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Hep C Discussion Forum -> Hep C News -> FDA Label update for Victrelis (boceprevir)
Post Info TOPIC: FDA Label update for Victrelis (boceprevir)
Cinnamon Girl


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Posts: 5629
Date:
FDA Label update for Victrelis (boceprevir)
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Wednesday, February 12, 2014 - The Victrelis (boceprevir) label has been updated to include the following information under Section 5 Warnings and Precautions:

5.4 Pancytopenia (Use with Ribavirin and Peginterferon Alfa)

Serious cases of pancytopenia have been reported postmarketing in patients receiving VICTRELIS in combination with peginterferon alfa and ribavirin. Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate.

(N.B. - `Pancytopenia` is a medical condition in which there is a reduction in the number of red and white blood cells, as well as in the number of platelets.)

Link to article and complete revised label...

http://hcvadvocate.blogspot.ca/2014/02/fda-hepatitis-update-label-update-for.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 -> Hep C News -> FDA Label update for Victrelis (boceprevir)
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