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Basic Drug Info
Drug Name:Rilutek
Manufacturer:sanofi-aventis U.S. LLC
Other Info:

Revised November 2006sanofi-aventis U.S.

LLCBridgewater, NJ 08807© 2006 sanofi-aventis U.S.

LLC



Clinical Trials:


Indications and Usage

RILUTEK is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Riluzole extends survival and/or time to tracheostomy.
Amyotrophic Lateral Sclerosis -- A degenerative disorder affecting upper MOTOR NEURONS in the brain and lower motor neurons in the brain stem and SPINAL CORD. Disease onset is usually after the age of 50 and the process is usually fatal within 3 to 6 years. Clinical manifestations include progressive weakness, atrophy, FASCICULATION, hyperreflexia, DYSARTHRIA, dysphagia, and eventual paralysis of respiratory function. Pathologic features include the replacement of motor neurons with fibrous ASTROCYTES and atrophy of anterior SPINAL NERVE ROOTS and corticospinal tracts. (From Adams et al., Principles of Neurology, 6th ed, pp1089-94)

Contraindications
RILUTEK is contraindicated in patients who have a history of severe hypersensitivity reactions to riluzole or any of the tablet components.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

RILUTEK should be prescribed with care in patients with current evidence or history of abnormal liver function indicated by significant abnormalities in serum transaminase (ALT/SGPT; AST/SGOT), bilirubin, and/or gamma-glutamate transferase (GGT) levels (see PRECAUTIONS and DOSAGE AND ADMINISTRATION sections).

Baseline elevations of several LFTs (especially elevated bilirubin) should preclude the use of RILUTEK.RILUTEK, even in patients without a prior history of liver disease, causes serum aminotransferase elevations.

Experience in almost 800 ALS patients indicates that about 50% of riluzole-treated patients will experience at least one ALT/SGPT level above the upper limit of normal, about 8% will have elevations > 3 × ULN, and about 2% of patients will have elevations > 5 × ULN.

A single non-ALS patient with epilepsy treated with concomitant carbamazepine and phenobarbital experienced marked, rapid elevations of liver enzymes with jaundice (ALT 26 × ULN, AST 17 × ULN, and bilirubin 11 × ULN) four months after starting RILUTEK; these returned to normal 7 weeks after treatment discontinuation.Maximum increases in serum ALT usually occurred within 3 months after the start of riluzole therapy and were usually transient when < 5 times ULN.

In trials, if ALT levels were < 5 times ULN, treatment continued and ALT levels usually returned to below 2 times ULN within 2 to 6 months.

Treatment in studies was discontinued, however, if ALT levels exceeded 5 × ULN, so that there is no experience with continued treatment of ALS patients once ALT values exceed 5 times ULN.

Treatment should be discontinued if ALT levels are ? 5 × ULN or if clinical jaundice develops (see PRECAUTIONS: Laboratory Tests).

There were rare instances of jaundice and hepatitis.

Serum aminotransferases including ALT levels should be measured before and during riluzole therapy.

Serum ALT levels should be evaluated every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter.

Serum ALT levels should be evaluated more frequently in patients who develop elevations.

(see PRECAUTIONS).

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