Rufinamide: profile report
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Rufinamide: profile report Adapted and reproduced from CNS Drugs 2006; 20 (9): 751-61[1-3] Lennox-Gastaut syndrome is a devastating childhood epilepsy that is estimated to account for up to 10% of all childhood epilepsies.[4] The syndrome has an early childhood onset, with seizures typically beginning between 1 and 7 years of age, and is characterised by multiple types of seizures, slow spike-wave EEG patterns and mental retardation.[5] The most prevalent seizure types in these patients include atonic, tonic and atypical absence seizures,[5] although other seizure types are also seen.[4] Lennox-Gastaut syndrome is particularly difficult to treat, with the associated seizures often resistant and unresponsive to standard antiepileptic drugs (AEDs).[5] Second-line treatment options include a ketogenic diet, corpus callostomy and vagus nerve stimulation, all of which have varying rates of success.[4,5] Partial seizures, the most prevalent seizure type among patients with epilepsy,[6] are a consequence of neurons firing aberrantly within one or more localised areas of the brain.[7] The standard treatment for partial seizures is Table I. Features and properties of oral rufinamide (Inovelon®, Xilep™)[1] Patient population in pivotal trials Adjunctive treatment of seizures in patients aged ≥4y with Lennox-Gastaut syndrome and in adult and adolescent patients with partial seizures Mechanism of action Modulates neuronal sodium channel activity and limits neuronal action potential firing Dosage in clinical trials Lennox-Gastaut syndrome
Initial: 10 mg/kg/day Maximum: 45 mg/kg/day
Partial seizures
Initial: 200–1600 mg/daya Maximum: 3200 mg/day
Pharmacokinetic profile (after a single oral 400mg dose in healthy adult volunteers) Mean maximum plasma concentration (Cmax)
3.03 μg/mL
Mean time to Cmax
6.56h
Mean elimination half-life
8.82h
Most frequent adverse events (incidence ≥10%) Lennox-Gastaut syndrome
Somnolence, vomiting
Partial seizures (pooled data)
Headache, dizziness, fatigue, nausea, somnolence, diplopia
a The recommendation for the upper limit of the initial rufinamide dosage will be
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