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U.S. Department of Health and Human Services

Safety

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Treanda (bendamustine hydrochloride)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2010

 

Summary View

 

WARNINGS and PRECAUTIONS

Extravasation
  • There are postmarketing reports of bendamustine extravasations resulting in hospitalizations from erythema, marked swelling, and pain. Precautions should be taken to avoid extravasation, including monitoring of the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of Treanda.