Rilutek

The active ingredient in Rilutek is riluzole, which is a glutamate antagonist. The mechanism of action involves reducing the quantity of a molecule called glutamate released in the body. We don't know exactly what causes ALS, but it's assumed to be nerve damage caused by excessive glutamate levels in the nervous system (brain and spinal cord). Rilutek slows nerve damage and the worsening of ALS symptoms, such as muscle weakness, by lowering the amount of glutamate released in the body.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Rilutek. However, the following is a synopsis of the general guidelines for the use of Rilutek:

• Take Rilutek on an empty stomach, at least 1 hour before or 2 hours after eating.
• Rilutek can also be administered using a PEG feeding tube.
• Shake the oral suspension for at least 30 seconds before measuring a dose. Use the included dosing syringe or a pharmaceutical dose-measuring instrument (not a kitchen spoon).
• You will require frequent medical examinations.

The most common side effects of riluzole seen in clinical trials as compared to placebo include:

• Drowsiness.
• Abdominal pain.
• High blood pressure.
• Mouth numbness.
• Shortness of breath.
• Decreased lung function.
• Weakness or asthenia.
• Dry mouth.

Some individuals may experience serious side effects while using Rilutek. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Liver disease or liver injury: stomach pain, black urine, and yellowing of the skin or eyes.
• Low white blood cell counts: frequent infections, fevers, or sore throats, as well as excessive fatigue.
• Breathing difficulties: dry cough, rapid or shallow breathing, and shortness of breath.
• Allergic reactions: hives, skin rash, and adverse reactions to the body.

Disclaimer: These are not all of the possible side effects of Rilutek. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Rilutek, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Liver disease, impairment, or high levels of liver enzymes.
• Bone marrow problems (eg, neutropenia).
• A current infection.
• Lung disease (e.g., interstitial lung disease).

Rilutek is contraindicated in patients who have had severe hypersensitivity responses to riluzole or any of its inactive ingredients.

There is no specific time frame for how long it takes Rilutek to work. It has been shown to increase your life expectancy if you have ALS.

When Rilutek is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Inhibitors of CYP 1A2 (e.g., caffeine, phenacetin, theophylline, amitriptyline, and quinolones).
• Inducers of CYP 1A2 (e.g., cigarette smoke, charcoal-broiled food, rifampicin, and omeprazole).

The normal dose is one 50 mg tablet, film-coated, taken orally every 12 hours.

Riluzole (Rilutek) is also available in liquid form under the brand name Tiglutik and as an oral film under the brand name Exservan.

If you miss a dose, take the missed dose as soon as possible, but omit it if it's almost time for the next dose. Do not take two doses at the same time.

Store your Rilutek at room temperature and out of reach of children.

Sanofi Winthrop is the pharmaceutical company that manufactures Rilutek.

There are several lower-cost generic name versions available.

It is not recommended to stop taking this medication without consulting with your healthcare provider first.

There are no adequate and well-controlled studies of Rilutek use in pregnant women. It should only be used during pregnancy if the possible benefits outweigh the potential risks to your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant.

It is not recommended to breastfeed while taking Rilutek as the drug can pass into the breast milk and may affect your infant. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed.