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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.
What is ALS (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?
Are there any other considerations?
Questions about the RILUTEK Care Connection Program
Why are you calling me periodically?
Why should I join?
What will you do?
How will I know RILUTEK is working?
Will this cure my ALS?
How much does it cost?
I don’t have any goals. I don’t know what I’d like to do?
Why can I not use the Discount Card with Medicare/Medicaid?
Why are Massachusetts patients not eligible?
What information may be shared with sanofi-aventis?
What is ALS (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 stops the messages from getting through to the muscles, making
it difficult to move.
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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 or time to
tracheostomy 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.
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What is RILUTEK made of?
The active ingredient in RILUTEK is riluzole (pronounced rill-you-zole).
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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
(survival defined as time to death or
tracheostomy) 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.
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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.
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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 be realized
by maintaining a consistent dosing schedule. Taking your medication every day is
a key to successful therapy.
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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.
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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 (not associated
with a reduction in vital capacity), headache, nasal symptoms, muscle tightness,
abdominal pain and high blood pressure. 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. Also,
call your doctor if you experience cough or difficulty breathing.
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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.
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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.
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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.
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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.
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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.
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Is there anything I should avoid?
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.
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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.
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Why are you calling me periodically?
The program incorporates periodic reminder calls to help you remember to fill your
prescription and use your savings card. We also want to remind you of important
things you have planned and to help you remain on therapy.
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Why should I join?
The RILUTEK Care Connection is here to help. You have the opportunity to receive
savings on your prescription and have access to helpful resources that will help
you get information when you need it and stay on therapy as directed.
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What will you do?
While you’re participating in the RILUTEK Care Connection program a trained representative
will be calling periodically to ensure that you’ve received your RILUTEK prescription
and help you keep track of your goals.
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How will I know RILUTEK is working?
Your healthcare professional is the best person to answer your medical questions.
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Will this cure my ALS?
No, there is no known cure for ALS. Your healthcare professional is the best person
to answer your medical questions.
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How much does it cost?
RILUTEK is covered by most private and government insurance plans. The out-of-pocket
cost for the medication will vary depending on the type of prescription coverage
you have. If you are having trouble paying for the product, we can help to see if
you qualify for patient assistance.
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I don’t have any goals. I don’t know what I’d like to do?
Is there an activity you enjoy or something you would like to accomplish while you
can still get around without help? Goals are good for you to have so you can make
the best use of your time.
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Why can I not use the Discount Card with Medicare/Medicaid?
Medicare and Medicaid are federally funded benefit programs that offer prescription
coverage at free or reduced costs. You are not eligible to receive additional savings.
This prescription discount program is for patients that have private insurance or
no insurance.
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Why are Massachusetts patients not eligible?
Massachusetts state law does not allow patients to receive prescription coverage
savings using a discount card of this kind.
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What information may be shared with sanofi-aventis?
Information such as the date your prescription was filled, quantity of pills dispensed,
as well as the amount of reimbursement by sanofi-aventis under the RILUTEK Cost
Reduction Card program. Your personally identifiable information will not be shared.
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