Pronunciation:

RIL-ue-zole

Brand Names:

• Exservan
• Rilutek
• Tiglutik

Dosage Forms:

• Suspension
• Tablet

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Glutamate Antagonist

Uses of This Medicine:

Riluzole is used to treat patients with amyotrophic lateral sclerosis (ALS), which is also known as Lou Gehrig's disease. Riluzole is not a cure for ALS, but it may extend survival for patients in the early stages of the disease or extend the time until a tracheostomy (breathing tube in the throat) is needed.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of riluzole in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of riluzole in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution and an adjustment in the dose for patients receiving riluzole.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Azathioprine
• Capmatinib
• Carbamazepine
• Levoketoconazole
• Mercaptopurine
• Methotrexate
• Pixantrone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (eg, neutropenia) or
• Liver disease, recent or history of or
• Lung disease (eg, interstitial lung disease)—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Place the oral film on top of the tongue one at a time. The film will stick to the tongue and begin to dissolve. Do not cut or split it. Do not take it with liquids. Do not talk, chew, or spit while the film dissolves.

Swallow the tablet whole. Do not break, crush, or chew it.

If you are using the oral liquid:

• This medicine can be taken by the mouth or be given via PEG tubes.
• Measure the oral liquid with the oral syringe that it comes with. Gently shake the oral liquid for at least 30 seconds before using it.
• Your doctor will give you certain instructions on how to take this medicine through a tube.

This medicine should be taken on an empty stomach. Take it at least 1 hour before or 2 hours after meals.

This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day (eg, in the morning and in the evening) and do not miss any doses.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (film, suspension, tablets):
  • For ALS:
    • Adults—50 milligrams (mg) (10 milliliters [mL]) 2 times a day (every 12 hours).
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Tablet: Skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused liquid after 15 days of opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have a rash, stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Riluzole can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor right away if you start having breathing problems, dry cough, chest pain, fever, or chills. These could be symptoms of a serious lung problem.

Tell your doctor if you have Japanese ancestry. You may need a lower dose of this medicine to avoid unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bladder pain

bloody or cloudy urine

blurred vision

chills

cough

dark urine

diarrhea

difficult, burning, or painful urination

fast, pounding, or irregular heartbeat or pulse

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

increased cough

itching skin

joint pain

loss of appetite

lower back or side pain

muscle aches and pains

nausea

nervousness

persistent loss of appetite or weight loss

pounding in the ears

right upper quadrant tenderness

runny nose

shivering

slow heartbeat

sore throat

trouble sleeping

unusual tiredness or weakness

vomiting

yellow eyes or skin

Incidence not known

Black, tarry, stools

decreased frequency or amount of urine

difficult breathing

increased thirst

nausea

pale skin

swelling of the face, fingers, or lower legs

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

back pain

bluish-colored lips, fingernails, or palms

blurred vision

coma

confusion

dark urine

difficulty breathing

dizziness or lightheadedness

drowsiness

fever

headache

irritability

memory loss

pale skin

rapid heart rate

seeing, hearing, or feeling things that are not there

seizures

sore throat

stiff neck

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

lack or loss of strength

Less common

Difficulty moving

dizziness or lightheadedness

dry mouth

excess air or gas in the stomach or bowels

feeling of constant movement of self or surroundings

full feeling

muscle stiffness

passing gas

rapid weight gain

sensation of spinning

skin rash, encrusted, scaly and oozing

sleepiness or unusual drowsiness

stomach pain

tingling of the hands or feet

unusual weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.