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Label Changes for:

Pegasys (ß (peginterferon alfa-2a)

February 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2011

 

ADVERSE REACTIONS

Immune system disorders
  • Liver graft rejection and renal graft rejection
Use in Specific Populations
  • Transplant Recipients-The safety and efficacy of Pegasys and Copegus treatment have not been established in patients with liver and other transplantations. As with other alpha interferons, liver and renal graft rejections have been reported on Pegasys, alone or in combination with Copegus
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