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Label Changes for:

Pegasys (peginterferon alfa-2a)

November 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


What is the most important information I should know about Pegasys therapy? Body organ problems ...Cases of weakness, loss of coordination and numbness due to stroke have been reported in patients taking Pegasys, including patients with few or no expected risk factors for stroke. What are the possible side effects of Pegasys, and Pegasys taken with Copegus? ...Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Roche at 1-800-526-6367.