Teglutik (Riluzole) 5 mg/ml oral suspension, 300 ml: profile, composition and research

Reference page for Teglutik (Riluzole) 5 mg/ml oral suspension, 300 ml. Active substance: Рилузол / Riluzole.

Key facts

What riluzole is

Riluzole is a substance used in amyotrophic lateral sclerosis (ALS). This is a rare disease in which motor neurons gradually die and the person loses the ability to control muscles. Teglutik contains riluzole as an oral suspension with a strength of 5 mg/ml and a bottle volume of 300 ml.

Besides riluzole, the suspension contains sorbitol (E420) as an excipient. That matters for patients who cannot tolerate sorbitol, which is why the composition is listed separately in the prescribing information.

The medicine is prescription-only and is given only by the physician who manages a patient with motor neuron disease.

Mechanism and research data

The proposed mechanism

The exact mechanism of riluzole has not been established. Glutamate, the main excitatory neurotransmitter of the central nervous system, is thought to play a role in ALS. Riluzole suppresses processes linked to glutamate and thereby reduces damage to neurons.

What the trials showed

In placebo-controlled studies riluzole increased survival or the time to mechanical ventilation in patients with ALS. In one trial, median survival was 17.7 months on riluzole against 14.9 months on placebo.

What the drug does not do

An effect on muscle strength, lung function or individual symptoms has not been confirmed. In the late stage of the disease no benefit has been shown. The data come from ALS only, so the drug is not used in other forms of motor neuron disease.

Approved uses

The only indication in the prescribing information is to extend survival or the time to mechanical ventilation in patients with amyotrophic lateral sclerosis. ATC code: N07XX02.

Treatment is long-term and needs medical supervision. Riluzole can affect the liver and blood cells, so liver parameters and blood counts are checked before and during treatment.

The pack

Teglutik is an oral suspension with 5 mg of riluzole in 1 ml, in a 300 ml bottle. The dose and the way it is taken are set by a physician; the medicine is dispensed on prescription.

The suspension can be taken by mouth and can also be given through a feeding tube. The pack includes a graduated syringe for measuring.

Published research

Primary sources, verified against PubMed:

• Riluzole for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND)., PubMed 22419278 (Cochrane Database Syst Rev, 2012).
• A controlled trial of riluzole in amyotrophic lateral sclerosis. ALS/Riluzole Study Group., PubMed 8302340 (N Engl J Med, 1994).
• Riluzole for the treatment of amyotrophic lateral sclerosis., PubMed 32847483 (Neurodegener Dis Manag, 2020).

Listed for reference. Publication of a study is not a claim about this particular product.

Precautions

• This is a prescription medicine. Prescribing and monitoring belong to a physician.
• Riluzole can affect the liver. Liver parameters are checked before and during treatment, and the drug is stopped if they rise significantly.
• White-cell counts may fall. Any raised temperature during treatment should be reported to a doctor.
• Cases of lung damage have been reported with riluzole. Shortness of breath or a cough needs medical assessment.
• Use during pregnancy or breastfeeding is discussed with a doctor individually.
• Tell your doctor about every other medicine you take: interactions are possible.

Frequently asked