Product: Banzel

Company: Eisai

Pharmacologic class: Anti-epileptic (triazole)

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Active ingredient: Rufinamide 200 mg, 400 mg; scored tabs.

Indication: Adjunctive treatment of seizures in Lennox-Gastaut syndrome (LGS).

Pharmacology: LGS is a seizure disorder characterized by multiple and frequent seizures. The onset usually occurs in patients aged 1-5 years. Symptoms include several seizure types such as tonic, atonic, and absence seizures. Atonic seizures lead to sudden falls known as “drop attacks,” a primary cause of injury. Tonic-clonic, myoclonic, and other seizure types can also occur.

Rufinamide is a novel anti-epileptic agent that is unrelated to currently available anti-epileptic drugs (AEDs). It has been shown to prolong the inactive state of sodium channels, but its precise mechanism of action in treating seizures is unknown. 

Clinical trials: A study was conducted to evaluate the effectiveness of rufinamide as adjunctive therapy in the treatment of seizures associated with LGS. The study enrolled patients aged 4-30 years with inadequately controlled seizures (including atypical absence and drop attacks) who were taking one to three concomitant stable-dose AEDs and who had at least 90 seizures in the previous month. Following a baseline stabilization phase, either rufinamide or placebo was added to the therapeutic regimen for 12 weeks. The primary efficacy variables were the percent change in total seizure frequency per 28 days, the percent change in tonic-atonic seizure frequency per 28 days, and seizure severity (a parent/guardian global evaluation of the patient’s condition). Results of the study indicated that patients given rufinamide had a significantly greater reduction in total seizure frequency and in frequency of tonic-atonic seizure along with improvements in the seizure severity rating from the global evaluation.

Adults: Take with food in two equally divided doses. Initially 400-800 mg per day; increase by 400-800 mg/day every two days to target of 3,200 mg/day. Avoid abrupt cessation (reduce dose by 25% every two days).

Children: Take with food in two equally divided doses. <4 years: not recommended. >4 years: initially 10 mg/kg per day; increase every other day by 10 mg/kg to target 45 mg/kg per day or 3,200 mg/day (whichever is less). Avoid abrupt cessation (reduce dose by 25% every two days).

Contraindications: Familial short QT syndrome.

Precautions: Severe hepatic impairment: not recommended. Mild-to-moderate hepatic impairment. Dialysis (may adjust dose). Depression or suicidal ideation (monitor). Pregnancy (Cat. C). Nursing mothers: not recommended.

Interactions: Caution with drugs that shorten QT interval. Central nervous system (CNS) depression with alcohol, other CNS depressants. Antagonizes carbamazepine, lamotrigine. May potentiate phenobarbital, phenytoin, triazolam. Potentiated by valproate (reduce doses). Antagonized by carbamazepine, phenobarbital, primidone, phenytoin. May affect substrates of CYP3A4, CYP2E1 (monitor). Antagonizes hormonal contraceptives (use non-hormonal forms too). May be affected by inducers or inhibitors of carboxylesterases.

Adverse reactions: Somnolence, fatigue, incoordination, dizziness, gait disturbances, ataxia, headache, GI upset, visual disturbances, leukopenia, fever/rash (monitor for multi-organ hypersensitivity reaction).

How supplied: Tabs 200 mg—30; 400 mg—120.

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