Active Ingredient: Rufinamide
Rufinamide is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
10 - 45 mg per kg of body weight
From 5 To 22.5 mg per kg of body weight 2 time(s) per day every day
Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day every third day to a target dose of 45 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. For this patient population, the maximum recommended dose is 45 mg/kg/day.
As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients being co-administered valproate. Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day every third day to a target dose of 30 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. For this patient population, the maximum recommended dose is 30 mg/kg/day.
If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest whole 100 mg tablet.
Treatment should be initiated at a daily dose of 200 mg. According to clinical response and tolerability, the dose may be increased by 200 mg/day increments, as frequently as every third day, up to a maximum recommended dose of 1,000 mg/day.
Doses of up to 3,600 mg/day have been studied in a limited number of patients.
As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients <30 kg being co-administered valproate. Treatment should be initiated at a daily dose of 200 mg. According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/day, to the maximum recommended dose of 600 mg/day.
Patients >30 kg not receiving valproate
Treatment should be initiated at a daily dose of 400 mg. According to clinical response and tolerability, the dose may be increased by 400 mg/day increments, as frequently as every other day, up to a maximum recommended dose as indicated in the table below.
| Weight range | 30.0–50.0 kg | 50.1–70.0 kg | ≥70.1 kg |
| Maximum recommended dose | 1,800 mg/day | 2,400 mg/day | 3,200 mg/day |
Doses of up to 4,000 mg/day (in the 30-50 kg range) or 4,800 mg/day (in the over 50 kg) have been studied in a limited number of patients.
Treatment should be initiated at a daily dose of 400 mg. According to clinical response and tolerability, the dose may be increased by 400 mg/day increments, as frequently as every other day, up to a maximum recommended dose as indicated in the table below.
| Weight range | 30.0–50.0 kg | 50.1–70.0 kg | ≥70.1 kg |
| Maximum recommended dose | 1,200 mg/day | 1,600 mg/day | 2,200 mg/day |
Rufinamide should be administered with food.
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