Label Changes for:

BiCNU (carmustine for injection)

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 BiCNU (see ADVERSE REACTIONS: Other Toxicities). Given the possibility of extravasation, close monitoring of the infusion site for possible infiltration during drug administration is recommended. A specific treatment for extravasation reactions is unknown at this time.

 

ADVERSE REACTIONS

  • Local soft tissue toxicity has been reported following extravasation of BiCNU. Infiltration of BiCNU may result in swelling, pain, erythema, burning sensation, and skin necrosis.
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