Rilutek (riluzole)

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Rilutek (riluzole)

Rilutek (riluzole) is a medication used for the treatment of amyotrophic lateral sclerosis (ALS).

How to buy Rilutek (riluzole): You can order Rilutek (riluzole) from TheSocialMedwork if the drug has not been approved or is not available in your country. 

For this product the estimated delivery time can be as short as 5 working days depending on availability.

Neurology Amyotrophic Lateral Sclerosis (ALS)
Marketing Authorisation Holder Sanofi - Aventis Groupe
Mode of Action Glutamate release inhibitor
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 50 milligram
Package 56 Capsules

What is Rilutek (riluzole)?

Rilutek (riluzole) is a glutamate release inhibitor indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS)1,2,3.

How does Rilutek (riluzole) work?

It is still not clear how ALS develops, however it seems that the neurotransmitter glutamate plays a role in cell death. Although the exact mode of action is unclear, Rilutek (riluzole) is thought to inhibit the release of glutamate1.

Rilutek (riluzole) aims to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). There is no evidence that it has a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms1.

Where has Rilutek (riluzole) been approved?

Rilutek (riluzole) was approved for the treatment of patients with ALS by:

  • Food and Drug Administration (FDA), USA, December 12, 1995

  • European Medical Agency (EMA), European Union, June 10, 1996

  • Therapeutic Goods Administration (TGA), Australia, May 3, 2002

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Rilutek (riluzole) taken?

The standard dosage is1,2,3:

  • 1 tablet of 50 mg every 12 hours (total daily dose: 100 mg).


Complete information about Rilutek (riluzole) dosage and administration can be found in the official prescribing information listed in our resources section
1,2,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Rilutek (riluzole)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include1:

  • asthenia1,2 (Lack of energy and strength)

  • nausea1,2 (feeling sick)

  • dizziness2

  • decreased lung function2

  • abdominal pain2

  • abnormal liver function tests1.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1,2,3:

  • liver injury

  • neutropenia (low white blood cells count)

  • interstitial lung disease.

Use in specific populations

Rilutek (riluzole) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.


For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2,3.

More Information
Working ingredient riluzole
Shipping method Standard (not temperature controlled)
Package 56
Therapeutic Area Neurology
Neurology Amyotrophic Lateral Sclerosis (ALS)
Indication Amyotrophic Lateral Sclerosis (ALS)
Administration Oral
Mode of Action Glutamate release inhibitor
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Sanofi - Aventis Groupe

The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia) approvals of Rilutek (riluzole) for ALS were based on two main multicentre, double-blind studies. The first study involved 155 patients who were randomly divided into two groups and were given either placebo or riluzole 50 mg twice per day. The second study involved 959 patients who were randomly assigned to one of four treatment groups: riluzole 50, 100, 200 mg/day, or placebo1,2,3. Patients in both studies had either familial or sporadic ALS, a disease duration of less than 5 years, and a baseline forced vital capacity greater than or equal to 60% of normal2.

Another study investigated the efficacy of Rilutek (riluzole) in patients at a late stage of the disease (vital capacity less than 60%). In this study survival time and motor function under riluzole did not differ significantly from that of placebo1.

Results

The main efficacy outcome measure was the median survival time.

Rilutek (riluzole) improved survival in both studies, however, measures of muscle strength and neurological function did not show a benefit2.

The median survival time was1,2,3:

  • 17.7 months with riluzole 100 mg/day vs 14.9 months with placebo in the 1st study

  • 16.5 months with riluzole 100 mg/day vs. 13.5 months with placebo in the 2nd study

    • the effect of riluzole 50 mg/day was not significant

    • the effect of riluzole 200 mg/day was comparable to the lower dosage of 100 mg/day.

  1. Summary of Product Characteristics [EMA]: Rilutek (riluzole) [PDF],
    Aventis Pharma, January 2018.

  2. Summary of Product Characteristics [FDA]: Rilutek (riluzole) [PDF],
    Covis Pharmaceuticals, April 2016.

  3. Summary of Product Characteristics [TGA]: Rilutek (riluzole) [PDF],
    Sanofi-Aventis, January 2009.

Shipping Type Standard
Shipping method Standard (not temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.