What is Rilutek (riluzole) for?

Rilutek (riluzole) is a medication used to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. It helps slow down the progression of the disease by reducing the amount of glutamate, a chemical in the brain that can contribute to nerve damage in ALS.

How does Rilutek (riluzole) work?

Rilutek (riluzole) works by reducing the amount of glutamate, a neurotransmitter in the brain that is believed to be involved in the degeneration of motor neurons in amyotrophic lateral sclerosis (ALS). By decreasing the amount of glutamate, Rilutek may slow down the progression of ALS and improve the patient’s quality of life. Rilutek also has other mechanisms of action, such as enhancing the activity of certain neurotransmitters and reducing oxidative stress, which may contribute to its neuroprotective effects. However, the exact mechanisms underlying Rilutek’s effects on ALS are not fully understood.

How is Rilutek (riluzole) taken?

Rilutek (riluzole) is typically taken orally in the form of tablets. The usual recommended dose is 50 mg twice daily, taken at least one hour before or two hours after a meal. Rilutek tablets should be swallowed whole with a glass of water, and should not be crushed or chewed. Patients are advised to follow the dosing instructions carefully, and not to stop or change the dose of Rilutek without consulting with their healthcare provider first. Some patients may require dose adjustments based on their individual needs and response to treatment.

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

Yes, there are some known side effects of Rilutek (riluzole), which can affect a small percentage of patients. The most common side effects of Rilutek include:

– Nausea
– Dizziness
– Stomach upset or pain
– Weakness or fatigue
– Headache
– Altered sense of taste

Some less common side effects include:

– Liver problems
– Allergic reactions
– Respiratory problems
– Blood abnormalities
– Worsening of depression or anxiety

Patients are advised to inform their healthcare provider if they experience any side effects while taking Rilutek, as some side effects may require immediate medical attention. Furthermore, patients should take Rilutek only under medical supervision and as directed to minimize the risk of adverse effects.

Clinical trials

The approval of Rilutek (riluzole) for ALS by regulatory agencies such as the FDA, EMA, EU, and TGA was based on two major multicenter, double-blind studies. In the first study, 155 patients with familial or sporadic ALS were randomly assigned to receive either placebo or Rilutek 50 mg twice daily. The second study involved 959 patients who were randomly assigned to one of four treatment groups: Rilutek 50, 100, or 200 mg/day, or placebo. Patients in both studies had a disease duration of less than 5 years and a baseline forced vital capacity greater than or equal to 60% of normal.

In a study of patients in a late stage of the disease, Rilutek did not significantly improve survival time or motor function compared to placebo.

The main efficacy outcome measure was the median survival time, which was improved by Rilutek in both studies. However, measures of muscle strength and neurological function did not demonstrate a significant benefit. The median survival time with Rilutek 100 mg/day was 17.7 months in the first study and 16.5 months in the second study, compared to 14.9 and 13.5 months with placebo, respectively. The effect of Rilutek 50 mg/day was not significant, and the effect of Rilutek 200 mg/day was comparable to the lower dosage of 100 mg/day.