Why Prescribe RILUTEK?
While no cure has been found yet for ALS, treatments and support are available. Research is ongoing to determine the mechanisms involved in disease progression and develop effective treatments. Today, treatment can provide survival benefits (2 to 3 months were seen in clinical trials).
RILUTEK is the first and only treatment proven to prolong survival of ALS patients and has been available for more than 14 years (survival defined as time to tracheostomy or death).1-5
Neuroprotective benefits1
The mechanism of action is unknown. RILUTEK may block glutamatergic transmission and its pharmacological properties may contribute to neuroprotection by1
- Inhibition of glutamate release1
- Inactivation of voltage-dependent sodium channels1
- Interference with damaging intracellular events following binding of excitatory neurotransmitters1
Survival benefits
Starting patients on RILUTEK may extend survival time. Two (N=1114), double-blind, placebo-controlled studies demonstrated that RILUTEK extended survival time and/or time to tracheostomy in patients with ALS.1,2,3
- RILUTEK significantly improved tracheostomy-free survival 1,2,3
- A 2- to 3-month increase in median survival time (survival defined as time until tracheostomy or death) was observed in the RILUTEK arm vs the placebo arm1,2
- Patients treated with RILUTEK 100 mg/day had a higher survival probability than those in the placebo arm1,2,3
- There was no statistically significant difference at the end of the 18-month study period1
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.
