February 13, 2014

FDA Hepatitis Update - Label update for Victrelis (boceprevir)

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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.

Refer to the Package Inserts for ribavirin and peginterferon alfa for guidelines for discontinuation of therapy based on laboratory parameters.

Additionally section 6.2 Postmarketing Experience was updated to include agranulocytosis, pancytopenia, thrombocytopenia, pneumonia and sepsis.

The corresponding patient information and Medication Guide were also updated to reflect these changes.

The complete revised label can be viewed at Drugs@FDA.

Victrelis is a product of Merck Sharp & Dohme Corp.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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