BiCNU Warnings

BiCNU (carmustine for injection) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of BiCNU (see as follows and Adverse Reactions).
Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose (see Adverse Reactions). At the recommended dosage, courses of BiCNU should not be given more frequently than every 6 weeks. The bone marrow toxicity of BiCNU is cumulative; therefore, dosage adjustment must be considered on the basis of nadir blood counts from prior dose (see table in Dosage & Administration).
Pulmonary toxicity from BiCNU appears to be dose related. Patients receiving greater than 1400 mg/m² cumulative dose are at significantly higher risk than those receiving less. Additionally delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in patients who received BiCNU in childhood and early adolescence (see Adverse Reactions and Use in Children under Precautions.).
Long-term use of nitrosoureas has been reported to be associated with the development of secondary malignancies.
Liver and renal function tests should be monitored periodically (see Adverse Reactions).
BiCNU has been administered through an intraarterial intracarotid route; this procedure is investigational and has been associated with ocular toxicity.
Injection site reactions may occur during the administration of BiCNU (see Other Toxicities under Adverse Reactions). 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.
Use in Pregnancy: BiCNU (carmustine for injection) may cause fetal harm when administered to a pregnant woman. BiCNU has been shown to be embryotoxic in rats and rabbits and teratogenic in rats when given in doses equivalent to the human dose. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.