Label Changes for:
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. |
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.
