Classes
DEA Class; Rx
Common Brand Names; BiCNU, Gliadel
- Antineoplastics, Alkylating
Description
A nitrosourea alkylating agent
IV formulation used for brain tumors including malignant gliomas and glioblastoma multiforme, multiple myeloma, Hodgkin lymphoma, and non-Hodgkin’s lymphoma; implantable wafer used for newly diagnosed high-grade glioma as an adjunct to surgery and radiation and for recurrent glioblastoma as an adjunct to surgery
IV formulation has a black box warning for myelosuppression and pulmonary toxicity
Indications
Indicated for recurrent glioblastoma as an adjunct to surgery
Indicated for newly-diagnosed high-grade glioma as an adjunct to surgery and radiation
Contraindications
Hypersensitivity
Adverse Effects
- Convulsions (19%)
- Hemiplegia (19%)
- Headache (15%)
- Metabolic disorder (14%)
- Somnolence (14%)
- Fever (12%)
- 1-10%
- Confusion (10%)
- Aphasia (9%)
- Nausea (8%)
- Vomiting (8%)
- Pain (7%)
- Rash (5%)
- Abscess (4%)
- Cranial edema (4%)
- ICP elevation (4%)
- Meningitis (4%)
- Hyperglycemia (3%)
- HTN (3%)
- Constipation (2%)
- Diarrhea (2%)
- Dizziness (2%)
- Depression (2
Warnings
Do not give more frequently than q6-8wk due to delayed myelosuppression; complete blood count should be monitored weekly for at least six weeks after each dose
Risk of irreversible pulmonary fibrosis on long-term treatment
Injection site reactions may occur during administration; rapid infusion may cause burning along the vein and flushing of skin
Extravasation risk, monitor closely during infusion
Ocular toxicity associated with intracarotid route (investigational); safety and efficacy not established
Associated with moderate to high emetic potential; administer antiemetics to prevent nausea and vomiting
Monitor liver function tests periodically during therapy; reversible increases (rare) in bilirubin, alkaline phosphatase levels, and transaminases reported
Wafer implant associated with intracranial hypertension; brain edema reported in patients with newly diagnosed glioma; monitor closely for intracranial hypertension related to brain edema, inflammation, or necrosis of brain tissues surrounding resection; in refractory cases, removing the wafer may be necessary
Meningitis reported in patients with recurrent glioma receiving wafer implants; monitor postoperatively for signs/symptoms of meningitis and CNS infection
Renal failure, decreased kidney size, and progressive azotemia reported in patients receiving low or large cumulative doses or prolonged treatment; monitor renal function periodically
Long-term use associated with development of secondary malignancies (acute leukemia and bone marrow dysplasias)
Pregnancy and Lactation
Therapy can cause fetal harm when administered to a pregnant woman; there are no available data on use in pregnant women
No data are available regarding presence of drug or metabolites in human milk or effects on breastfed child or on milk production
Maximum Dosage
IV: 200 mg/m2 IV every 6 weeks; doses of 300 mg/m2 have been used in combination with other agents for stem-cell transplant preparation. Wafers: 61.6 mg (eight 7.7-mg wafers) implanted intracranially.
IV: 200 mg/m2 IV every 6 weeks; doses of 300 mg/m2 have been used in combination with other agents for stem-cell transplant preparation.[44331] [44330]Wafers: 61.6 mg (eight 7.7-mg wafers) implanted intracranially.
Safety and efficacy not established.
Safety and efficacy not established.
How supplied
Carmustine
powder for injection
- 100mg
wafers
- 7.7mg
