Inovelon (Rufinamide)
Antiepileptic for Lennox-Gastaut Syndrome
Quick Facts About Inovelon
Key Takeaways About Inovelon
- Specifically designed for Lennox-Gastaut syndrome: Inovelon is one of only a few medications specifically approved as adjunctive therapy for this severe epilepsy syndrome in patients from 1 year of age
- Always used with other antiepileptics: Inovelon is an add-on therapy and must be taken alongside other seizure medications, never as a sole treatment
- Dose depends on weight and co-medications: The maximum daily dose is significantly lower when taken with valproate due to a pharmacokinetic interaction that increases rufinamide levels
- Must be taken with food: Food significantly improves the absorption of rufinamide, so tablets should always be taken during or after meals
- Never stop abruptly: Sudden discontinuation can lead to an increase in seizure frequency and severity, including status epilepticus. Always taper gradually under medical supervision
What Is Inovelon and What Is It Used For?
Inovelon contains the active substance rufinamide, an antiepileptic drug used as adjunctive (add-on) therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in adults, adolescents, and children from 1 year of age. It works by modulating sodium channels in the brain to reduce seizure activity.
Rufinamide belongs to a group of medicines called antiepileptics (also known as anticonvulsants or antiseizure medications). These medicines work by reducing excessive electrical activity in the brain that causes seizures. Specifically, rufinamide is a triazole derivative that has a unique mechanism of action: it prolongs the inactive state of voltage-gated sodium channels, thereby limiting the sustained repetitive firing of neurons that underlies seizure propagation.
Lennox-Gastaut syndrome (LGS) is a severe form of childhood-onset epilepsy that typically begins between the ages of 1 and 8 years. It is characterised by three key features: multiple types of seizures (including tonic seizures, atonic or “drop” seizures, and atypical absence seizures), cognitive impairment or intellectual disability that often worsens over time, and a distinctive electroencephalogram (EEG) pattern showing slow spike-and-wave complexes. LGS accounts for approximately 1–4% of all childhood epilepsies but represents one of the most treatment-resistant forms of the condition.
The seizures in LGS are notoriously difficult to control and frequently resist standard antiepileptic medications. Patients typically require multiple medications used in combination. Inovelon was developed specifically to address this unmet medical need and was approved by the European Medicines Agency (EMA) in 2007 based on clinical trial data showing a significant reduction in total seizure frequency, with a particularly strong effect on tonic-atonic (drop) seizures.
It is important to understand that Inovelon is not a cure for Lennox-Gastaut syndrome. The goal of treatment is to reduce the number and severity of seizures, which can improve quality of life and reduce the risk of seizure-related injuries (particularly from drop seizures). Your doctor has prescribed Inovelon because they believe it will help reduce your seizure burden when added to your existing epilepsy treatment regimen.
Rufinamide was first approved for use in the European Union in 2007 under the brand name Inovelon. It was subsequently approved by the US Food and Drug Administration (FDA) in 2008 under the brand name Banzel. It is one of only a handful of medications that have been specifically studied and approved for Lennox-Gastaut syndrome, a condition for which treatment options remain limited.
What Should You Know Before Taking Inovelon?
Before starting Inovelon, inform your doctor about all your medical conditions, particularly any heart rhythm abnormalities (especially congenital short QT syndrome), liver disease, or history of suicidal thoughts. Tell your doctor about all other medications you take, including hormonal contraceptives, as Inovelon may reduce their effectiveness.
