For U.S. Residents Only
ALS Glossary
Amyotrophic lateral sclerosis (ALS):
A disease of the central nervous system that disrupts the way the brain sends messages to certain muscles, including those used for breathing and swallowing. The disorder causes muscle weakness. As the disease progresses, ALS makes it difficult, and often impossible, to move these muscles. The cause is unknown, and there is no known cure.Anesthesia:
Drug-induced loss of sensation to avoid pain.Atrophy:
The wasting or loss of muscle tissue, typically due to nerve damage in ALS patients.Biopsy:
An invasive medical test that removes tissue from the body to examine it under a microscope.Bilevel Positive Airway Pressure (BiPAP):
A device that artificially inflates the lungs and may be used to help a patient breathe.Central nervous system:
The body's "communication network," made up of the brain and spinal cord.Electromyography (EMG):
A noninvasive medical test used to evaluate and diagnose disorders of the muscles and motor neurons. Electrodes are inserted into the muscle, or placed on the skin overlying a muscle or muscle group, and electrical activity and muscle response are recorded.Intermittent Positive Pressure Ventilation (IPPV):
A device that artificially inflates the lungs and may be used to help a patient breathe.Invasive ventilation:
A tracheostomy where a tube is placed through the neck into the main breathing pathway. This will provide more efficient ventilation and better control of the upper airway and secretions.Lou Gehrig:
A famous Yankees first baseman from the 1940s who developed ALS. ALS is also referred to as "Lou Gehrig's Disease".Magnetic resonance imaging (MRI):
A noninvasive procedure that produces a high-contrast, two-dimensional view of an internal organ or structure, typically of the brain and spinal cord.Mechanical ventilation:
A machine that inflates and deflates the lungs to help with breathing.Motor neurons:
Nerve cells of the central nervous system that act as messengers between the brain and muscle tissue.Muscle:
The tissue of the body which primarily functions as a source of power. There are three types of muscle in the body. Muscle that moves extremities and external areas of the body is called "skeletal muscle." The heart muscle is called "cardiac muscle." And muscle in the walls of arteries and the bowel is called "smooth muscle.".Muscle cramps:
Involuntary, painful shortening of muscles.Muscle weakness:
Loss of muscle strength with increased fatigue, loss of coordination, and difficulty with motor skills.Neurologist:
A doctor who specializes in the diagnosis and treatment of disorders in the central, peripheral, and autonomic nervous system.Non-invasive:
A procedure for diagnosis or treatment that does not require surgery.Noninvasive ventilation:
A type of respiratory support where different levels of pressure are applied to the lungs during inspiration and expiration in order to stimulate patient breathing. It assists with the patient's own breathing but does not replace their effort. Also known as BiPAP.Physical examination:
A thorough assessment of a patient's physical condition to collect information for diagnosis.Placebo:
A pill without medicine in it, given to people in clinical trials as a "control".Trachea:
The windpipe that leads from the mouth to the lungs.Tracheostomy:
A surgical operation where a plastic breathing tube is inserted through a hole created in a patient's windpipe to allow access to a machine to help with breathing.Important Safety Information
- Serum aminotransferases including ALT levels should be measured before and during RILUTEK therapy. Evaluate serum ALT levels every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter; RILUTEK should be discontinued if ALT levels increase to 5 times ULN or if clinical jaundice develops. There is limited experience with rechallenge of patients who have had RILUTEK discontinued for ALT > 5 X ULN, but there is the possibility of increased ALT values reoccurring. Therefore, rechallenge is not recommended.
- Advise patients about the potential for dizziness, vertigo, or somnolence and not to drive or operate machinery until they have sufficient experience on RILUTEK.
- Advise patients to report any febrile illness; measure WBCs.
- Advise patients to report any cough or difficulty in breathing. Riluzole should be discontinued in cases of interstitial lung disease or hypersensitivity pneumonitis.
-
Use RILUTEK with caution in patients with concomitant hepatic or renal insufficiency; caution should be exercised when prescribing RILUTEK to patients taking drugs that are potentially hepatotoxic or highly protein bound; in postmarketing experience, cases of clinical hepatitis associated with riluzole have been reported, including with fatal outcome.
- Interactions may also occur when riluzole is given concurrently with agents that affect hepatic CYP 1A2 activity*.
- The most common (=5%) adverse events that occurred at higher rates in patients treated with RILUTEK vs placebo were: asthenia (19.2% vs 12.2%, respectively), nausea (16.3% vs 10.6%), lung function decrease (not associated with decreased vital capacity; 10.2% vs 9.4%), headache (7.3% vs 6.6%), rhinitis (6.4% vs 6.3%), hypertonia (6.1% vs 5.9%), abdominal pain (5.1% vs 3.8%), and hypertension (5.1% vs 4.1%).
Please refer to the full prescribing information using the link at the top of the page.
*Not associated with a reduction in vital capacity
Indication
RILUTEK is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Riluzole extends survival and/or time to tracheostomy.
Important Safety Information
- Serum aminotransferases including ALT levels should be measured before and during RILUTEK therapy. Evaluate serum ALT levels every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter; RILUTEK should be discontinued if ALT levels increase to 5 times ULN or if clinical jaundice develops. There is limited experience with rechallenge of patients who have had RILUTEK discontinued for ALT > 5 X ULN, but there is the possibility of increased ALT values reoccurring. Therefore, rechallenge is not recommended.
- Advise patients about the potential for dizziness, vertigo, or somnolence and not to drive or operate machinery until they have sufficient experience on RILUTEK.
- Advise patients to report any febrile illness; measure WBCs.
- Advise patients to report any cough or difficulty in breathing. Riluzole should be discontinued in cases of interstitial lung disease or hypersensitivity pneumonitis.
-
Use RILUTEK with caution in patients with concomitant hepatic or renal insufficiency; caution should be exercised when prescribing RILUTEK to patients taking drugs that are potentially hepatotoxic or highly protein bound; in postmarketing experience, cases of clinical hepatitis associated with riluzole have been reported, including with fatal outcome.
- Interactions may also occur when riluzole is given concurrently with agents that affect hepatic CYP 1A2 activity*.
- The most common (=5%) adverse events that occurred at higher rates in patients treated with RILUTEK vs placebo were: asthenia (19.2% vs 12.2%, respectively), nausea (16.3% vs 10.6%), lung function decrease (not associated with decreased vital capacity; 10.2% vs 9.4%), headache (7.3% vs 6.6%), rhinitis (6.4% vs 6.3%), hypertonia (6.1% vs 5.9%), abdominal pain (5.1% vs 3.8%), and hypertension (5.1% vs 4.1%).
*CYP 1A2 is the principal isoenzyme involved in the initial oxidative metabolism of riluzole. CYP 1A2 inhibitors, such as amitriptyline, caffeine, phenacetin, theophylline, or quinolones, may potentially decrease the rate of riluzole elimination. CYP 1A2 inducers, such as cigarette smoke, charcoal-broiled food, rifampicin, or omeprazole, may potentially increase the rate of elimination.
Please click here for Full Prescribing Information.
The health information contained herein is provided for general educational purposes only.
As a healthcare professional, you are the single best source of information regarding healthcare for your patients with ALS.
Please contact Sanofi if you have any questions or need more information about treating ALS.
