ahfs drug information 2011 pdf

If an elevation in serum alanine aminotransferase ALT or aspartate aminotransferase AST concentrations exceeding 5 times the upper limit of normal ULN occurs with an elevation in total bilirubin concentrations no more than 2 times the ULN, ceritinib therapy should be withheld until the liver function test results return to baseline values or decrease to no more than 3 times the ULN. If pregnancy occurs, advise patient of potential risk to the fetus. Because the pharmacokinetics of ceritinib have not been studied in patients with moderate to severe hepatic impairment, the recommended dosage of the drug has not yet been determined in such patients. It is a worthy addition to the personal library of physicians, pharmacists, nurse practitioners, and other prescribers. In a population pharmacokinetic analysis, the systemic exposure to ceritinib was similar in patients with mild hepatic impairment total bilirubin concentration no more than the ULN with AST concentration exceeding the ULN or total bilirubin concentration exceeding 1—1.

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