Label Changes for:

Gemcitabine Injection 38 mg/mL

September 2013

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)

 

September 2013

5 WARNINGS AND PRECAUTIONS 

5.9 Capillary Leak Syndrome
  • Capillary leak syndrome (CLS) with severe consequences has been reported in patients receiving gemcitabine as a  single agent or in combination with other chemotherapeutic agents. Discontinue gemcitabine if CLS develops during  therapy
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