Carmustine injection is indicated as palliative therapy, either as a single agent or in combination with other established chemotherapy drugs, for the treatment of the following conditions:

• Brain tumor, including Glioblastoma, brainstem glioma, Medulloblastoma, Astrocytoma, Ependymoma, and metastatic brain tumors
• Multiple myeloma, in combination with Prednisone
• Hodgkin lymphoma that is relapsed or refractory, in combination with other approved drugs
• Non-Hodgkin lymphoma that is relapsed or refractory, in combination with other approved chemotherapy agents

The exact mechanism of action of Carmustine is not completely understood. Carmustine acts primarily by alkylating DNA and RNA, which interferes with the replication and function of genetic material in cancer cells. Unlike some other alkylating agents, Carmustine does not show complete cross-resistance with other drugs of the same class. In addition, Carmustine may inhibit several essential enzymatic processes through carbamoylation of amino acids in cellular proteins. The metabolites formed during its breakdown in the body may also contribute to both the antitumor effects and toxicities associated with the drug.

Recommended Dosage: As a single agent, 150 to 200 mg/m² carmustine intravenously every 6 weeks as a single dose or divided into daily injections such as 75 to 100 mg/m² on 2 successive days. Adjust dose for combination therapy or in patients with reduced bone marrow reserve.

Administer reconstituted solution only as a slow intravenous infusion over at least 2 hours.

Carmustine may interact with several medications that can affect its efficacy or increase the risk of toxicity.

Effects of Other Drugs on Carmustine

• Cimetidine: Concomitant use of oral cimetidine with Carmustine has been associated with increased bone marrow suppression, such as leukopenia and neutropenia. Alternative medications should be considered instead of cimetidine.
• Phenobarbital: Phenobarbital may induce the metabolism of Carmustine, which could reduce its antitumor effectiveness. Alternative therapy should be considered.

Effects of Carmustine on Other Drugs

• Phenytoin: Co-administration with phenytoin may decrease phenytoin serum concentrations, potentially reducing its therapeutic effect. Alternative anticonvulsant therapy may be considered.

Carmustine is contraindicated in patients with a known hypersensitivity to Carmustine or any of its components.

The most commonly reported adverse reactions (occurring in more than 1% of patients) include: Nausea, Vomiting, Renal toxicity, Pneumonitis, Pulmonary toxicity, Myelosuppression.

Pregnancy: Carmustine injection may cause harm to the fetus when given during pregnancy due to its mechanism of action and findings from animal studies. Available data in pregnant women are limited and not sufficient to determine the risk of major birth defects or miscarriage. In animal studies, Carmustine showed embryo toxicity in rats and rabbits and caused birth defects in rats, including abnormalities in body wall closure, neural tube, eyes, and skeletal development, even at doses lower than the maximum human dose based on body surface area. When prescribing Carmustine to a pregnant woman, healthcare providers should carefully weigh the potential benefits to the mother against the possible risks to the fetus.

It is important to note that adverse pregnancy outcomes can occur regardless of maternal health or medication use. In the general U.S. population, the estimated risk of major birth defects is about 2–4%, and the risk of miscarriage is approximately 15–20%.

Lactation: There is no available information on whether Carmustine passes into human breast milk, its effects on a breastfed infant, or its impact on milk production. Since many drugs can be excreted in breast milk and Carmustine may cause serious adverse effects such as cancer risk and bone marrow suppression in infants, breastfeeding should be stopped during treatment with Carmustine.

Administration reactions: Extravasation may occur during infusion; the injection site should be monitored closely.

Carcinogenic potential: Carmustine may be carcinogenic in humans. Patients should be monitored regularly and advised to report any unusual symptoms.

Ocular toxicity: Eye toxicity has been reported when Carmustine was administered through unapproved intra-arterial routes.

Embryo-fetal toxicity: Carmustine may harm the fetus. Women of reproductive potential should be advised to avoid pregnancy during treatment.

Pediatric Use: The safety and effectiveness of Carmustine in children have not been clearly established. A long-term study reported cases of delayed pulmonary fibrosis occurring as late as 17 years after treatment in patients who received Carmustine during childhood or early adolescence (ages 1 to 16 years). In that study, 8 out of 17 patients (47%) who survived childhood brain tumors died due to pulmonary fibrosis, including all 5 patients who were initially treated before the age of 5.

Geriatric Use: Clinical studies of Carmustine did not include enough patients aged 65 years and older to determine whether their response differs from that of younger patients. However, other clinical experience has not shown significant differences between elderly and younger patients. In elderly patients, dose selection should be done cautiously, usually starting with the lowest effective dose, due to the higher likelihood of reduced liver, kidney, or heart function, as well as the presence of other diseases or concurrent medications. Since Carmustine and its metabolites are mainly excreted through the kidneys, patients with impaired renal function may have a higher risk of toxicity. Because older patients are more likely to have decreased kidney function, careful dose adjustment and regular monitoring of renal function are recommended.

Cytotoxic Chemotherapy

Store Carmustine and its diluent in a refrigerator at 2°C–8°C. Unopened vials should be kept refrigerated to maintain stability. Under recommended storage conditions, the product remains stable for up to 3 years.