Contraindications
You should not take Inovelon if any of the following apply to you:
- Allergy to rufinamide or triazole derivatives – or to any of the other ingredients in the tablet (listed in the section “What Does Inovelon Contain?”). Symptoms of an allergic reaction may include skin rash, itching, swelling, or difficulty breathing
- Congenital short QT syndrome – a rare inherited condition affecting the electrical activity of the heart. Rufinamide may further shorten the QT interval, which could potentially trigger dangerous heart rhythm disturbances
Warnings and Precautions
Talk to your doctor or pharmacist before taking Inovelon if any of the following conditions apply:
- Congenital short QT syndrome or a family history of this condition – rufinamide has been shown to shorten the QT interval on electrocardiogram (ECG), which could worsen this condition and increase the risk of cardiac arrhythmias
- Liver problems – there is limited information on the use of rufinamide in patients with hepatic impairment. Your doctor may need to increase the dose more slowly than usual, and if your liver disease is severe, your doctor may decide that Inovelon is not suitable for you
- Skin rash or fever – these may be signs of an allergic reaction. Contact your doctor immediately if you develop a rash, as in rare cases this can become severe (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS syndrome, or Stevens-Johnson syndrome)
- Increase in seizures – if the number, severity, or duration of your seizures increases during treatment, contact your doctor immediately
- Walking difficulties, abnormal movements, dizziness, or drowsiness – these are known side effects that should be reported to your doctor, especially if they affect your daily activities
- Thoughts of self-harm or suicide – a small number of patients treated with antiepileptic medicines have experienced such thoughts. If you ever have thoughts of harming yourself, contact your doctor or go to a hospital immediately
Antiepileptic medications, including rufinamide, have been associated with a small increased risk of suicidal thoughts and behaviour. This risk has been identified across the entire class of antiepileptic drugs. If you or someone you care for experiences new or worsening depression, unusual changes in mood or behaviour, or thoughts of self-harm, seek medical attention immediately. Do not stop the medication without first consulting your doctor, as abruptly stopping an antiepileptic can trigger worsened seizures.
Use in Children
Inovelon is approved for use in children from 1 year of age as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. It should not be given to children under 1 year of age, as there is insufficient data on safety and efficacy in this age group. All paediatric dosing should be determined and monitored by a specialist paediatric neurologist or epileptologist.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your doctor before taking Inovelon. You should only take Inovelon during pregnancy if your doctor advises you to do so, after carefully weighing the potential benefits against the risks to the unborn child. Women with epilepsy face particular challenges during pregnancy because uncontrolled seizures also carry risks for both mother and baby.
Breastfeeding: It is not known whether rufinamide passes into breast milk. You should not breastfeed while taking Inovelon unless your doctor has advised otherwise. If you are breastfeeding or plan to breastfeed, discuss the risks and benefits with your doctor.
Contraception: If you are a woman of childbearing potential, you must use an effective method of contraception while taking Inovelon. Importantly, rufinamide can reduce the effectiveness of hormonal contraceptives (including the combined oral contraceptive pill, minipill, implants, and hormonal patches). Therefore, you should use an additional or alternative non-hormonal method of contraception (such as a condom, diaphragm, or copper intrauterine device) to ensure reliable pregnancy prevention.
Driving and Operating Machinery
Inovelon may cause dizziness, drowsiness, blurred vision, and impaired coordination, particularly at the start of treatment or after dose increases. If you experience any of these effects, do not drive, cycle, or operate machinery until the symptoms have resolved. Your ability to react may also be impaired even if you do not feel obviously affected. Discuss with your doctor whether it is safe for you to drive.
Important Information About Some Ingredients
Lactose: Inovelon tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per daily dose, meaning it is essentially “sodium-free”.
How Does Inovelon Interact with Other Drugs?
Inovelon interacts with several important medications, including valproate (which increases rufinamide levels), certain other antiepileptics, hormonal contraceptives (reduced effectiveness), warfarin, and digoxin. Always inform your doctor about all medications you are taking, including over-the-counter products.
