What is it?

RILUTEK is a medicine containing the active substance riluzole. It is available as white, capsule-shaped 50 mg tablets.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS). ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis. RILUTEK is used to extend the patient?s life, or the time before they need to use mechanical ventilation.
RILUTEK should not be used in patients with any other form of motor neurone disease. The medicine can only be obtained with a prescription.

How is it used?

Treatment with RILUTEK should only be started by a specialist doctor with experience in the management of motor neurone diseases. In adult and elderly patients, it is given as 100 mg a day (50 mg every 12 hours). RILUTEK is not recommended for children or patients with kidney disease and should not be given to patients with liver disease. For more information please see the Package Leaflet.

How does it work?

The active substance in RILUTEK, riluzole, acts on the nervous system. The exact way in which it works in ALS is not known. It is thought that the destruction of nerve cells in motor neurone disease may be caused by too much glutamate, a neurotransmitter (chemical messenger). Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged.

How has it been studied?

The effectiveness of RILUTEK has been compared with that of placebo (a dummy treatment) in three studies involving a total of 1,282 patients. One of these studies was in older patients (over 75) and in patients with advanced disease. Across the studies, RILUTEK was given as 50, 100 or 200 mg per day, and for up to 18 months. The main measure of effectiveness was the average survival time.

What benefits has it shown during the studies?

The average survival time was significantly longer for patients who received RILUTEK compared with patients who received placebo. Looking at the results of the three studies together, over 18 months, patients who received RILUTEK 100 mg/day had an average survival time that was about 2 months longer than the survival time for patients who received placebo. RILUTEK 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day. The medicine was not more effective than placebo in the late stages of ALS.

What is the risk associated?

The most common side effects seen with RILUTEK (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests (increased in liver enzymes levels). For the full list of all side effects reported with RILUTEK, see the Package Leaflet.
RILUTEK should not be used in people who may be hypersensitive (allergic) to riluzole or any of the other ingredients. RILUTEK should not be used in patients who have liver disease or who have abnormally high levels of liver enzymes. RILUTEK should also not be given to women who are pregnant or breast-feeding.

Why has it been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that RILUTEK?s benefits are greater than its risks to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis. They noted that there is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms, and that it has not been shown to be effective in the late stages of ALS. The committee recommended that RILUTEK be given marketing authorisation.

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