Indication

TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

Important Safety Information

  • Allergic Reactions: Patients with a known allergic response to bendamustine should not take TREANDA.
  • Serious Side Effects: TREANDA may cause serious side effects, including low blood cell counts, infections, unexpected responses to TREANDA when placed in your blood, sudden and severe allergic responses, kidney failure due to fast breakdown of cancer cells, other cancers, and leaking of TREANDA out of your vein and into your surrounding skin. Some of these side effects, such as low blood counts, infections, and severe allergic skin responses (when TREANDA was given with allopurinol and other medications known to cause severe allergic skin responses), have caused death. Tell your doctor right away if you have any of these side effects.
  • Changes in Therapy: Some serious side effects may require changes in therapy, such as lowering the amount of TREANDA given, stopping the use of TREANDA, or waiting longer than expected between doses of TREANDA.
  • Pregnancy: Women should avoid becoming pregnant while using TREANDA because it may cause fetal harm if you take TREANDA while pregnant.
  • Most Common Side Effects: The most common non-blood-related side effects associated with TREANDA (occurring in ≥15% of patients) are fever, nausea, and vomiting. The most common blood-related side effects associated with TREANDA (frequency ≥15%) are low red blood cells (oxygen-carrying cells), low platelets (blood-clotting cells), and decreased number of three different types of white blood cells (infection-fighting cells).
©2013 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. TRE-40274 November 2013.
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