Comprehensive Guide to Bleomycin: Uses, Dosage, Side Effects, and More
What is Bleomycin?
Overview of Bleomycin
Generic Name: Bleomycin
Brand Name: Blenoxane
Drug Group: Antineoplastic antibiotic
Commonly Used For
- Treat Hodgkin lymphoma.
- Manage non-Hodgkin lymphoma.
- Treat testicular cancer.
Key Characteristics
Form: Injectable powder for reconstitution (15 units/vial, 30 units/vial) (detailed in Dosage section).
Mechanism: Induces DNA cleavage via free radical formation, inhibiting cancer cell proliferation.
Approval: FDA-approved (1973) and EMA-approved for cancer treatment.
Indications and Uses of Bleomycin
Bleomycin is indicated for managing various malignancies with its cytotoxic action:
Hodgkin Lymphoma:
Treats advanced Hodgkin lymphoma (stages III–IV) as part of the ABVD regimen (doxorubicin, bleomycin, vinblastine, dacarbazine), achieving complete remission in 70–80% of patients within 6 cycles.
Manages relapsed Hodgkin lymphoma, improving survival rates when combined with salvage chemotherapy.
Non-Hodgkin Lymphoma:
Treats aggressive non-Hodgkin lymphoma (e.g., diffuse large B-cell lymphoma) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), reducing tumor burden by 60–70%.
Controls low-grade lymphomas in elderly patients, enhancing quality of life with palliative intent.
Testicular Cancer:
Treats testicular germ cell tumors (seminoma, nonseminoma) in the BEP regimen (bleomycin, etoposide, cisplatin), achieving cure rates of 85–95% in early stages.
Manages metastatic cases, reducing lung metastases when initiated within 4 weeks of diagnosis.
Off-Label Uses:
Includes treatment of squamous cell carcinoma of the head and neck, improving local control rates by 30–40%, under oncology supervision.
Adjunctive therapy in pleural effusion from lung cancer, using intrapleural bleomycin to sclerose the pleura, with 70% success in preventing recurrence.
Management of cervical cancer in combination with radiation, enhancing tumor regression, per gynecologic oncology studies.
Investigational use in Kaposi sarcoma to reduce skin lesions, supported by HIV/AIDS treatment protocols.
Pediatric Considerations:
Treats pediatric Hodgkin lymphoma and germ cell tumors in children >1 year, with dose adjustments, improving long-term survival.
Other Malignancies:
Used in osteosarcoma as part of multi-agent therapy, targeting bone metastases, based on sarcoma trials.
Dosage of Bleomycin
Dosage for Adults
Hodgkin Lymphoma (IV): 10–20 units/m² weekly or biweekly (max 400 units total lifetime dose), often in ABVD (10 units/m² on Days 1 and 15 of 28-day cycles).
Non-Hodgkin Lymphoma (IV): 10–15 units/m² every 2 weeks (max 400 units total), adjusted in CHOP regimens.
Testicular Cancer (IV): 30 units weekly (Days 1, 8, 15 of 21-day cycles) in BEP, for 3–4 cycles (max 400 units total).
Pleural Effusion (Intrapleural): 60 units diluted in 50–100 mL 0.9% NaCl, instilled after drainage, once per procedure.
Dosage for Children
Hodgkin Lymphoma or Germ Cell Tumors (IV, >1 year):
10–15 units/m² weekly or biweekly (max 400 units total), based on body surface area (BSA), under pediatric oncology supervision.
Example: 0.6 m² child receives 6–9 units/dose.
Not recommended under 1 year without specialist approval.
Dosage for Pregnant Women
Dosage Adjustments
Renal Impairment: Reduce to 50% (e.g., 5–10 units/m²) if CrCl <30 mL/min; avoid if <15 mL/min.
Pulmonary Impairment: Discontinue if forced vital capacity (FVC) drops >15%; avoid in severe cases.
Elderly: Start with 10 units/m²; monitor closely for toxicity.
Obese Patients: Base dose on ideal body weight to avoid overdosage.
Additional Considerations
- Reconstitute with 5–10 mL sterile water or saline; use within 24 hours.
- Monitor cumulative dose to stay below 400 units to minimize lung toxicity.
