Nitrosourea alkylating agent (specialist) Pregnancy: Contraindicated in pregnancy and breast-feeding (§4.3). Safe use in pregnancy has not been established; carmustine is embryotoxic in rats and rabbits and teratogenic in rats at doses equivalent to the human dose. Women of childbearing potential should avoid becoming pregnant; male patients should use adequate contraceptive measures during treatment and for at least 6 months. It is not known whether carmustine is excreted in breast milk — breast-feeding should not be permitted during treatment.

Carmustine

Brand names: BiCNU, Gliadel

Carmustine is a nitrosourea alkylating cytotoxic agent used in brain tumours, certain lymphomas and myeloma, available as an injection and as an implantable wafer.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 150 to 200 mg/m² as a single agent in previously untreated patients

Route: Intravenous — slow infusion over 1–2 hours after the prescribed dilution, protected from light. Must NOT be given as a rapid intravenous injection; infusion time should not be less than one hour or it causes burning and pain at the injection site.

Frequency: Every 6 weeks — given either as a single dose or divided into two daily injections such as 75 to 100 mg/m² on two successive days. A repeat course must not be given until circulating blood elements have recovered (platelets above 100,000/mm³, leucocytes above 4,000/mm³), usually six weeks.

Source: UK SPC (eMC) §4.2 for Carmustine 100 mg powder and solvent for concentrate for solution for infusion (https://www.medicines.org.uk/emc/product/101767/smpc). VERBATIM: 'The recommended dose of Carmustine as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks.' COMBINATION / DEPLETED MARROW: when used with other myelosuppressive medicinal products or in patients whose bone marrow reserve is depleted, doses should be adjusted (reduced) accordingly. CONDITIONING BEFORE STEM CELL TRANSPLANT: carmustine is given in combination with other chemotherapeutic agents in patients with malignant haematological disease before SCT at an intravenous dose of 300–600 mg/m². DOSE ADJUSTMENT BY NADIR AFTER PRIOR DOSE (percentage of prior dose to give): leucocytes >4000/mm³ and platelets >100,000/mm³ → 100%; leucocytes 3000–3999 and platelets 75,000–99,999 → 100%; leucocytes 2000–2999 and platelets 25,000–74,999 → 70%; leucocytes <2000 and platelets <25,000 → 50%. MONITORING: blood counts frequently (haematological toxicity is delayed and cumulative — nadir platelets at 4–5 weeks, nadir leucocytes at 5–6 weeks); repeat courses no more often than every 6 weeks; assess hepatic, renal and pulmonary function before and regularly during therapy (spirometry FVC, DLCO). CUMULATIVE PULMONARY TOXICITY: cumulative doses of 1200–1500 mg/m² have been associated with an increased likelihood of pulmonary fibrosis; pulmonary toxicity has been observed in up to 30% of patients. ETHANOL CONTENT: a 200 mg/m² dose in a 70 kg adult gives exposure to 123.4 mg/kg of ethanol (blood alcohol concentration rise about 20.57 mg/100 mL). ELDERLY: start cautiously at the low end of the dose range and monitor renal function; higher incidence of stomatitis with high-dose carmustine. DURATION: no general limit — stop if the tumour remains incurable or serious/intolerable side effects appear. PAEDIATRIC: carmustine is CONTRAINDICATED in children and adolescents per the UK SPC §4.3, so no paediatric dose is given; US labelling states safety and effectiveness in children have not been established and reports delayed-onset pulmonary fibrosis up to 17 years after treatment given in childhood/early adolescence (8 of 17 childhood brain tumour survivors died of pulmonary fibrosis). ADMINISTRATION DISCREPANCY TO RESOLVE: the UK SPC specifies infusion over 1–2 hours (not less than one hour), whereas the US label (openFDA/DailyMed, Navinta LLC, label date 2025-11-18) specifies slow intravenous infusion over AT LEAST TWO HOURS at a rate of not more than 1.66 mg/m²/min — clinician to decide which applies locally. The eMC §4.4 and §4.8 text was truncated at the source-fetch limit.

Dose adjustments

Renal

In patients with impaired renal function the dose of carmustine should be reduced depending on the glomerular filtration rate; a higher degree of renal impairment is a contraindication. US labelling adds: evaluate renal function before administration and periodically during treatment, monitor more frequently for toxicity if renal function is compromised, and discontinue if creatinine clearance is less than 10 mL/min.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Previous hypersensitivity to carmustine, to other nitrosoureas, or to any of the excipients
Decreased circulating platelets, leucocytes or erythrocytes, whether from previous chemotherapy or other causes
Higher degree of renal impairment
Pregnancy and lactation
Children and adolescents

Side effects

Myelosuppression (very common) — onset 7–14 days, nadir 21–35 days, recovery 42–56 days; cumulative, dose-related, delayed and often biphasic; thrombocytopenia generally more severe than leucopenia and both may be dose-limiting
Severe nausea and vomiting (very common) — begins within 2–4 hours and lasts 4–6 hours; high emetogenic potential at doses >250 mg/m²
Pulmonary toxicity (very common) — interstitial fibrosis with prolonged therapy and cumulative dose >1400 mg/m²; pneumonitis at doses >450 mg/m²; may be fatal
Ocular toxicity (very common) — transient conjunctival flushing, blurred vision, retinal haemorrhages
Neurological (very common) — ataxia, dizziness, headache; encephalopathy is common with high-dose therapy and dose-limiting
Phlebitis (very common) and hypotension due to the alcohol content of the diluent (high-dose therapy); hepatotoxicity (common, reversible, delayed up to 60 days)

Interactions

Cimetidine — greater myelosuppression (leukopenia, neutropenia) reported with concomitant oral cimetidine; consider an alternative (US label §7.1; eMC §4.5 was not included in the fetched bundle)
Phenobarbital — induces carmustine metabolism and may compromise antitumour activity; consider an alternative (US label §7.1)
Phenytoin — carmustine may reduce phenytoin serum concentrations and its efficacy; consider an alternative (US label §7.2)
Medicines containing propylene glycol or ethanol — co-administration may lead to ethanol accumulation and adverse effects, as the diluent contains ethanol (eMC §4.4)

Clinical monograph

How it works

It alkylates and cross-links DNA and also carbamoylates proteins, disrupting DNA replication and leading to cell death.

Prescribing in practice

Delayed and cumulative bone marrow suppression is a major dose-limiting toxicity and can occur weeks after administration, requiring prolonged blood count monitoring.
Pulmonary toxicity, including delayed pulmonary fibrosis, can occur and necessitates baseline and ongoing assessment of lung function.
It is hepatotoxic and nephrotoxic with cumulative exposure, so liver and renal function should be monitored.

Monitoring

Monitor full blood count for a prolonged period after each dose, together with pulmonary, liver and renal function.

Counselling the patient

Report any breathlessness or a persistent cough, which may indicate lung effects.
Seek urgent advice if you develop fever, bruising or bleeding as your blood counts can fall.
Attend all scheduled blood tests, as effects on the bone marrow may appear some weeks after treatment.

Evidence & guidelines

Carmustine's use is established in standard oncology practice and reflected in the SPC and treatment guidelines.

Reference: NICE TA121; ESMO; BSH; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Pathways