Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Sanofi Mature IP, 54 rue La Boétie, 75008, Paris, France
RILUTEK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Clinical trials have demonstrated that RILUTEK extends survival for patients with ALS (see section 5.1). Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.
There is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. RILUTEK has not been shown to be effective in the late stages of ALS.
Safety and efficacy of RILUTEK has only been studied in ALS. Therefore, RILUTEK should not be used in patients with any other form of motor neurone disease.
Treatment with RILUTEK should only be initiated by specialist physicians with experience in the management of motor neurone diseases.
The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours). No significant increased benefit can be expected from higher daily doses.
RILUTEK is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Based on pharmacokinetic data, there are no special instructions for the use of RILUTEK in this population.
See sections 4.3, 4.4 and 5.2.
RILUTEK is not recommended for use in paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Oral use.
Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and methaemoglobinaemia have been observed in isolated cases.
In case of overdose, treatment is symptomatic and supportive.
3 years.
This medicinal product does not require any special storage conditions.
Tablets are packaged in opaque pvc/aluminium blister cards.
Each package contains 56 tablets.
No special requirements.
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