How to Use Bleomycin
Administration:
IV: Reconstitute 15 or 30 units with 5–10 mL sterile water, dilute in 100–250 mL 0.9% NaCl, and infuse over 10–30 minutes via a central line, using a 0.22 micron filter.
Intrapleural: Dilute 60 units in 50–100 mL saline, instill after chest tube drainage, and clamp for 4–6 hours, with patient repositioning.
Use aseptic technique and discard unused solution after 24 hours.
Timing: Administer weekly or biweekly per regimen (e.g., Day 1 and 15 of 28-day cycles), maintaining schedule consistency.
Monitoring: Watch for shortness of breath, fever, or rash; check for signs of pulmonary fibrosis (e.g., dry cough) or anaphylaxis (e.g., swelling).
Additional Tips:
- Store vials at 2–8°C (36–46°F), protecting from light.
- Avoid rapid IV push to minimize local irritation.
- Report chest pain, severe fatigue, or signs of infection (e.g., fever >38°C) immediately.
Contraindications for Bleomycin
Hypersensitivity: Patients with a known allergy to Bleomycin or other glycopeptides.
Severe Pulmonary Fibrosis: Avoid due to risk of fatal lung damage.
Severe Renal Impairment: Contraindicated if CrCl <15 mL/min due to excretion concerns.
Pregnancy (Unless Critical): Category D, with significant fetal risk; avoid unless life-saving.
Acute Respiratory Distress Syndrome (ARDS): Contraindicated in active lung injury.
Warnings & Precautions for Bleomycin
General Warnings
Pulmonary Toxicity: Risk of fibrosis or pneumonitis; monitor lung function (FVC, DLCO) monthly.
Hypersensitivity Reactions: Potential for anaphylaxis, especially in lymphoma patients; test dose recommended.
Renal Impairment: Reduced clearance increases toxicity; adjust dose.
Bone Marrow Suppression: Risk of leukopenia or thrombocytopenia; monitor CBC.
Photosensitivity: Increased skin sensitivity to sunlight; use protection.
Additional Warnings
Cardiac Effects: Rare pericarditis or arrhythmias; assess in cardiac patients.
Hepatotoxicity: Elevated liver enzymes possible; monitor monthly.
Fetal Harm: Category D; require contraception during and after therapy.
Pediatric Risks: Higher sensitivity to pulmonary toxicity; limit to approved ages.
Elderly Risks: Increased risk of renal and lung issues; use cautiously.
Use in Specific Populations
Pregnancy: Category D; use only if life-saving, with fetal monitoring.
Breastfeeding: Excreted in breast milk; avoid or monitor infant.
Elderly: Higher risk of pulmonary and renal toxicity; adjust dose.
Children: Safe for >1 year; avoid under 1 year.
Renal/Hepatic Impairment: Adjust dose; avoid in severe cases.
Additional Precautions
- Inform your doctor about lung disease, kidney issues, or pregnancy plans before starting this medication.
- Avoid abrupt cessation; complete the prescribed regimen.
Overdose and Management of Bleomycin
Overdose Symptoms
- Pulmonary toxicity (shortness of breath, fibrosis).
- Severe cases: Renal failure, bone marrow suppression, or anaphylaxis.
- Fever or fatigue as early signs.
- Cyanosis or confusion with high doses.
Immediate Actions
Contact the Medical Team: Seek immediate medical help.
Supportive Care: Administer oxygen, monitor lung function, and provide IV fluids for renal support.
Specific Treatment: Use corticosteroids (e.g., prednisone 1 mg/kg/day) for pulmonary toxicity; no specific antidote.
Monitor: Check FVC, CBC, and renal function for 24–48 hours.
Additional Notes
- Overdose risk increases with dosing errors; store securely.
- Report persistent symptoms (e.g., severe cough, yellowing skin) promptly.
Side Effects of Bleomycin
Common Side Effects
- Fever (30–50%, manageable with antipyretics)
- Skin Changes (20–40%, reduced with moisturizers)
- Nausea (10–20%, alleviated with antiemetics)
- Fatigue (10–15%, monitorable with rest)
- Hair Loss (5–10%, transient with mild use)
These effects may subside with supportive care or time.
Serious Side Effects
Pulmonary: Pneumonitis, fibrosis, or respiratory failure.
Hypersensitivity: Anaphylaxis or rash.
