Welcome, Guest. Please login or register.
April 18, 2024, 09:29:21 am

Login with username, password and session length


Members
  • Total Members: 6307
  • Latest: golfer
Stats
  • Total Posts: 55125
  • Total Topics: 4851
  • Online Today: 69
  • Online Ever: 1314
  • (June 22, 2016, 05:23:42 am)
Users Online
Users: 0
Guests: 62
Total: 62

Welcome

Welcome to the Hep Forums, a round-the-clock discussion area for people who have Fatty Liver Disease, Hepatitis B, C or a co-infection, their friends and family and others with questions about hepatitis and liver health. Check in frequently to read what others have to say, post your comments, and hopefully learn more about how you can reach your own health goals.

Privacy Warning: Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.
  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.
  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.
  • Product advertisement (including links); banners; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from the Hep Forum Moderators.
Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: FDA Hepatitis Update - OLYSIO (simeprevir) label revisions  (Read 7612 times)

0 Members and 1 Guest are viewing this topic.

Offline lporterrn

  • Member
  • Posts: 1,969
  • 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‑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.
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

  • Member
  • 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

  • Member
  • Posts: 1,969
  • 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

  • Member
  • 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

 


© 2024 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.