in appetite.

GU: urinary frequency.

Hemat: anemia.

Neuro: dizziness, fatigue, headache, somnolence, ataxia, coordination abnormalities, gait disturbances, SUICIDAL THOUGHTS.

Misc: hypersensitivity reactions (↑ in children).

Drug-Drug:

• Potent inducers of the CYP450 enzyme, including carbamazepine, phenytoin, primidone, and phenobarbital, may ↓ levels and effectiveness.
• Valproatemay ↑ levels and the risk of toxicity; valproate should be started at a low dose in patients stabilized on rufinamide. In patients stabilized on valproate, rufinamide should be started at a low dose.
• May ↓ levels and effectiveness of hormonal contraceptives.
• May ↑ levels and the risk of toxicity of phenytoin.

(Generic available)

• Tablets: 100 mg; 200 mg; 400 mg;
• Oral suspension (orange flavor): 40 mg/mL;

• PO (Adults): 400–800 mg/day in two divided doses; ↑ by 400–800 mg/day every 2 days until a maximum daily dose of 3200 mg/day (1600 mg twice daily) is reached.
• PO (Children 1 yr): 10 mg/kg/day in two divided doses; ↑ by 10 mg/kg every 2 days until a maximum daily dose of 45 mg/kg/day or 3200 mg/day given in 2 divided doses, whichever is less, is reached.

Banzel

• Although antiepileptic mechanism is unknown, rufinamide modulates the activity of sodium channels, prolonging the inactive state of the channel.

• Decreased incidence and severity of seizures associated with Lennox-Gastaut syndrome.

Therapeutic Classification: anticonvulsants

Pharmacologic Classification: triazoles

Absorption: 85% absorbed following oral administration; food enhances absorption.

Distribution: Evenly distributed between erythrocytes and plasma.

Metabolism/Excretion: Extensively metabolized; metabolites are primarily renally excreted.

Half-life: 6–10 hr.

• Instruct patient to take rufinamide around the clock, as directed. Medication should be gradually discontinued over by 25% every 2 days to prevent seizures. Advise patient to read the Medication Guide before starting therapy and with each Rx refill.
• May cause drowsiness, dizziness, ataxia, and incoordination. Caution patient to avoid driving or other activities requiring alertness until response to medication is known. Tell patient not to resume driving until health care professional gives clearance based on control of seizure disorder.
• Inform patients and families of risk of suicidal thoughts and behavior and advise that behavioral changes, emergence or worsening signs and symptoms of depression, unusual changes in mood, or emergence of suicidal thoughts, behavior, or thoughts of self-harm should be reported to health care professional immediately.
• Instruct patient to notify health care professional if signs of DRESS hypersensitivity reactions (fever, rash, fatigue, jaundice, dark urine) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications and to avoid taking alcohol or other CNS depressants concurrently with rufinamide.
• Rep: Advise females of reproductive potential to use an additional nonhormonal method of contraception during therapy and until next menstrual period. Instruct patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Encourage patients who become pregnant to enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334 or on the web at . Enrollment must be done by patients themselves.

roo-FIN-a-mide

NDC Code^*

• 62856- Eisai Inc.
  • 62856-582- Banzel
    • 62856-582-04- 4 TABLET, FILM COATED in 1 BOTTLE (62856-582-04)

• 62856- Eisai Inc.
  • 62856-582- Banzel
    • 62856-582-52- 120 TABLET, FILM COATED in 1 BOTTLE (62856-582-52)

• 62856- Eisai Inc.
  • 62856-583- Banzel
    • 62856-583-14- 14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14)

• 62856- Eisai Inc.
  • 62856-583- Banzel
    • 62856-583-52- 120 TABLET, FILM COATED in 1 BOTTLE (62856-583-52)

• 62856- Eisai Inc.
  • 62856-584- Banzel
    • 62856-584-46- 1 BOTTLE in 1 CARTON (62856-584-46) > 460 mL in 1 BOTTLE