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Hep C Discussion Forum -> On Treatment -> OLYSIO: FDA Update Label Revisions
Post Info TOPIC: OLYSIO: FDA Update Label Revisions
skewedButNotBroken


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RE: OLYSIO: FDA Update Label Revisions
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Man, you are good. That is probably what is going on with Finbar.



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Diag. with hep c in 1992; A3:F2;  GT 1a; IL28B CT; VL 900k, ALT 150, AST 100 on 8/5/2014; SOT 9/5/2014  S/O ---VL 127 after 6 days; VL detected on day 18 but < 15.; --> UND @ EOT+ 1 year SVR!
Isiscat2011


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New info regarding Olysio drug interactions with immunosuppressants:  

 

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.



-- Edited by Isiscat2011 on Thursday 11th of September 2014 09:45:41 PM

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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
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