Although rufinamide is not primarily metabolised through the cytochrome P450 (CYP) enzyme system (it is mainly broken down by carboxylesterases), it does have clinically significant interactions with several commonly used medications. The most important interaction is with valproate, which substantially increases rufinamide blood levels. Understanding these interactions is essential for safe and effective treatment.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Valproate (valproic acid, sodium valproate) | Antiepileptic | Significantly increases rufinamide blood levels (by up to 70% in children and 16–46% in adults), leading to higher drug exposure | Maximum daily dose of Inovelon must be reduced. Close monitoring required |
| Hormonal contraceptives (pill, patch, implant) | Contraception | Rufinamide reduces the effectiveness of hormonal contraceptives, increasing the risk of unintended pregnancy | Use an additional non-hormonal contraceptive method (e.g. condom, copper IUD) |
| Phenobarbital / Primidone | Antiepileptic / Barbiturate | Rufinamide may slightly reduce the effectiveness of these drugs. Starting or stopping rufinamide may alter their blood levels | Close monitoring for 2 weeks when starting or stopping rufinamide, or after significant dose changes |
| Phenytoin / Fosphenytoin | Antiepileptic | Rufinamide may slightly reduce phenytoin levels. Phenytoin may also affect rufinamide levels | Close monitoring for 2 weeks when starting or stopping rufinamide, or after dose changes |
Other Notable Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Warfarin | Anticoagulant (blood thinner) | Rufinamide may affect warfarin metabolism and alter its blood-thinning effect | Monitor INR closely when starting, stopping, or adjusting Inovelon dose |
| Digoxin | Heart medication | Rufinamide may alter digoxin blood levels | Monitor digoxin levels; dose adjustment may be needed |
| Carbamazepine | Antiepileptic | Carbamazepine may decrease rufinamide levels through enzyme induction | Rufinamide dose may need adjustment; monitor seizure control |
| Lamotrigine | Antiepileptic | Limited interaction; may be used together | Standard monitoring; no routine dose adjustment needed |
If you are currently taking any other medications – including over-the-counter medicines, herbal products, or dietary supplements – you should inform your doctor or pharmacist before starting Inovelon. Some interactions may require dose adjustments or additional monitoring to ensure your safety.
What Is the Correct Dosage of Inovelon?
The dose of Inovelon is individualised based on age, body weight, and whether you are also taking valproate. Treatment is started at a low dose and gradually increased. Tablets must be taken twice daily with food. Always follow your doctor's dosing instructions precisely.
Always take Inovelon exactly as your doctor has told you. Do not change your dose without consulting your doctor first. It may take some time to find the dose that works best for you. Your doctor will calculate the appropriate dose based on your age, your weight, and whether you are also taking valproate (which significantly affects how much rufinamide your body is exposed to).
Children Aged 1 to 4 Years
Weight-Based Dosing
Starting dose: 10 mg per kg of body weight per day, divided into two equal doses (morning and evening)
Dose increases: May be increased by 10 mg per kg per day every third day, as directed by your doctor
Maximum dose without valproate: 45 mg per kg per day
Maximum dose with valproate: 30 mg per kg per day
Children Over 4 Years Weighing Less Than 30 kg
Fixed Dosing
Starting dose: 200 mg per day, divided into two equal doses (100 mg morning and 100 mg evening)
Dose increases: May be increased by 200 mg per day every third day
Maximum dose without valproate: 1,000 mg per day
Maximum dose with valproate: 600 mg per day
Adults, Adolescents, and Children Weighing 30 kg or More
Standard Adult Dosing
Starting dose: 400 mg per day, divided into two equal doses (200 mg morning and 200 mg evening)
Dose increases: May be increased by 400 mg per day every other day
Maximum dose without valproate: Up to 3,200 mg per day (depending on body weight)
Maximum dose with valproate: Up to 2,200 mg per day (depending on body weight)
Some patients may respond to a lower dose. Your doctor will adjust the dose based on your individual response and tolerance to the medication.
How to Take Inovelon
Inovelon tablets must be taken twice daily with food – once in the morning and once in the evening. Food significantly increases the absorption of rufinamide, so it is important not to take the tablets on an empty stomach. Swallow the tablets with a glass of water.
