Rufinamide | Epilepsy clinician handbook
Rufinamide is primarily used as adjunctive treatment for drug resistant seizures in Lennox-Gastaut syndrome, particularly for drop attacks.
It has also been used in other drug-resistant epilepsies, for example: myoclonic atonic epilepsy, structural and genetic related epilepsies.
Important: Dosing information
Initiation and escalation doses on this webpage are a guide only.
All medications must be individualised based on:
- patient age, weight, co-morbidities
- disease, seizure type, frequency, duration
- medication metabolism, interactions, side-effect profile characteristics.
Dosing
Commonly used regime
- Initial dose: 10mg/kg/day given in 2 divided doses
- For escalation dosage, titration of 5-10 mg/kg/day per week or fortnight is reasonable to minimise side effects.
- A common recommended maintenance dose for a child >4 and <30kg, is 30mg/kg/day. Lower doses may be effective.
- Dosages per kilogram can only be used up to weights of 30-40kgs. Please consult appropriate formularies for higher weights.
Preparations
- Tablets: 200mg and 400mg tablets. These may be crushed and given with water.
- Oral suspension: 40mg/mL
Possible side effects
- Somnolence and fatigue
- Nausea and vomiting
- Headache
- Dizziness
- Diplopia, blurred vision
- Constipation, diarrhoea
Other notable side effects
- Less commonly: weight loss, insomnia, anxiety
- Rarely: hypersensitivity reaction (fever, rash, lymphadenopathy, haematuria, deranged liver function tests)
- Decreases QTc interval, therefore patients with coexisting short QT syndrome or family history thereof may be at risk
- All anti-seizure medications are potentially teratogenic and this is often dose related (see section: AED Prescribing - Pregnancy)
- For a complete list of adverse effects, appropriate formularies should be consulted.
Interactions and precautions
- SCN1A-associated disorders (as rufinamide is a sodium channel drug).
- Rufinamide can decrease the QT interval. An ECG before starting treatment may be necessary and it should not be given to patients with a history of congenital short QT interval.
Precautions
- Co-administration with Sodium Valproate decreases the clearance of Rufinamide therefore lower dosage of Rufinamide is recommended (see formularies).
- Conversely, co-administration with enzyme-inducing drugs will tend to reduce plasma levels of Rufinamide and a higher dose of Rufinamide may be required.
- Rufinamide has been associated with a drug hypersensitivity reaction and Stevens-Johnson syndrome. The majority of reported cases have occurred in children <12 years age and within the first 4 weeks of starting Rufinamide therapy.
- Rufinamide enhances metabolism of oral contraceptives and potentially reduces their effectiveness.
Weaning
Gradual reduction (over a minimum of a week) minimises the risk of increased seizure frequency or status epilepticus in patients with seizure disorders.
Pregnancy
- All anti-seizure medications are potentially teratogenic and this is often dose related.
- There is limited data on the safety of Rufinamide in pregnancy.
- Usage in pregnancy needs to be discussed with a neurologist
Resources
This information is reviewed annually by the Sydney Children’s Hospitals Network Paediatric Epilepsy NSW working group which includes medical, nursing, and pharmacy representation.