<p><strong>Hepatic Injury</strong>: Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking Riluzole. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with Riluzole.<br />
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In clinical studies, the incidence of elevations in hepatic transaminases was greater in Riluzoletreated patients than&nbsp;placebo-treated patients. The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in Riluzole-treated patients. Maximum increases in ALT occurred within 3 months after starting Riluzole. About 50% and 8% of Riluzoletreated patients in pooled Studies 1 and 2, had at least one elevated ALT level above ULN and above 3 times ULN, respectively&nbsp;<br />
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Monitor patients for signs and symptoms of hepatic injury, every month for the first 3 months of treatment, and periodically thereafter. The use of Riluzole is not recommended if patients develop hepatic transaminases levels greater than 5 times the ULN. Discontinue Riluzole if there is evidence of liver dysfunction (e.g., elevated bilirubin).<br />
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<strong>Neutropenia</strong>: Cases of severe neutropenia (absolute neutrophil count less than 500 per mm3) within the first 2 months of Riluzole treatment have been reported. Advise patients to report febrile illnesses.<br />
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<strong>Interstitial Lung Disease</strong>: Interstitial lung disease, including hypersensitivity pneumonitis, has occurred in patients taking Riluzole. Discontinue Riluzole immediately if interstitial lung disease develops.</p>