roo-FIN-a-mide

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

• 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.

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.

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
• Pedi: Children <1 yr (safety and effectiveness not established); children <12 yr (↑ risk of drug reaction with eosinophilia and systemic symptoms [DRESS]).

CNS: SUICIDAL THOUGHTS, dizziness, fatigue, headache, somnolence.

EENT: diplopia.

CV: QT prolongation.

GI: nausea, changes in appetite.

GU: urinary frequency.

Derm: STEVENS-JOHNSON SYNDROME, rash.

Hemat: anemia.

Neuro: ataxia, coordination abnormalities, gait disturbances.

Misc: DRESS, hypersensitivity reactions (↑ in children).

Drug-Drug:

• Potent inducers of the CYP450 enzyme including carbamazepine, phenytoin, primidone, and phenobarbital↑ clearance and may ↓ blood levels.
• Valproate↓clearance and may ↑ blood levels; 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 ↓ blood levels and effectiveness of hormonal contraceptives.
• May ↑ blood levels of phenytoin.

• PO (Adults): 400–800 mg/day in two divided doses, ↑ by 400–800 mg 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.

• PO: Administer with food. Tablets can be cut in half for dosing flexibility. Tablets may be administered as whole or half tablets, or crushed.
  • Use adaptor and syringe provided with oral suspension for accurate dosing.

Banzel

Therapeutic Classification: anticonvulsants

Pharmacologic Classification: triazoles

(Generic available)

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

• Assess location, duration, and characteristics of seizure activity. Institute seizure precautions.
• Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
• Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome or Toxic Epidermal Necrolysis. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
• Monitor for signs and symptoms of DRESS (fever, rash, lymphadenopathy, and/or facial swelling, associated with involvement of other organ systems (hepatitis, nephritis, hematologic abnormalities, myocarditis, myositis) during therapy. May resemble an acute viral infection. Eosinophilia is often present. Discontinue therapy if signs occur.

• May cause leukopenia, anemia, neutropenia, and thrombocytopenia.

• Risk for injury (Indications).

• 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, emergency 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 female patients 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. Encourage patients who become pregnant to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or on the web at . Enrollment must be done by patients themselves.

• Decreased frequency and intensity of seizure activity.

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