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U.S. Department of Health and Human Services


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Pegasys (peginterferon alfa-2a) September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Sections Modified

MEDICATION GUIDE (provides for new information related to the green cap needles dispensed with the product.)

Instructions for Preparing and Giving a Dose with a Pegasys Prefilled Syringe

  • How do I prepare and inject Pegasys?
    • Uncover the needle.
    • For safety reasons, before you dispose of the syringe and needle, place the free end of the green cap...

Instructions for Preparing and Giving a Dose with a Pegasys Vial

  • How do I inject Pegasys?
    • Remove the needle and syringe from their packaging and attach the needle to the end of the syringe.
    • For safety reasons, always place used syringes and needles in a puncture-resistant container immediately after use and never reuse them.