Simeprevir Label Adds Interactions with Transplant Rejection Drugs

The U.S. Food and Drug Administration recently approved revisions to the product label information for Janssen's new hepatitis C protease inhibitor simeprevir (Olysio), noting drug interactions with cyclosporine and tacrolimus, which are used to prevent organ rejection after a transplant.

Over years or decades, chronic hepatitis C virus infection can lead to severe liver damage that necessitates a liver transplant. Transplant recipients are among the most in need of hepatitis C treatment as well as the most difficult to treat, in part due to complications related to other drugs they must take.

Below is an edited excerpt from an FDA announcement describing the label changes.

FDA Hepatitis Update -- Olysio (simeprevir) Label Revisions

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.

9/12/14

Source

R Klein, K Struble, and S Morin, Food and Drug Administration. Olysio (simeprevir) label revisions. FDA Hepatitis Update. September 11, 2014.