Bleomycin


Generic Medicine Info
Indications and Dosage
Intramuscular, Intravenous
Testicular carcinoma
Adult: 10,000-15,000 international units/m2 via IV inj over 5-10 minutes or IM inj once or twice a week, at intervals of 3-4 weeks up to a total cumulative dose of 400,000 international units. Alternatively, give 10,000-15,000 international units/m2 daily via IV infusion for 6-24 hours on 5-6 consecutive days at intervals of 3-4 weeks. Dosing and route of administration recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Dose reduction may be required.

Intramuscular, Intravenous
Squamous cell carcinoma
Adult: 10,000-15,000 international units/m2 given via IV inj over 5-10 minutes or IM inj once or twice a week, at intervals of 3-4 weeks up to a lifetime cumulative dose of 360,000 international units. Alternatively, give 10,000-15,000 international units/m2/day via IV infusion for 6-24 hours on 4-7 consecutive days, at intervals of 3-4 weeks. Dosing and route of administration recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Dose reduction may be required.

Intramuscular, Intravenous
Hodgkin's lymphoma, Non-Hodgkin's lymphoma
Adult: 5,000-15,000 international units/m2 via IV inj over 5-10 minutes or IM inj once or twice a week, up to a cumulative total dose of 225,000 international units. Dosing and route of administration recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Dose reduction may be required.

