Label Changes for:
BiCNU (carmustine for injection)
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
- 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.
- 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.