If you have difficulty swallowing tablets, you can:
- Crush the tablet and mix the powder with approximately half a glass (100 ml) of water. Drink the mixture immediately after preparation
- Break the tablet in half along the score line and swallow the halves with water
Missed Dose
If you forget to take a dose, simply continue taking your medicine at the usual time. Do not take a double dose to make up for the missed one. If you miss more than one dose, consult your doctor for advice.
Overdose
If you have accidentally taken more Inovelon than prescribed, contact your doctor, pharmacist, or your nearest emergency department immediately. Take the medicine packaging with you so that the medical team knows exactly what has been taken and in what amount. Symptoms of overdose may include increased drowsiness, dizziness, nausea, and unsteadiness.
Stopping Inovelon
You should never stop taking Inovelon without consulting your doctor first. If your doctor decides to discontinue your treatment, they will provide you with instructions on how to gradually reduce the dose over time. This gradual tapering is essential because suddenly stopping an antiepileptic medication can cause a dangerous increase in seizure frequency, including the risk of status epilepticus (prolonged or repeated seizures without recovery), which is a medical emergency.
What Are the Side Effects of Inovelon?
The most common side effects of Inovelon include dizziness, headache, nausea, vomiting, drowsiness, and fatigue. These affect more than 1 in 10 patients. Most side effects are mild to moderate and often improve as your body adjusts to the medication. Report any new or worsening symptoms to your doctor.
Like all medicines, Inovelon can cause side effects, although not everybody gets them. Side effects are often dose-related, meaning they may be more likely or more severe at higher doses. If your doctor increases your dose and you experience troublesome side effects, they may choose to slow the rate of dose escalation or reduce the dose.
- Skin rash or fever – this may be a sign of a serious allergic reaction (DRESS syndrome or Stevens-Johnson syndrome). Contact your doctor or go to hospital immediately
- Changes in your seizure pattern – if your seizures become more frequent, more severe, or last longer than usual (status epilepticus), seek emergency medical care
- Thoughts of self-harm or suicide – contact your doctor or go to hospital immediately if you experience any thoughts of harming yourself
Very Common
May affect more than 1 in 10 people
- Dizziness
- Headache
- Nausea
- Vomiting
- Drowsiness (somnolence)
- Fatigue and tiredness
Common
May affect up to 1 in 10 people
- Walking difficulties (gait disturbance)
- Abnormal movements (involuntary movements)
- Convulsions or seizures
- Unusual eye movements (nystagmus)
- Blurred vision
- Tremor (shaking)
- Abdominal (stomach) pain
- Constipation
- Indigestion (dyspepsia)
- Loose stools (diarrhoea)
- Decreased or altered appetite
- Weight loss
- Anxiety
- Insomnia (difficulty sleeping)
- Nosebleeds (epistaxis)
- Acne
- Skin rash
- Back pain
- Irregular or infrequent menstrual periods (oligomenorrhoea)
- Bruising
- Head injury (as a consequence of seizure-related falls)
- Ear infection
- Influenza-like illness
- Nasal congestion
- Upper respiratory tract infection
Uncommon
May affect up to 1 in 100 people
- Allergic reactions (hypersensitivity)
- Elevated liver enzymes (increased liver function markers)
If you experience any side effects not listed above, or if any side effect becomes severe or persistent, tell your doctor or pharmacist. You can also report suspected side effects directly to your national medicines regulatory authority, which helps ongoing monitoring of the medicine's benefit–risk balance.
Many common side effects of Inovelon, such as dizziness and drowsiness, tend to be most pronounced when treatment is first started or when the dose is increased. They often improve as your body adjusts to the medicine over the first few weeks. If side effects are troublesome, speak with your doctor – it may be possible to slow the rate of dose increase or adjust your treatment regimen.
How Should You Store Inovelon?
Store Inovelon tablets at or below 30°C, in the original packaging, out of the reach and sight of children. Do not use after the expiry date printed on the blister and carton.
Keep this medicine out of the sight and reach of children at all times. Check the expiry date before taking any tablets – the expiry date refers to the last day of the stated month. Do not use Inovelon if you notice any change in the appearance of the tablets.
