Label Changes for:

Adagen (pegademase bovine) Injection

June 2014

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)

 

June 2014

ADVERSE REACTIONS

  • Hematologic events: thrombocytopenia and autoimmune thrombocytopenia
  • Lymphomas
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