Label Changes for:

DepoCyt (cytarabine liposome injection)

August 2011

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2011

 

 

WARNINGS

  • Blockage to CSF flow may result in increased free cytarabine concentrations in the CSF and an increased risk of neurotoxicity. Therefore, as with any intrathecal cytotoxic therapy, consideration should be given to the need for assessment of CSF flow before treatment is started.
  • Following intrathecal administration of DepoCyt, central nervous system toxicity, including …. visual disturbances including blindness which may be total and permanent.
  • …In some cases, a combination of neurological signs and symptoms have been reported as Cauda Equina Syndrome
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