A warning about cases of pancytopenia linked to the use of the oral hepatitis C antiviral drug boceprevir has been added to the drug’s label, the Food and Drug Administration has announced.
There have been postmarketing reports of "serious cases" of pancytopenia in people treated with boceprevir in combination with peginterferon alfa and ribavirin, according to the FDA. This information has been added to the "Warnings and Precautions" section of the label, with the recommendation that "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."
Approved in 2011, boceprevir is an HCV Ns3/4A protease inhibitor approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders. Boceprevir, in a 200-mg capsule formulation, is marketed as Victrelis by Merck Sharp & Dohme; the recommended dose is 800 mg, three times a day.
The boceprevir Medication Guide will also be updated with this information, according to the FDA.
Serious adverse events associated with boceprevir should be reported to the FDA at 800-332-1088 or at MedWatch.