You may have questions about ALS or treatment with RILUTEK. The information here may help answer them. Your best resource for additional information is your doctor.

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What is ALS (also known as Lou Gehrig’s Disease)?

What are RILUTEK tablets, and how do they work?

What is RILUTEK made of?

What will RILUTEK do for me?

How can I tell if RILUTEK is working?

When should I take RILUTEK?

What should I do if I miss a dose of RILUTEK, or take more than prescribed by my doctor?

What are the side effects of RILUTEK?

Can I drive or use machines when taking RILUTEK?

Can I take other medications while taking RILUTEK?

Can I combine RILUTEK with other investigational drugs for ALS?

How long should I take RILUTEK tablets?

If I stop taking RILUTEK, will there be any side effects? What impact will stopping RILUTEK have on my condition?

Is there anything I should avoid while taking RILUTEK?

Are there any other considerations?

What is ALS (also known as Lou Gehrig's Disease)?

ALS stands for amyotrophic lateral sclerosis. It is a disease of the central nervous system that affects a person’s ability to move certain muscles.

The central nervous system is a complex network that sends messages from the brain, like muscle movement, to the rest of the body. These messages are carried by nerve cells called motor neurons. The motor neurons not only carry the messages, they do the “talking” for the brain and tell the muscles what to do. ALS increasingly prevents the messages from getting through to the muscles, making it difficult to move.

What are RILUTEK tablets, and how do they work?

RILUTEK is the first effective treatment for people with ALS. Although researchers don’t fully understand how RILUTEK works, one explanation is that RILUTEK may protect nerve cells from overexposure to a substance called glutamate. This protection could explain the effect of RILUTEK on extending the time of survival of people with ALS. Glutamate is a substance the body naturally makes that carries signals to the motor neurons. This is one link in the chain of how the brain tells the muscles what to do. Too much glutamate "burns out" the motor neurons so that they can’t carry the brain’s messages to the muscles in order for them to function.

What is RILUTEK made of?

The active ingredient in RILUTEK is riluzole (pronounced rill-you-zole).

What will RILUTEK do for me?

Over 1,100 patients have participated in clinical trials for RILUTEK. During the first year of treatment, patients who took RILUTEK had a better chance of survival compared to patients who took a placebo (sugar pill).

However, by the end of 18 months, there was no difference between the RILUTEK group and the placebo group. RILUTEK is not a cure for ALS, and it cannot give back physical function that is already lost.

How can I tell if RILUTEK is working?

No one knows exactly how RILUTEK works. Most likely, it works with chemicals in the body to protect motor neurons, the messengers that carry information from the brain to the muscles. You may not feel any different but that doesn’t mean RILUTEK isn’t working.

When should I take RILUTEK?

The recommended dose is one 50-mg tablet of RILUTEK every 12 hours. You should take RILUTEK on a regular basis and at the same time of the day (eg, in the morning and evening) every day, at least 1 hour before, or 2 hours after, a meal. It is very important that you take RILUTEK as prescribed. The benefit of RILUTEK can only be realized by maintaining a consistent dosing schedule.
Taking your medication every day is a key to successful therapy.

What should I do if I miss a dose of RILUTEK, or take more than prescribed by my doctor?

If you miss or skip a dose of RILUTEK, do not take any extra tablets to make up for those you missed, but take your prescribed dose at the next regularly scheduled time. There is no benefit to increasing the dose of RILUTEK above 2 tablets per day. On the contrary, you may encounter more side effects.

In case of an overdose, discontinue treatment and seek medical attention immediately.

What are the side effects of RILUTEK?

Medicines can sometimes cause unwanted effects known as side effects. The most common side effects of RILUTEK are weakness, nausea, lung function decrease*, a mild liver abnormality that is typically temporary, runny nose, and headache.

If any side effects become troublesome, contact your doctor. Although fever is not a side effect of RILUTEK, call your doctor if you develop one; your doctor may need to check your white blood cell count.

*Not associated with a reduction in vital capacity.

Can I drive or use machines when taking RILUTEK?

RILUTEK may cause you to feel dizzy, have vertigo (lightheadedness), or feel sleepy. If you experience any of these symptoms, you should NOT drive a vehicle or use machinery.

Can I take other medications while taking RILUTEK?

Since it is always possible that one drug will react negatively with another, you need to talk to your doctor before taking any medicines. This is especially important because no clinical studies have been done to test the interaction of RILUTEK with other drugs.

Be sure to tell your doctor and pharmacist about all other medicines you are taking, including nonprescription products and vitamins. Also, if you have to go to another doctor, dentist, or hospital for any reason, remember to tell the doctor or medical professional about all the medications you are taking, including RILUTEK.

Can I combine RILUTEK with other investigational drugs for ALS?

There is no information currently available on the combination of RILUTEK with these types of investigational drugs. You should discuss this with your doctor.

How long should I take RILUTEK tablets?

This decision should be made with your doctor. In clinical trials, RILUTEK was shown to be safe during 18 months of continuous treatment.

If I stop taking RILUTEK, will there be any side effects? What impact will stopping RILUTEK have on my condition?

There appear to be no side effects if you stop taking RILUTEK. However, researchers do not know if the effects of RILUTEK are continued after treatment is stopped.

Is there anything I should avoid while taking RILUTEK?

Of course, it is generally not recommended that you smoke or drink excessive amounts of alcohol, but this is particularly important for patients taking RILUTEK. Smoking can decrease the amount of RILUTEK in the blood. Alcohol can contribute to compromising liver function, and may be associated with an increased risk of liver problems with RILUTEK.

Are there any other considerations?

Before you take RILUTEK, it is important to tell your doctor if you have liver or kidney problems. While you are using RILUTEK, it is recommended that you have a blood test from time to time at your doctor’s discretion.

Blood tests are important because some people may experience a temporary, mild liver disorder. Depending on these test results, your doctor may need to evaluate your situation further. Call your doctor immediately if you have a fever or if you have an allergic reaction to RILUTEK. If you are pregnant, suspect you are pregnant, or are planning on becoming pregnant, you should not use RILUTEK without first discussing it with your doctor. Also, if you are breastfeeding or you plan to breastfeed, you should discuss this with your doctor before taking RILUTEK. Remember to store RILUTEK at room temperature (68° to 77°F) and protect it from bright light. Be sure to keep RILUTEK out of the reach of children.