Rufinamide

Usage

  • 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.

Rufinamide

Side effects

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 anticonvulsants 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.

Dosing

  • The below initiation and escalation doses are only a guide and need to be individualised based on patient (age, weight, co-morbidities), disease (seizure type, frequency, duration) and medication (metabolism, interactions, side-effect profile) characteristics.

 

  • Situations that require more careful consideration include children with higher weights, polytherapy, or multiple co-morbidities. Consultation with appropriate formularies or a paediatric neurologist may be required in specific circumstances.

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

Interactions | Precautions

    Contraindications

    • 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 anticonvulsants are potentially teratogenic and this is often dose-related (see section: AED Prescribing - Pregnancy)
    • There is limited data on the safety of Rufinamide in pregnancy.
    • Usage in pregnancy needs to be discussed with a neurologist

     

    Information last reviewed: 5/05/2023.