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Important Treatment Considerations
FOR U.S. RESIDENTS ONLY
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For people with ALS, from the start, prescribe Rilutek

Sanofi-aventis Patient Assistance Program

Sanofi-aventis, makers of Rilutek® (riluzole) tablets, is committed to helping patients with ALS and their caregivers, and provides them with 2 patient assistance programs:

The Rilutek Continuity Program

  • 1-800-RILUTEK
  • Provides ALS patients with the following free services:
    • Complete pharmacy services.
    • Assistance with insurance forms and claims, including job loss or change.
    • Electronic claims processing where permitted by the plan.
    • Advocacy if claim is delayed, denied, or sent to a case manager.
    • Assistance with accessing federal and state payment programs.
    • Referral to the Rilutek Patient Assistance Program.

The Rilutek Patient Assistance Program

  • Provides an equal opportunity for ALS patients to receive treatment
  • Has helped to cover the cost of Rilutek for hundreds of eligible patients
  • The program is sponsored by sanofi-aventis and is administered by the National Organization for Rare Disorders (NORD)
  • Eligibility is determined solely by medical and financial criteria. All eligibility decisions are made by NORD

Logon to www.sanofi-aventis.com for more information about the company’s creativity and innovation in patient health.

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Important Treatment Considerations

  • Evaluate serum ALT levels every month during the first 3 months of treatment, and every 3 months during the remainder of the first year. Thereafter, serum ALT levels should be periodically evaluated more frequently in patients who develop elevations. Rilutek should be discontinued if ALT levels increase to 5 times ULN or if clinical jaundice develops.
  • 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.
  • Use Rilutek with caution in patients with concomitant liver insufficiency; caution should be exercised when prescribing Rilutek to patients taking drugs that are potentially hepatotoxic or highly protein bound:
    • Interactions may also occur when riluzole is given concurrently with agents that affect hepatic CYP 1A2 activity.*
*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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US.RIL.07.07.001 Last Update: May 2007