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.)
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