Store the tablets in their original blister packaging to protect them from moisture. Do not store above 30°C. There are no other special storage requirements.
Do not dispose of unused tablets by flushing them down the toilet or throwing them in household waste. Return any unused or expired medication to your pharmacist for safe disposal. This helps protect the environment from pharmaceutical contamination.
What Does Inovelon Contain?
Each Inovelon tablet contains the active ingredient rufinamide, available in 100 mg, 200 mg, and 400 mg strengths. The tablets also contain lactose monohydrate and several standard pharmaceutical excipients. All tablet strengths are pink, oval, film-coated, and scored on both sides.
Active Ingredient
The active substance is rufinamide. Each film-coated tablet contains either 100 mg, 200 mg, or 400 mg of rufinamide, depending on the tablet strength.
Inactive Ingredients (Excipients)
The other ingredients in the tablet core are: lactose monohydrate, microcrystalline cellulose (E460), maize starch, croscarmellose sodium (E468), hypromellose (E464), magnesium stearate, sodium lauryl sulfate, and colloidal anhydrous silica. The film coating consists of hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, and red iron oxide (E172).
Tablet Appearance and Packaging
100 mg tablets: Pink, oval, slightly convex, film-coated tablets scored on both sides, imprinted “Ε261” on one side and plain on the other. Available in packs of 10, 30, 50, 60, and 100 tablets.
200 mg tablets: Pink, oval, slightly convex, film-coated tablets scored on both sides, imprinted “Ε262” on one side and plain on the other. Available in packs of 10, 30, 50, 60, and 100 tablets.
400 mg tablets: Pink, oval, slightly convex, film-coated tablets scored on both sides, imprinted “Ε263” on one side and plain on the other. Available in packs of 10, 30, 50, 60, 100, and 200 tablets.
Not all pack sizes may be marketed in every country.
How Does Inovelon Work in the Body?
Rufinamide works by prolonging the inactive state of voltage-gated sodium channels in nerve cells. This stabilises neuronal membranes and prevents the rapid, repetitive firing of electrical signals that causes seizures. Its unique mechanism makes it effective against the multiple seizure types seen in Lennox-Gastaut syndrome.
The brain normally functions through carefully controlled electrical signals passing between nerve cells (neurons). In epilepsy, groups of neurons can become overexcitable and fire uncontrolled electrical impulses, which spread through the brain and cause seizures. The type and severity of the seizure depends on where in the brain the abnormal activity begins and how far it spreads.
Rufinamide modulates the activity of voltage-gated sodium channels, which are protein structures on the surface of nerve cells that control the flow of sodium ions in and out of the cell. These channels are essential for generating and propagating electrical signals along nerves. By prolonging the inactive (or “refractory”) state of these channels, rufinamide makes it harder for neurons to fire rapid, sustained bursts of electrical activity – the type of activity that underlies seizure propagation.
This mechanism of action is distinct from many other antiepileptic drugs, which is why rufinamide can be effective in patients who have not responded adequately to other medications. It appears to be particularly effective against tonic and atonic seizures (“drop attacks”), which are among the most dangerous seizure types in LGS because they can cause sudden falls and serious injuries.
Pharmacokinetic Profile
After oral administration, rufinamide is well absorbed from the gastrointestinal tract, with absorption being significantly enhanced when taken with food. The elimination half-life is approximately 6–10 hours, which is why the medicine needs to be taken twice daily to maintain adequate blood levels throughout the day.
Unlike many other antiepileptic drugs, rufinamide is not primarily metabolised by cytochrome P450 (CYP) enzymes. Instead, it is mainly broken down by carboxylesterases through hydrolysis, with the resulting metabolites being pharmacologically inactive. This metabolic profile means that rufinamide has fewer drug interactions related to CYP enzyme inhibition or induction compared to many other anticonvulsants. However, it does have significant interactions with valproate and can affect hormonal contraceptive efficacy.
