Black Box Warning

Severe Pulmonary Toxicity: Carmustine can cause severe, potentially fatal, pulmonary fibrosis, especially in patients who have received prior treatment with lung-toxic medications, including busulfan or bleomycin, have been irradiated to the thorax, or who have pre-existing underlying lung disease.  Pulmonary function tests should be performed prior to and periodically during carmustine therapy.  Patients should be monitored for signs and symptoms of pulmonary fibrosis and if these occur, carmustine treatment should be discontinued.  Myelosuppression: Carmustine causes severe, cumulative, and delayed myelosuppression, with leukopenia and thrombocytopenia, occurring 4 to 6 weeks after treatment.  Platelet nadirs typically occur by weeks 4-6 and may last 1-2 weeks.  Leukocyte and platelet counts should be monitored frequently during and after carmustine therapy.