Exservan (Oral)

Riluzole is used to treat patients with amyotrophic lateral sclerosis (ALS), also called Lou Gehrig's disease. Riluzole does not cure ALS, but it may help patients in the early stages of the disease live longer or delay the need for a tracheostomy (breathing tube in the throat).

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

It is very important that your doctor checks your progress at regular visits to ensure 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 reduce the number of white blood cells in your blood, increasing the chance of getting an infection. If possible, 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.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important things to consider for this medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how riluzole affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies to date have not found specific problems in elderly patients that would limit the usefulness of riluzole. However, older adults are more likely to have liver problems related to age, which may require caution and a dose adjustment for those taking riluzole.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to change the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Abametapir
• Capmatinib
• Levoketoconazole
• Methotrexate
• Pixantrone

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant 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 frequency of this medicine, or give you special instructions regarding food, alcohol, or tobacco.

• Tobacco

Other Medical Problems

Other medical problems may affect how this medicine works. Be sure to tell your doctor if you have any other medical issues, especially:

• Bone marrow problems (e.g., neutropenia) or
• Liver disease, recent or past or
• Lung disease (e.g., interstitial lung disease)—Use with caution. May worsen these conditions.

• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

Along with its benefits, this medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical help.

Check with your doctor right away if you notice any of these side effects:

Less common

• Bladder pain
• Bloody or cloudy urine
• Blurred vision
• Chills
• Cough
• Dark urine
• Diarrhea
• Painful, burning, or difficult urination
• Fast, pounding, or irregular heartbeat or pulse
• Fever
• Frequent urge to urinate
• General feeling of discomfort or illness
• Headache
• Increased cough
• Itchy skin
• Joint pain
• Loss of appetite
• Lower back or side pain
• Muscle aches and pains
• Nausea
• Nervousness
• Ongoing loss of appetite or weight loss
• Pounding in the ears
• Tenderness in the right upper quadrant
• 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
• Trouble breathing
• Increased thirst
• Nausea
• Pale skin
• Swelling of the face, fingers, or lower legs
• Mouth ulcers, sores, or white spots
• Unusual bleeding or bruising
• Weight gain

Get emergency help immediately if you have any of these symptoms of overdose:

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
• Hallucinations
• Seizures
• Sore throat
• Stiff neck
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting

Some side effects may happen that usually do not need medical attention. These side effects may go away as your body gets used to the medicine. Your healthcare professional may also have ways to help prevent or lessen some of these side effects. Talk to your healthcare professional if any of these side effects continue, are bothersome, or if you have 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 gas in the stomach or bowels
• Feeling like you or your surroundings are constantly moving
• Full feeling
• Muscle stiffness
• Passing gas
• Rapid weight gain
• Spinning sensation
• Skin rash that is encrusted, scaly, and oozing
• Sleepiness or unusual drowsiness
• Stomach pain
• Tingling in 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, talk to your healthcare professional.

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

In the U.S.

• Exservan
• Rilutek
• Tiglutik

Available Dosage Forms:

• Suspension
• Film
• Tablet

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Glutamate Antagonist

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.

• What is the difference between Rilutek, Tiglutik and Exservan?