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U.S. Department of Health and Human Services


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Platinol (cisplatin for injection, USP)

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


Summary View



  • 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.



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