Plasma protein binding of rufinamide is relatively low (approximately 26–35%), and it is primarily excreted by the kidneys as inactive metabolites. Steady-state plasma concentrations are typically reached within 2 days of starting therapy due to the relatively short half-life.
Frequently Asked Questions About Inovelon
Inovelon (rufinamide) is used as adjunctive (add-on) therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in adults, adolescents, and children from 1 year of age. LGS is a severe form of childhood-onset epilepsy characterised by multiple seizure types, cognitive impairment, and a distinctive EEG pattern. Inovelon is always used in combination with other antiepileptic medications, not as a standalone treatment.
The most common side effects of Inovelon (affecting more than 1 in 10 people) include dizziness, headache, nausea, vomiting, drowsiness (somnolence), and fatigue. Common side effects (affecting up to 1 in 10 people) include walking difficulties, tremor, blurred vision, abdominal pain, constipation, loss of appetite, weight loss, and skin rash. Most side effects are mild and tend to improve as your body adjusts to the medication.
Yes, Inovelon is frequently used alongside valproate in the treatment of Lennox-Gastaut syndrome. However, valproate significantly increases rufinamide blood levels, which means the maximum daily dose of Inovelon must be reduced. For children weighing less than 30 kg, the maximum dose drops from 1,000 mg/day to 600 mg/day. For patients weighing 30 kg or more, the maximum decreases from 3,200 mg/day to 2,200 mg/day. Your doctor will determine the appropriate dose.
Inovelon tablets should be taken twice daily (morning and evening) with food, as food significantly increases the absorption of rufinamide. Swallow the tablets with water. If you have difficulty swallowing, you can crush the tablets and mix them with approximately half a glass (100 ml) of water, then drink immediately. You can also break the scored tablets in half. Never stop taking Inovelon suddenly without consulting your doctor.
Inovelon is approved for use in children from 1 year of age as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome. It is not recommended for children under 1 year due to insufficient safety data. The dose is carefully calculated based on the child's body weight and whether they are also taking valproate. All paediatric treatment should be initiated and supervised by a specialist paediatric neurologist or epileptologist.
You should never stop taking Inovelon suddenly without medical advice. Abrupt discontinuation of antiepileptic medications can lead to a dangerous increase in seizure frequency and severity, including the risk of status epilepticus (prolonged seizures that do not stop on their own), which is a medical emergency. If your doctor decides to stop Inovelon, the dose will be gradually reduced over time to minimise withdrawal risks.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.
- European Medicines Agency (EMA). Inovelon (rufinamide) – Summary of Product Characteristics. EMA product information database. Accessed January 2026.
- Glauser T, Kluger G, Sachdeo R, et al. Rufinamide for generalized seizures associated with Lennox-Gastaut syndrome. Neurology. 2008;70(21):1950–1958. doi:10.1212/01.wnl.0000303813.95800.0d
- Kluger G, Glauser T, Krauss G, et al. Adjunctive rufinamide in Lennox-Gastaut syndrome: a long-term, open-label extension study. Acta Neurologica Scandinavica. 2010;122(3):202–208.
- Cross JH, Auvin S, Falip M, et al. Expert opinion on the management of Lennox-Gastaut syndrome: treatment algorithms and practical considerations. Frontiers in Neurology. 2017;8:505. doi:10.3389/fneur.2017.00505
- National Institute for Health and Care Excellence (NICE). Epilepsies in children, young people and adults. NICE guideline [NG217]. Updated 2022.
- Wirrell EC, Nabbout R, Bhatt DL, et al. ILAE classification and definition of epilepsy syndromes with onset at a variable age: position statement by the ILAE Commission on Classification and Terminology. Epilepsia. 2022;63(6):1443–1474.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
- British National Formulary (BNF). Rufinamide. NICE BNF monograph. Accessed January 2026.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in neurology, epileptology, and clinical pharmacology.
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