Rufinamide, also known as Inovelon ) is an antiepileptic medication specifically indicated for treating seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children aged 1 year and older. It is used as an adjunctive therapy alongside other antiepileptic drugs to help control multiple seizure types characteristic of this severe epilepsy form.
| Type of medicine | An antiepileptic medicine |
|---|---|
| Used for | Seizures associated with Lennox-Gastaut syndrome in adults or in children over 1 year of age |
| Also called | Inovelon ) |
| Available as | Tablets (100 mg, 200 mg, 400 mg) and oral suspension |
About rufinamide
Lennox-Gastaut syndrome is a severe, rare form of epilepsy that typically begins in early childhood between ages 3 and 5, often persisting into adulthood. It is characterized by multiple seizure types including tonic, atonic (drop attacks), atypical absence, and tonic-clonic seizures, along with developmental delays, intellectual disability, behavioral issues, and specific EEG patterns.
Rufinamide belongs to a class of anticonvulsants that works by stabilizing electrical activity in the brain. As a triazole derivative structurally unrelated to other antiepileptics, it prolongs the inactive state of voltage-gated sodium channels, reducing excessive neuronal firing and preventing seizure spread. At high concentrations, it may also inhibit mGluR5 receptors to limit glutamate production.
Clinical evidence supports its efficacy: in pivotal trials, rufinamide reduced total seizure frequency by 33% versus 12% with placebo (p=0.0015), and drop attacks (tonic-atonic seizures) by 43% versus a 1.4% increase with placebo. Another study showed 42.5% reduction in tonic-atonic seizures (p<0.0001).
This medicine does not cure epilepsy but controls seizures while taken. It is available only by prescription in tablet and oral liquid forms.
How and when to take rufinamide
Take rufinamide exactly as prescribed. Doses are printed on the package label. Treatment starts at a low dose, gradually increasing to a maintenance level, typically divided into two daily doses: morning and evening.
- Adults: Initial dose 400-800 mg/day (200-400 mg twice daily), titrated up to 3200 mg/day maximum based on response.
- Children (over 1 year): 10 mg/kg/day initially (5 mg/kg twice daily), up to 45 mg/kg/day or 3200 mg/day max. Adjust for weight and suspension concentration (40 mg/mL or 250 mg/5 mL).
Swallow tablets whole with water, with or just after food to improve absorption (food increases bioavailability by 45-63%). Shake oral suspension well before use; use provided syringe for accurate dosing. If a dose is missed, take it as soon as remembered unless near the next dose—do not double up.
Take regularly every day; sudden stopping can worsen seizures. If discontinuation is needed, taper gradually under medical supervision.
Getting the most from your treatment
To optimize rufinamide’s benefits:
- Monitor seizure frequency and report changes to your doctor for dose adjustments.
- Avoid alcohol, as it may increase drowsiness.
- Do not drive or operate machinery until you know how it affects you, due to potential dizziness or sleepiness.
- Inform your doctor of all other medications, as rufinamide may interact with hormonal contraceptives (reducing efficacy—use non-hormonal methods), carbamazepine, phenytoin, valproate, or phenobarbitone.
- Regular blood tests may be needed to check levels and organ function.
Combining with other antiepileptics is standard; clinical studies used it adjunctively with up to three other AEDs.
Side-effects
Common side effects are usually mild and improve over time. Report persistent or severe issues to your doctor.
| Side-effect | What to do |
|---|---|
| Feeling dizzy, tired or sleepy | Do not drive and do not use tools or machines |
| Headache | Drink plenty of water and ask your pharmacist to recommend a suitable painkiller. If headaches continue or are severe, let your doctor know |
| Feeling sick (nausea) or being sick (vomiting) | Stick to simple meals – avoid rich or spicy food |
| Flu-like symptoms, nosebleeds, lack of appetite, anxiety, difficulties sleeping, poor coordination, unsteadiness on your feet, blurred vision or double vision, acne, constipation or diarrhoea | If any of these become troublesome, speak with your doctor for advice |
Trials reported somnolence (24% vs 13% placebo), vomiting (22% vs 6%), decreased appetite, and status epilepticus (rare). Weight loss, insomnia, and aggression may occur, especially in children.
Important: Seek immediate medical help for serious allergic reactions (DRESS syndrome): fever, rash, swollen glands, mouth sores, or liver issues. Other serious risks include QT shortening, suicidal thoughts, hypersensitivity, or multi-organ failure.
Precautions
- Heart conditions: Rufinamide shortens QT interval; ECG monitoring advised if history of QT issues.
- Mental health: May worsen depression or cause new suicidal ideation—monitor closely.
- Liver/kidney problems: Dose adjustments needed; avoid in severe cases.
- Family planning: Ineffective with hormonal contraceptives; use barrier methods. Discuss before pregnancy—may harm fetus. Use effective contraception if applicable.
Breastfeeding: Limited data; weigh risks/benefits.
Pregnancy and breastfeeding
Rufinamide may harm the unborn baby; animal studies show risks. Use only if benefits outweigh risks, with contraception advised. Enroll in pregnancy registries if pregnant. Data on breastfeeding passage is limited—consult doctor.
Frequently asked questions
Who can take rufinamide?
Adults and children over 1 year with LGS seizures inadequately controlled by other AEDs.
How quickly does rufinamide work?
Benefits seen within 2-4 weeks; full effects after dose titration.
Can I stop rufinamide suddenly?
No—taper gradually to avoid seizure worsening.
Does rufinamide interact with other drugs?
Yes, notably enzyme inducers (carbamazepine) reduce levels; valproate increases them. Check with pharmacist.
Is rufinamide safe long-term?
Used long-term under monitoring; regular check-ups needed.
This article provides general information; always consult your healthcare provider for personalized advice.
References
- Rufinamide for epilepsy – Patient.info — Patient.info. 2023. https://patient.info/medicine/rufinamide-for-epilepsy-inovelon
- Rufinamide for seizures – PMC — National Center for Biotechnology Information. 2019-02-01. https://pmc.ncbi.nlm.nih.gov/articles/PMC6370605/
- Rufinamide: MedlinePlus Drug Information — MedlinePlus. 2023. https://medlineplus.gov/druginfo/meds/a609001.html
- EISAI ANNOUNCES LAUNCH OF ANTIEPILEPTIC AGENT INOVELON® — Eisai Co., Ltd. 2013-10-17. https://www.eisai.com/news/news201331.html
- Rufinamide: Uses, Interactions, Mechanism of Action | DrugBank — DrugBank Online. 2024. https://go.drugbank.com/drugs/DB06201
