RILUTEK

Generic Name/API: riluzole

Manufacturer: Sanofi

Dosage Forms & Strength & Pack Size:
Tablets: 50 mg, 56’s

Storage:
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), and protect from
bright light.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
RILUTEK is indicated for the treatment of patients with Amyotropic Lateral Sclerosis (ALS).
Riluzole extends survival and/or time to tracheostomy.

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 transferace (GGT) levels (see PRECAUTIONS AND DOSAGE 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 X ULN, and about 2% of patients will have elevation > 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 X ULN, AST 17 X ULN, and bilirubin 11 x 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 ATL levels usually returned to below 2 times ULN within 2 to 6 months. Treatment in studies was discontinued, however, if ALT levels exceeded 5 X ULN, so that there is no experience with continued treatment of ALS patients once ALT values exceed 5 times ULN (see PRECAUTIONS: Laboratory Tests). There were instances of jaundice. Liver chemistries should be monitored (see PRECAUTIONS). Neutropenia Among approximately 400 patients given riluzole for ALS, there were three cases of marked neutropenia (absolute neutrophil count less than 500/mm³), all seen within the first 2 months of riluzole treatment. In one case, neutrophil counts rose on continued treatment. In a second case, counts rose after therapy was stopped. A third case was more complex, with marked anemia as well as neutropenia and the etiology of both is uncertain. Patients should be warned to report any febrile illness to their physicians. The report of febrile illness should prompt treating physicians to check white blood cell counts. Interstitial lung disease Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe. If respiratory symptoms develop such as dry cough and/or dyspnea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after drug discontinuation and symptomatic treatment. PRECAUTIONS Use in patients with Concomitant Disease RILUTEK should be used with caution in patients with concomitant liver and/or renal insufficiency (see WARNINGS, CLINICAL PHARMCOLOGY). In particular, in cases of RILUTEK-induced hepatic injury manifested by elevated liver enzymes, the effect of the hepatic injury on RILUTEK metabolism is unknown. Special Populations Riluzole should be used with caution in elderly patients whose hepatic or renal functions maybe compromised due to age. Also, females may posses a lower metabolic capacity to eliminate riluzole compared to males respectively (see CLINICAL PHARMACOLOGY: Special Populations).

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