Journal
JOURNAL OF CLINICAL PHARMACOLOGY
Volume 46, Issue 2, Pages 149-156Publisher
SAGE PUBLICATIONS INC
DOI: 10.1177/0091270005283464
Keywords
fingolimod; immunosuppression; hepatic impairment; dose adjustment
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The authors assessed the impact of severe hepatic impairment on the disposition of fingolimod-a sphinosine-1-phosphate receptor immunomodulator primarily metabolized by CYP4F2-in 6 patients and 6 matched healthy controls who received a single 5-mg oral dose. Compared with healthy controls, severe hepatic-impaired Subjects had a doubled area under the concentration time curve (AUC) and 50% prolonged elimination half-life but a similar peak blood concentration. When these data were combined with those from a previous study in mild and moderate hepatic-impaired subjects, there were significant positive correlations between fingolimod AUC versus bilirubin (r = 0.683) and prothrombin time (r = 0,777) and a significant negative correlation versus albumin (r = 0.578). confirming the importance of liver function for fingolimod clearance. For patients with severe hepatic impairment (Child-Pugh class C) a standard first dose of fingolimod could be given followed by a maintenance dose that is reduced by half from the normal maintenance dose.
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