Severe liver injury (i.e., increased serum transaminase concentrations, jaundice, hepatic encephalopathy, acute hepatic failure) reported, sometimes resulting in hospitalization and/or rarely death; manifestations generally occurred within first 3 months and in some patients, were reversible after discontinuance.
Measure serum transaminase concentrations prior to initiation of therapy, monthly during first 4 months, and periodically thereafter.
Immediately measure serum transaminase (especially ALT) concentrations if manifestations suggestive of liver dysfunction (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, flu-like symptoms, hyperbilirubinuria, jaundice, right upper quadrant tenderness) occur.
Immediately discontinue if jaundice develops or serum ALT concentration is >2 times ULN; monitor liver function closely until resolves.
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