Triazole-derivative antiepileptic Pregnancy: Rufinamide should not be used during pregnancy, or in women of childbearing age not using contraceptive measures, unless clearly necessary — no clinical data on exposed pregnancies are available; animal studies showed foetotoxicity in the presence of maternal toxicity. Effective antiepileptic therapy should not be interrupted abruptly. Breast-feeding should be avoided during maternal treatment.

Rufinamide

Brand names: Inovelon

Rufinamide is an antiseizure medication used as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Adults, adolescents and children 4 years or older weighing 30 kg or over, NOT receiving valproate: initiate at 200 mg/day; according to clinical response and tolerability increase in 200 mg/day increments as frequently as every other day, up to the maximum recommended dose for body weight

Route: Oral — tablets taken with water and with food; if swallowing is difficult, tablets may be crushed and given in half a glass of water, or broken in two using the score line

Frequency: Twice daily, in two equally divided doses (morning and evening)

Max: Patients over 30 kg not receiving valproate — 30.0 to 50.0 kg: 1,800 mg/day; 50.1 to 70.0 kg: 2,400 mg/day; 70.1 kg and above: 3,200 mg/day. Patients over 30 kg also receiving valproate — 30.0 to 50.0 kg: 1,200 mg/day; 50.1 to 70.0 kg: 1,600 mg/day; 70.1 kg and above: 2,200 mg/day

Treatment should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy. Patients over 30 kg ALSO receiving valproate: initiate at 400 mg/day and increase in 400 mg/day increments as frequently as every other day, up to the lower weight-banded maxima listed above (valproate significantly decreases rufinamide clearance). Children 4 years or older weighing LESS than 30 kg, not on valproate: initiate 200 mg/day, increase in 200 mg/day increments as frequently as every third day, to a maximum recommended dose of 1,000 mg/day (doses up to 3,600 mg/day have been studied in a limited number of patients). Children under 30 kg also on valproate: initiate 200 mg/day and, after a minimum of 2 days, increase by 200 mg/day to a maximum recommended 600 mg/day. Doses of up to 4,000 mg/day (30–50 kg) or 4,800 mg/day (over 50 kg) have been studied in a limited number of patients. Discontinuation: withdraw gradually — in clinical trials the dose was reduced by approximately 25% every two days. Elderly: no dosage adjustment required over 65 years. Hepatic impairment: not studied — caution and careful dose titration in mild to moderate impairment; use in severe hepatic impairment is not recommended. Women of childbearing potential must use contraceptive measures during treatment.

Paediatric dose

Dose: 10 mg/kg

Route: Oral

Frequency: 10 mg/kg/DAY given as two equally divided doses approximately 12 hours apart — initiation dose for children 1 year to less than 4 years of age

Max: 45 mg/kg/day (maximum 30 mg/kg/day in patients co-administered valproate)

Children 1 year to less than 4 years, NOT receiving valproate: initiate 10 mg/kg/day in two equally divided doses about 12 hours apart; 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 in two equally divided doses — maximum recommended dose 45 mg/kg/day. Children 1 year to less than 4 years RECEIVING valproate: same 10 mg/kg/day starting dose, but target and maximum dose 30 mg/kg/day, because valproate significantly decreases rufinamide clearance. If the recommended calculated dose is not achievable, give to the nearest whole 100 mg tablet. Safety and efficacy in newborn infants, or infants and toddlers aged less than 1 year, have not been established — no data are available. Children 4 years and older are dosed by fixed mg/day weight bands, not per kg — see the adult dose fields. Verify against a children's formulary before prescribing. Source quote (eMC SPC §4.2): 'Use in children from 1 year to less than 4 years of age. Patients not receiving valproate: Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours... the dose may be increased by up to 10 mg/kg/day every third day to a target dose of 45 mg/kg/day... the maximum recommended dose is 45 mg/kg/day. Patients receiving valproate: ... target dose of 30 mg/kg/day ... the maximum recommended dose is 30 mg/kg/day.'

Dose adjustments

Renal

No dose adjustment is required in patients with severe renal impairment (based on a study in this population).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

Patient weight (kg)

Verify in a children's formulary

Contraindications

Hypersensitivity to the active substance, to triazole derivatives, or to any of the excipients

Side effects

Somnolence (very common) and headache, dizziness and fatigue (very common/common) — with ataxia, abnormal coordination and gait disturbance which may increase accidental falls
Nausea and vomiting (very common/common); abdominal pain upper, constipation, dyspepsia and diarrhoea (common)
Status epilepticus — observed during rufinamide treatment but not with placebo; led to discontinuation in 20% of those cases
Rash (common), and serious antiepileptic hypersensitivity syndrome including DRESS and Stevens-Johnson syndrome — discontinue if suspected and monitor all patients who develop a rash closely
QT shortening (rufinamide produced a concentration-proportional decrease in QTc); hepatic enzyme increase, decreased appetite and weight decrease

Interactions

Valproate significantly decreases rufinamide clearance — a lower maximum rufinamide dose is required, and patients on valproate should begin at a lower starting dose (10 mg/kg/day in paediatric patients or 400 mg/day in adults) [eMC §4.2; US label §7.2]
Hormonal contraceptives may be less effective with rufinamide — use additional non-hormonal forms of contraception; physicians should use clinical judgement on whether the oral contraceptive or its component doses are adequate [US label §7.3; eMC §4.4]
Rufinamide on other AEDs: carbamazepine decreased by 7–13%, lamotrigine decreased by 7–13%, phenobarbital increased by 8–13%, phenytoin increased by 7–21%, topiramate and valproate no effect [US label §7.1]
Other AEDs on rufinamide: carbamazepine decreases rufinamide by 19–26% (dose-dependent); phenobarbital and phenytoin decrease rufinamide by 25–46%; valproate increases rufinamide by <16 to 70% (dose-dependent) [US label §7.1]
Note: §4.5 of the UK SPC was not captured in the fetched text — check the UK SPC for the full interaction profile

Clinical monograph

How it works

It is thought to act by prolonging the inactive state of voltage-gated sodium channels, thereby limiting sustained, high-frequency neuronal firing.

Prescribing in practice

It can shorten the QT interval, so it is contraindicated in familial short QT syndrome and used with caution alongside other drugs that affect cardiac repolarisation.
Multi-organ hypersensitivity (drug reaction with eosinophilia and systemic symptoms) has been reported, typically early in treatment, and should prompt immediate discontinuation.
Valproate increases rufinamide exposure, so co-prescription may require dose adjustment.

Monitoring

Monitor seizure frequency and watch for hypersensitivity features such as rash with fever, alongside the usual vigilance for behavioural change and suicidal ideation seen with antiseizure drugs.

Counselling the patient

Take doses with food to aid absorption and tolerability.
Report any rash, particularly with fever or swollen glands, without delay.
Do not stop the medicine suddenly, as this can provoke seizures.

Evidence & guidelines

Rufinamide is licensed as adjunctive treatment for Lennox-Gastaut syndrome on the basis of randomised controlled trial evidence of reduced seizure frequency.

Reference: NICE NG217; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Pathways