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Author Topic: FDA Hepatitis Update - OLYSIO (simeprevir) label revisions  (Read 6174 times)

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Offline lporterrn

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  • LucindaPorterRN
    • LucindaPorterRN
FDA Hepatitis Update - OLYSIO (simeprevir) label revisions
« on: September 11, 2014, 05:04:13 pm »
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‚ÄĎadministered 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.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline willie g

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  • Posts: 427
  • geno 1 25million etc. s/o for treatment
Re: FDA Hepatitis Update - OLYSIO (simeprevir) label revisions
« Reply #1 on: September 11, 2014, 05:23:43 pm »
SO Lucinda in regards to a good old country boy from NY,, can you break that down or is it already brokedown? bottom line are these new side effects and do I have to worry n regards to my staus[ whatever my staus is,lol we don't,, and never will have time for all that, ha ha and just for shits and GIGGLES thankyou for the Snoopy Dance!,,, isn't charlie brown great!]   have nice day and HOW ARE YOU  doing fellow hep Patron? you always hear our posts so humbly, can you give us an update on Lucinda, because WE do care.    just,,wilie g

Offline lporterrn

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  • LucindaPorterRN
    • LucindaPorterRN
Re: FDA Hepatitis Update - OLYSIO (simeprevir) label revisions
« Reply #2 on: September 11, 2014, 10:34:43 pm »
Basically, it means that if you are taking these drugs (Cyclosporine or Tacrolimus) along with Olysio, you need to be monitored or don't take Olysio.

Love the new Favicon Wllie!

Thank you for asking - I am good. Today I played hooky for an hour and went go-cart racing with a bunch of other 60+ y/o women. Life doesn't get much better than that!
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline willie g

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  • Posts: 427
  • geno 1 25million etc. s/o for treatment
Re: FDA Hepatitis Update - OLYSIO (simeprevir) label revisions
« Reply #3 on: September 12, 2014, 09:37:37 am »
now that i understand Lucinda and good for you! i am in that 60 club also and i cant remember the last time i had a good old go-cart ride.  size hinders me a little from my younger days lol but hey thanks to this hep thing the size part may now be possible,  only thing is it hasn't done anything to my height yet.have a great weekend and enjoy the laughs!  ''just'' Willie g

 


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