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.

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