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OLYSIO (simeprevir) label revisions - (pdf of new simeprevir label included)
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On September 5, 2014, FDA approved revisions to the OLYSIO (simeprevir) label to update section 7: Drug Interactions and section 12: Clinical Pharmacology with new data and recommendations regarding coadministration of simeprevir and the immunosuppressants cyclosporing and tacrolimus.
Specifically the following was added to section 7:
Cyclosporine:Concomitant use of OLYSIO with cyclosporine resulted in significantly increased plasma concentrations of simeprevir due to inhibition of OATP1B1, P-gp and CYP3A by cyclosporine. It is not recommended to co-administer OLYSIO with cyclosporine.
Tacrolimus: Concomitant use of OLYSIO with tacrolimus resulted in increased plasma concentrations of simeprevir due to inhibition of OATP1B1. No dose adjustment is required for either drug when OLYSIO is co-administered with tacrolimus. Routine monitoring of blood concentrations of tacrolimus is acceptable.
Section 12 was updated to provide the results of the drug-drug interaction trials with cylcosporine and tacrolimus.
Olysio, a hepatitis C virus (HCV) NS3/4 protease inhibitor indicated for the treatment of chronic hepatitis (CHC) infection as a component of a combination antiviral treatment regimen, is a product of Janssen Products.
NEW LABEL - The complete, revised labeling is available at this link through Drugs@FDA.......http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205123s003lbl.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery


Richard Klein
- Office of Health and Constituent
Food and Drug Administration
Kimberly Struble
- Division of Antiviral Drug Products
Food and Drug
Steve Morin
- Office of Health and Constituent Affairs

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