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Label Changes for:

Treanda (bendamustine hydrochloride) for Injection, 100 mg

April 2009

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009


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

Summary of Changes to Contraindications and Warnings


  • Suicidal behavior and Ideation
  • Usage in Pregnancy


  • Information for Patients


  • Skin Reactions
    • A number of skin reactions have been reported in clinical trials and post-marketing safety reports. These events have included rash, toxic skin
      reactions and bullous exanthema. Some events occurred when Treanda was given in combination...
    • case of toxic epidermal necrolysis (TEN) occurred...Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported...