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Hep C Discussion Forum -> Knowledge/Info Section -> FDA approved changes to the Olysio (simeprevir) package insert to include two new Warnings and Precautions
Post Info TOPIC: FDA approved changes to the Olysio (simeprevir) package insert to include two new Warnings and Precautions
Cinnamon Girl


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FDA approved changes to the Olysio (simeprevir) package insert to include two new Warnings and Precautions
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Thursday, April 16, 2015

FDA approved changes to the Olysio (simeprevir) package insert to include two new Warnings and Precautions;

 

  1. serious symptomatic bradycardia when co-administered with sofosbuvir and amiodarone

  2. hepatic decompensation and hepatic failure.

 

Additional changes to the Indication and Usage, Dosage and Administration, Adverse Reactions, Drug Interactions, Use in Specific Populations and Pharmacokinetic sections of the label were made based on these Warnings and Precautions and are summarized below.

 

Link to full details and updated package insert...

http://hcvadvocate.blogspot.ca/2015/04/fda-approved-changes-to-olysio.html



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
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Hep C Discussion Forum -> Knowledge/Info Section -> FDA approved changes to the Olysio (simeprevir) package insert to include two new Warnings and Precautions
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