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U.S. Department of Health and Human Services


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PegIntron (Peginterferon alfa-2b)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CBER) 



May 2013

Summary View


  • ......are pregnant or plan to become pregnant. PegIntron may harm your unborn baby. You should use effective birth control during treatment with PegIntron. Talk to your healthcare provider about birth control choices for you during treatment with PegIntron. Tell your healthcare provider if you become pregnant during treatment with PegIntron.


June 2012

Summary View



  • Updated in order to make it consistent with the Boxed Warning, Warnings and Precautions, and Neuropsychiatric Events subsection (section 5.2) of the Package Insert.