Intrapleural
Malignant pleural effusions
Adult: 60,000 international units in 100 mL NaCl 0.9% solution via the puncture cannula or drainage catheter (after drainage of pleural activity) as a single dose; may repeat after 2-4 weeks if needed. Patient position should be changed every 5 minutes for a period of 20 minutes. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Dose reduction may be required.
What are the brands available for Bleomycin in Hong Kong?
Other Known Brands
  • Bleomycin Sulfate-DBL
Renal Impairment
CrCl (mL/min) Dosage
<10
Give 50% of the usual dose at normal dosing interval.
10-50
Give 75% of the usual dose at usual dosing interval.
Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Reconstitution
IM inj: Reconstitute the contents of the vial with 1-5 mL of NaCl 0.9% solution. IV inj: Reconstitute the contents of the vial with 5-10 mL of NaCl 0.9% solution. IV infusion: Dilute contents of the vial in 200-1,000 mL of NaCl 0.9%.
Incompatibility
Incompatible with essential amino acids, riboflavin, ascorbic acid, dexamethasone, aminophylline, benzylpenicillin, carbenicillin, cefalotine, cefazoline, diazepam, furosemide, glutathione, hydrogen peroxide, hydrocortisone, methotrexate, mitomycin, nafcillin, terbutaline, thiols.
Contraindications
Ataxia telangiectasia, pulmonary infection, severely impaired lung function, history of lung damage due to bleomycin therapy. Lactation.
Special Precautions
Patient with lung cancer, previous cytotoxic drug therapy or radiation therapy (particularly chest irradiation). Smokers. Avoid vaccination with live vaccines. Moderate to severe renal impairment. Elderly. Pregnancy.
Adverse Reactions
Significant: Acute myeloid leukaemia, myelodysplastic syndrome; idiosyncratic reactions (e.g. hypotension, confusion, fever, chills, wheezing, stridor); vascular toxicity (e.g. MI, cerebrovascular insults, haemolytic uraemic syndrome, cerebral arteritis); tumour lysis syndrome, hepatotoxicity; vascular pain (IV).
Gastrointestinal disorders: Nausea, vomiting, mucositis, stomatitis.
General disorders and administration site conditions: Malaise.
Immune system disorders: Anaphylaxis, hypersensitivity.
Investigations: Weight loss.
Metabolism and nutrition disorders: Decreased appetite.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, acute respiratory distress syndrome (ARDS), lung failure, pulmonary embolism.
Skin and subcutaneous tissue disorders: Erythema, pruiritus, striae, blistering, hyperpigmentation, tenderness and swelling of fingertips, hyperkeratosis, hair loss, exanthema, urticaria, skin reddening, induration, oedema, flagellate dermatitis.
Potentially Fatal: Interstitial pneumonitis occasionally progressing into pulmonary fibrosis.
IM/Intra-arterial/Intrapleural/IV/Parenteral/SC: D
Patient Counseling Information
Women of childbearing potential and men with partners who could become pregnant must use proven birth control methods during therapy and for at least 6 months after stopping the treatment.
Monitoring Parameters
Perform pulmonary function test (e.g. total lung volume, forced vital capacity, diffusion capacity for carbon monoxide, vital capacity, total lung capacity, pulmonary capillary blood volume) to assess for pulmonary changes. Monitor chest x-ray, renal function, LFTs, temperature, body weight. Assess for signs and symptoms of hypersensitivity.
Overdosage
Symptoms: Hypotension, fever, tachycardia, generalised shock. Management: Symptomatic and supportive treatment. Administer corticosteroid and a broad-spectrum antibiotic in case of respiratory complications.
Drug Interactions
Increased risk of pulmonary toxicity with other agents with pulmonary toxicity (e.g. cisplatin, mitomycin, cyclophosphamide, methotrexate, gemcitabine), increased oxygen supply during surgical procedures, granulocyte colony-stimulating factor (GCSF). Concomitant use with vinca alkaloids may cause Raynaud-like phenomenon (including acral ischaemia) which results in necrosis of peripheral parts of the body. Significantly increased frequency and severity of pulmonary toxicity with previous or concurrent thoracic radiotherapy. Increased risk of pharyngolaryngeal mucosa inflammation (resulting in hoarseness) with previous or concurrent head or neck radiotherapy. May decrease effect of digoxin. May decrease plasma levels of phenytoin. Increased risk of agranulocytosis with clozapine. May decrease the bacteriostatic efficacy of gentamicin, amikacin, ticarcillin. Increased risk of excessive immunosuppression and risk of lymphoproliferation with ciclosporin and tacrolimus.
Potentially Fatal: May result in serious infections with live vaccines.
Action
Description:
Mechanism of Action: Bleomycin is an antineoplastic agent which binds to single and double stranded DNA, resulting in single and double strand breaks. This causes suppression of cell division and growth, and subsequent inhibition of DNA synthesis. Additionally, it also inhibits the synthesis of RNA and protein to a lesser extent.
Pharmacokinetics:
Absorption: Bioavailability: 100% (IM); 70% (SC); 45% (intrapleural). Time to peak plasma concentration: 30-60 minutes (IM, SC, intrapleural).
Distribution: Rapidly distributed to the tissues with highest concentrations in the skin, lungs, peritoneum and lymph nodes; low concentrations in bone marrow. Crosses the placenta. Volume of distribution: 17.5 L/m2. Plasma protein binding: 1%.
Metabolism: Enzymatic inactivation by bleomycin hydrolase (cytosolic cysteine proteinase enzyme).
Excretion: Via urine (approx 65% [IV]; 40%[intrapleural]). Terminal elimination half-life: 2 hours (IV).
Chemical Structure

Chemical Structure Image
Bleomycin

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5360373, Bleomycin. https://pubchem.ncbi.nlm.nih.gov/compound/Bleomycin. Accessed Nov. 25, 2024.

Storage
Store between 2-8°C. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DC01 - bleomycin ; Belongs to the class of other cytotoxic antibiotics. Used in the treatment of cancer.
References
Anon. Bleomycin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/06/2024.

Bleomycin 15,000 International Units for Solution for Injection/Infusion (Neon Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/06/2024.

Bleomycin Injection, Powder, Lyophilized, for Solution (Hikma Pharmaceuticals USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/06/2024.

Bleomycin. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/06/2024.

Brayfield A, Cadart C (eds). Bleomycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2024.

DBL Bleomycin Sulfate for Injection (Zydus Hospira Oncology Private Limited [Zhopl]). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/06/2024.

Joint Formulary Committee. Bleomycin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2024.

Pfizer New Zealand Limited. DBL Bleomycin Sulfate data sheet 12 October 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 06/06/2024.

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