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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.
The complete, revised labeling is available at this link through Drugs@FDA.
Richard Klein
Office of Health and Constituent
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
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