Frequently Asked Questions about ALS and Rilutek (Riluzole)
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
stops the messages from getting through to the muscles, making it difficult to move.
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.
The active ingredient in Rilutek is riluzole (pronounced rill-you-zole).
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 those on placebo. Rilutek is not a cure for ALS, and it cannot give back physical
function that is already lost.
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.
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, seek medical attention immediately.
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.
Rilutek may cause you to feel dizzy, have vertigo (lightheadedness), or feel sleepy.
If you experience any of these, you should NOT drive a vehicle or use machinery.
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.
There is no information currently available on the combination of Rilutek with these
types of investigational drugs. You should discuss this with your doctor.
This decision should be made with your doctor. In clinical trials, Rilutek was shown
to be safe during 18 months of continuous treatment.
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.
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.
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.