Inovelon - rufinamide

What is Inovelon?

Inovelon is a drug containing the active ingredient rufinamide. It is available as pink oval tablets containing 100 mg, 200 mg or 400 mg of rufinamide.

What is Inovelon used for?

Inovelon is indicated in patients 4 years of age and older for the treatment of Lennox-Gastaut syndrome, a rare form of epilepsy that usually affects children but can continue into adulthood. Lennox-Gastaut syndrome is a of the most severe forms of epilepsy in children Symptoms include various forms of seizures, excessive electrical activity in the brain, learning difficulties and behavioral disturbances Inovelon is indicated as an add-on to other antiepileptic drugs.
Since the number of patients with Lennox-Gastaut syndrome is low, the disease is considered rare and Inovelon was designated an 'orphan medicine' (a medicine used in rare diseases) on 20 October 2004.
The medicine can only be obtained with a prescription.

How is Inovelon used?

Treatment with Inovelon should be started by a pediatrician or neurologist (a doctor who specializes in treating disorders of the nervous system) with experience in treating epilepsy.
The dose of Inovelon depends on the age and weight of the patient as well as on any concomitant intake of valproate (another antiepileptic drug). Treatment usually starts with a daily dose of 200 or 400 mg, which is then adjusted according to the patient's response.
Inovelon should be taken with water and food twice a day, in the morning and in the evening. If the patient has difficulty swallowing, the tablets can be crushed and mixed in a glass of water. Inovelon should be used with caution in people with liver problems. For more information, see the package leaflet.

How does Inovelon work?

The active substance in Inovelon, rufinamide, is an antiepileptic drug. It works by adhering to special channels on the surface of nerve cells in the brain (so-called sodium channels) that control the electrical activity of the cells. By adhering to these channels, rufinamide prevents them from going from a state of inactivity to a state of activity. In this way the activity of nerve cells
is reduced and it is therefore possible to prevent the spread to the brain of an "excessive electrical activity, decreasing the likelihood of seizures occurring.

How has Inovelon been studied?

The effects of Inovelon were first tested in experimental models before being studied in humans.
The main study of Inovelon involved 139 patients between the ages of 4 and 30, of which three-quarters were under the age of 17. All patients had uncontrolled Lennox-Gastaut syndrome despite receiving continuous treatment for at least 4 weeks with other antiepileptic drugs (1 to 3). The study compared the effects of Inovelon versus placebo (a substance with no effects on the body) as an adjunct therapy combined with other drugs taken by the patients. The main parameters of effectiveness were the change in the number of seizures in the 4 weeks following administration. of Inovelon or placebo compared to 4 weeks prior to the addition of such therapy, as well as the change in seizure severity based on the assessment made by the parent or guardian on a 7-point scale.

What benefit has Inovelon shown during the studies?

Inovelon has seen a reduction in the number and severity of crises. Patients who took Inovelon reported a 35.8% reduction in the total number of seizures compared to an average of 290 seizures in the 4 weeks prior to starting Inovelon treatment. "1.6%.
Patients who took Inovelon also reported a 42.5% decrease in the number of "tonic-atonic" seizures (a type of seizure common in Lennox-Gastaut syndrome patients, characterized by easy falls to the ground) compared to "increase of" 1.9% observed in patients treated with placebo.
About half of the patients taking Inovelon experienced improvement in seizure severity compared with a third of those taking placebo.

What are the risks associated with Inovelon?

The most common side effects with Inovelon (seen in more than 1 in 10 patients) are sleepiness, headache, dizziness, nausea, vomiting and fatigue. For the full list of side effects reported with Inovelon, see the package leaflet.
Inovelon must not be used in people who are hypersensitive (allergic) to rufinamide, derived from triazole (such as some medicines used to treat fungal infections) or to any of the other ingredients.

Why has Inovelon been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Inovelon's benefits are greater than its risks for the treatment, as add-on therapy, of the seizures associated with Lennox-Gastaut syndrome in patients aged 4 years and older, and it therefore recommended the issuing of the marketing authorization.

What measures are being taken to ensure the safe use of Inovelon?

The company that makes Inovelon will closely monitor the safety of the medicine. This monitoring also includes the observation of cases of "status epilepticus", a dangerous condition in which the brain is in a continuous state of crisis. This is due to the fact that cases of this type have been observed in subjects who have taken Inovelon. in the course of its development.

Other information about Inovelon:

On January 16, 2007, the European Commission granted Eisai Limited a "Marketing Authorization" for Inovelon, valid throughout the European Union.
The summary of the opinion of the Committee for Orphan Medicinal Products on Inovelon is available here.
For the full version of the evaluation (EPAR) of Inovelon, click here.

Last update of this summary: 01-2007.

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