Nebenwirkungen · Rilutek
RILUTEK 50 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 5
HOS-085919 · Präparat HOS-083218
Description of selected adverse reactions Hepato-biliary disorders Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued. These increases could be associated with jaundice. In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section 4.4). Study data indicate that Asian patients may be more susceptible to liver function test abnormalities - 3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients.
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