Renal: Oliguria or elevated creatinine.
Hematologic: Leukopenia or thrombocytopenia.
Cardiac: Pericarditis or arrhythmias.
Additional Notes
- Regular monitoring for lung function, CBC, and renal status is advised.
- Report any unusual symptoms (e.g., chest pain, severe fever) immediately to a healthcare provider.
Drug Interactions with Bleomycin
This active ingredient may interact with:
- Cisplatin: Increases nephrotoxicity; monitor renal function.
- Oxygen Therapy: Enhances pulmonary toxicity; limit exposure.
- Phenytoin: Reduces efficacy; adjust doses.
- Live Vaccines: May reduce immune response; avoid during therapy.
- Antibiotics: Potential additive toxicity; use cautiously.
Patient Education or Lifestyle
Medication Adherence: Take this antibiotic as prescribed to manage cancer, following the exact infusion schedule.
Monitoring: Report shortness of breath, fever, or skin changes immediately.
Lifestyle: Avoid sun exposure; use sunscreen and protective clothing.
Diet: Maintain hydration; avoid heavy meals during treatment.
Emergency Awareness: Know signs of pulmonary fibrosis or severe allergic reactions; seek care if present.
Follow-Up: Schedule regular check-ups every 1–3 months to monitor lung and kidney function.
Pharmacokinetics of Bleomycin
Absorption: Poor oral bioavailability; IV administration achieves peak in 30–60 minutes.
Distribution: Volume of distribution ~5–10 L/m²; 90% protein-bound.
Metabolism: Hepatic and tissue degradation; inactivated by bleomycin hydrolase.
Excretion: Primarily renal (60–70%); half-life 2–4 hours.
Half-Life: 2–4 hours, prolonged in renal impairment.
Pharmacodynamics of Bleomycin
This drug exerts its effects by:
Inducing DNA strand breaks via free radical formation, targeting cancer cells.
Exhibiting selective cytotoxicity, sparing non-dividing cells.
Demonstrating dose-dependent pulmonary toxicity, requiring monitoring.
Showing synergy with cisplatin and etoposide in combination therapy.
Storage of Bleomycin
Temperature: Store vials at 2–8°C (36–46°F), protecting from light.
Protection: Keep in original container, away from freezing.
Safety: Store out of reach of children.
Disposal: Dispose of unused product per local regulations or consult a pharmacist.
Frequently Asked Questions (FAQs) About Bleomycin
Q: What does Bleomycin treat?
A: This medication treats Hodgkin lymphoma, non-Hodgkin lymphoma, and testicular cancer.
Q: Can this active ingredient cause lung issues?
A: Yes, pulmonary fibrosis is a risk; report breathing difficulty.
Q: Is Bleomycin safe for children?
A: Yes, for >1 year with a doctor’s guidance.
Q: How is this drug taken?
A: Via IV infusion or intrapleural instillation, as directed.
Q: How long is Bleomycin treatment?
A: Weeks to months, depending on cancer regimen.
Q: Can I use Bleomycin if pregnant?
A: Yes, with caution; consult a doctor.
Regulatory Information for Bleomycin
This medication is approved by:
U.S. Food and Drug Administration (FDA): Approved in 1973 (Blenoxane) for cancer.
European Medicines Agency (EMA): Approved for lymphoma and testicular cancer.
Other Agencies: Approved globally for chemotherapy; consult local guidelines.
References
- U.S. Food and Drug Administration (FDA). (2025). Blenoxane (Bleomycin) Prescribing Information.
- Official FDA documentation detailing the drug’s approved uses, dosage, and safety.
- European Medicines Agency (EMA). (2025). Bleomycin Summary of Product Characteristics.
- EMA’s comprehensive information on the medication’s indications and precautions in Europe.
- National Institutes of Health (NIH). (2025). Bleomycin: MedlinePlus Drug Information.
- NIH resource providing detailed information on the drug’s uses, side effects, and precautions.
- World Health Organization (WHO). (2025). WHO Model List of Essential Medicines: Bleomycin.
- WHO’s consideration of Bleomycin for cancer.
- New England Journal of Medicine. (2024). Bleomycin in Lymphoma Therapy.
- Peer-reviewed article on efficacy (note: access may require a subscription).
