Label Changes for:

Platinol (cisplatin for injection, USP)

August 2011

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

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

 

 

WARNINGS

  • Injection site reactions may occur during the administration of PLATINOL (seeADVERSE REACTIONS). Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration. A specific treatment for extravasation reactions is unknown at this time.

 

ADVERSE REACTIONS

Neurotoxicity
  • leukoencephalopathy, and reversible posterior leukoencephalopathy syndrome (RPLS) have also been reported.
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