The
Pharmaceutical Journal
Vol 279 No 7470 p323
22 September 2007
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New medicines Composition: Rufinamide. Patients <30kg not receiving valproate: initially 200mg/day, increased in 200mg/day increments every two days (minimum interval) according to clinical response up to a maximum recommended dose of 1,000mg/day; doses of up to 3,600mg/day have been studied in a limited number of patients. Patients <30kg receiving concurrent valproate: 200mg/day, increased after a minimum of two days to a maximum dose of 400mg/day. Patients >30kg:
initially 400mg/day, increased in 400mg/day increments every two days
(minimum interval) up to a maximum dose of 1,800mg/day for 30–50kg
weight, 2,400mg/day for >50–70kg and 3,200mg/day for >70kg;
doses of up to 4,000mg/day (30–50kg) or 4,800mg/day (>50kg)
have been studied in a limited number of patients. Inovelon is not recommended for patients with severe hepatic impairment. Cases of status epilepticus have been observed with rufinamide but not placebo in clinical studies. If a patient develops new seizure types or an increased frequency of status epilepticus that is different from baseline, therapy should be reassessed. Treatment has been associated with dizziness, somnolence, ataxia and gait disturbances, which could increase the risk of falls. Patients must be advised to exercise caution during activities requiring a high degree of alertness. Serious antiepileptic drug hypersensitivity syndrome has occurred in association with rufinamide treatment. If this reaction is suspected, rufinamide treatment should be discontinued. All patients who develop rash should be monitored closely. Women of childbearing potential must use contraceptive measures during Inovelon treatment. Rufinamide concentrations may be decreased by co-administration with carbamazepine, phenobarbital, phenytoin, vigabatrin or primidone. Rufinamide may decrease phenytoin clearance and increase phenytoin steady state plasma concentrations — phenytoin dose reduction should be considered. Rufinamide
has been shown to induce CYP3A4 and may decrease the plasma concentration
of drugs highly metabolised by this enzyme. Common (>1/100, <1/10) pneumonia,
influenza, nasopharyngitis, ear infection, sinusitis, rhinitis, anorexia,
eating
disorder, decreased appetite, anxiety, insomnia, status epilepticus,
convulsion, abnormal co-ordination, nystagmus, psychomotor hyperactivity,
tremor, diplopia, blurred vision, vertigo, epistaxis, upper abdominal
pain, constipation,
dyspepsia, diarrhoea, rash, acne, back pain, oligomenorrhoea, gait disturbance,
decreased weight. |
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