Antitumour antibiotic (specialist) Pregnancy: Should not be used during pregnancy unless strictly necessary, particularly in the first trimester; crosses the placenta with potential risk of embryonic/foetal abnormalities. Effective contraception required (male and female) up to 6 months after therapy. Breastfeeding contraindicated. May cause irreversible infertility. (US labelling: Pregnancy Category D.)

Bleomycin

Brand names: Bleomycin

Bleomycin is an injectable cytotoxic antibiotic used in oncology, notably for lymphomas, germ-cell tumours and squamous cell carcinomas.

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: Squamous cell carcinoma: 10-15 x10^3 IU/m2 body surface area, once or twice a week (IM or IV injection), at intervals of 3-4 weeks

Route: Intravenous, intramuscular, intra-arterial, subcutaneous or intrapleural instillation (occasionally direct intratumoural)

Frequency: Once or twice a week; intervals of 3-4 weeks (see per-indication schedules)

Max: Lifetime cumulative dose should not exceed 400 x10^3 IU (corresponding to 225 x10^3 IU/m2 BSA) in patients under 60 due to pulmonary toxicity risk; lymphoma patients no more than 225 x10^3 IU total

SAFETY: SPC states posology for ALL indications must be prescribed in International Units (IU), NOT mg — 1 mg dry substance = at least 1500 IU but this conversion should NOT be used as it may cause overdose. Specialist oncology use only. Doses by indication: (1) Squamous cell carcinoma — 10-15 x10^3 IU/m2 IM/IV once or twice weekly, intervals 3-4 weeks, up to lifetime cumulative 360 x10^3 IU; OR IV infusion 10-15 x10^3 IU/m2/day over 6-24 h on 4-7 consecutive days, intervals 3-4 weeks. (2) Hodgkin's disease / non-Hodgkin's lymphoma (monotherapy) — 5-15 x10^3 IU/m2 IM/IV once or twice weekly up to cumulative total 225 x10^3 IU; because of anaphylactoid reactions, treat lymphoma patients with lower doses (e.g. 2 x10^3 IU) for the first two applications and observe 4 h. (3) Testicular tumours — 10-15 x10^3 IU/m2 IM/IV once or twice weekly, intervals 3-4 weeks, up to cumulative 400 x10^3 IU; OR IV infusion 10-15 x10^3 IU/m2/day over 6-24 h on 5-6 consecutive days, intervals 3-4 weeks. (4) Malignant pleural effusions — 60 x10^3 IU in 100 mL physiological saline intrapleurally as a single dose, repeatable after 2-4 weeks (approx 45% absorbed — count toward cumulative dose). Development of stomatitis is a useful guide to individual maximum tolerance. Elderly (from age 60): reduce total dose — 80+ yrs: total 100 x10^3 IU (15 x10^3 IU/week); 70-79 yrs: total 150-200 x10^3 IU (30 x10^3 IU/week); 60-69 yrs: total 200-300 x10^3 IU (30-60 x10^3 IU/week). Paediatric population: insufficient experience; administer to children only in exceptional circumstances at special facilities; dose usually calculated on BSA within a combination regimen per current specialised protocols — verify against a children's formulary and current protocols. Dose may require adjustment (reduction) in combination therapy and with radiotherapy. NB US labelling (openFDA) expresses dose in units/kg (0.25-0.50 units/kg = 10-20 units/m2 weekly or twice weekly) — verify vs UK SPC IU units.

Dose adjustments

Renal

Elimination delayed in renal failure (especially CrCl <35 mL/min). No specific guidelines, but recommended: moderate renal impairment (GFR 10-50 mL/min) 75% of usual dose at usual intervals; severe renal failure (GFR <10 mL/min) 50% of usual dose at normal intervals; no adjustment if GFR >50 mL/min. (US labelling provides a graded % reduction table by CrCl.)

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

Hypersensitivity to the active substance or any excipient
Ataxia telangiectasia
Pulmonary infection, severely impaired lung function or history of lung damage caused by bleomycin
Breastfeeding

Side effects

Pulmonary reactions — interstitial pneumonitis / pulmonary fibrosis (approx 10%; approx 1% fatal)
Sclerosis of skin, hyperpigmentation (very common, approx 40.6%)
Fever and rigors (approx 39.8%)
Alopecia (approx 29.5%)
Anorexia and weight decrease (approx 28.7%)
Nausea and vomiting; stomatitis/mucositis; nail changes

Interactions

Nephrotoxic drugs — may reduce renal clearance of bleomycin (bleomycin is eliminated predominantly by renal excretion)
Cisplatin — decreased bleomycin clearance; cisplatin-induced renal impairment associated with fatal pulmonary toxicity (per US labelling)
Thoracic radiotherapy — increases risk of mucosal damage and pulmonary toxicity; reduce bleomycin dose
Combination chemotherapy — bleomycin dosage may require adjustment

Clinical monograph

How it works

It is a glycopeptide that binds DNA and, through metal-ion and oxygen-dependent free-radical generation, causes single- and double-strand DNA breaks.

Prescribing in practice

Cumulative dose-related pulmonary toxicity, presenting as pneumonitis that can progress to irreversible fibrosis, is the dose-limiting hazard and requires monitoring with a defined lifetime cumulative limit.
Acute reactions including fever, chills and rare anaphylactoid/hyperpyrexial responses can occur, particularly in lymphoma, so test dosing and observation are used.
Mucocutaneous effects such as skin pigmentation, hyperkeratosis and Raynaud's phenomenon are common.

Monitoring

Monitor respiratory symptoms, lung function and the cumulative lifetime dose closely throughout treatment.

Counselling the patient

Report any new cough or breathlessness immediately.
Tell any future anaesthetist you have received bleomycin, as high inspired oxygen can worsen lung injury.

Evidence & guidelines

Use is well established within standard combination chemotherapy regimens supported by clinical trials and oncology guidelines.

Reference: BSH lymphoma; ESMO; AAGBI bleomycin guidance; 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.

Calculators

Pathways