What is RILUTEK?
RILUTEK is a medicine containing the active substance riluzole, available as white, capsule-shaped tablets of 50 mg.
What is RILUTEK used for?
RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS). ALS is a form of motor neuron disease, in which a progressive degeneration of the nerve cells responsible for sending instructions to the muscles is observed, resulting in the onset of weakening, muscle atrophy and paralysis. RILUTEK is indicated to prolong the patient's life or to delay the use of assisted ventilation.
The use of RILUTEK is not recommended in patients with any other form of motor neuron disease.
The medicine can only be obtained with a prescription.
How is RILUTEK used?
Treatment with RILUTEK should be started by medical specialists with experience in the treatment of motor neuron diseases. In adults or the elderly the recommended daily dose is 100 mg (50 mg every 12 hours). RILUTEK is not recommended for the treatment of children or patients with reduced kidney function and should not be given to patients with liver disease. For more information, see the package leaflet.
How does RILUTEK work?
The active substance in RILUTEK, riluzole, acts on the nervous system. The exact mechanism of action in ALS is not known. However, it is hypothesized that in this pathology the destruction of nerve cells can be caused by an excessive rate of glutamate, a neurotransmitter (chemical messenger). Riluzole is believed to inhibit the release of glutamate and thus help prevent damage to nerve cells.
How has RILUTEK been studied?
The efficacy of RILUTEK was compared with that of placebo (an ineffective substance on the body) in three studies involving a total of 1 282 patients. One of these studies was carried out on elderly patients (over 75 years) and in subjects at an advanced stage of the disease. In these studies RILUTEK was given at a dose of 50, 100 or 200 mg a day, for a period not exceeding 18 months. The main measure of effectiveness was the average survival time.
What benefit has RILUTEK shown during the studies?
The average survival time was significantly greater in patients treated with RILUTEK compared to subjects treated with placebo. Considering the results of the three studies as a whole, in the space of 18 months patients taking RILUTEK 100 mg / day showed an average survival time that was about 2 months longer than the survival time of subjects treated with placebo. RILUTEK 50 mg / day was not more effective than placebo, while the 200 mg / day dose was not more effective than the 100 mg / day dose. In the final stages of ALS the medicine did not show superior efficacy to placebo.
What is the risk associated with RILUTEK?
The most common side effects seen with RILUTEK (in more than 1 in 10 patients) are nausea, asthenia (decreased strength) and increased liver function parameters (increased levels of liver enzymes). 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 substances. RILUTEK should not be used in patients with liver disease or above normal liver enzyme levels. RILUTEK should also not be used during pregnancy or breastfeeding.
Why has RILUTEK been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of RILUTEK outweigh the risks to prolong life or postpone the use of assisted ventilation in patients with amyotrophic lateral sclerosis. The committee noted that there is no evidence that RILUTEK has a therapeutic effect on the functioning of the musculoskeletal system, pulmonary function, fasciculations (involuntary muscle contractions), muscle strength and motor symptoms; also noted that the medicine is not effective in the final stages of ALS. The committee recommended the granting of RILUTEK marketing authorization.
More information about RILUTEK:
On 10 June 1996 the European Commission granted a marketing authorization for RILUTEK to Aventis Pharma SA, valid throughout the European Union. The marketing authorization was renewed on 10 June 2006.
The full EPAR for RILUTEK can be found here.
Last update of this summary: 03-2007
