Bleomycin Accord
Bleomycin (as bleomycin sulfate) – Cytotoxic antibiotic for cancer treatment
Quick Facts about Bleomycin Accord
Key Takeaways
- Pulmonary toxicity is the greatest risk: The most serious side effect is lung damage (interstitial pneumonitis and pulmonary fibrosis). Regular lung function tests are required throughout treatment.
- A test dose is mandatory for lymphoma patients: Due to the risk of severe anaphylactic-like reactions, a test dose must be given and the patient observed for at least 4 hours before starting full treatment.
- Cumulative dose limits must be respected: The lifetime dose should not exceed 400,000 IU for patients under 60, with lower limits for older patients, to reduce the risk of irreversible lung damage.
- Supplemental oxygen increases lung toxicity risk: Patients must inform all healthcare providers (especially anesthesiologists) that they have received bleomycin, as high oxygen concentrations during surgery can cause severe pulmonary injury.
- Not recommended during pregnancy: Bleomycin can harm the fetus. Effective contraception is required during treatment and for 6 months after the last dose.
What Is Bleomycin Accord and What Is It Used For?
Bleomycin Accord is a cytotoxic chemotherapy medicine that belongs to a group of drugs called antineoplastic antibiotics. It works by damaging DNA in cancer cells, preventing them from dividing and growing. Bleomycin is used to treat several types of cancer, either alone or in combination with other anticancer drugs and/or radiation therapy.
Bleomycin is a glycopeptide antibiotic originally isolated from the bacterium Streptomyces verticillus. Unlike traditional antibiotics used to treat bacterial infections, bleomycin is classified as a cytotoxic antibiotic because its primary therapeutic use is in the treatment of cancer. The drug exerts its anticancer effects by generating free radicals that cause single- and double-strand breaks in DNA, ultimately preventing cancer cells from replicating and leading to cell death.
Bleomycin is particularly effective against rapidly dividing cells and shows the greatest activity during the G2 and M phases of the cell cycle. One of its unique pharmacological characteristics is that it causes relatively little bone marrow suppression compared to many other chemotherapy agents, making it a valuable component in multi-drug regimens where myelosuppression from other agents may be dose-limiting.
Bleomycin Accord is approved and used for the treatment of the following conditions:
- Squamous cell carcinoma of the head and neck, cervix, and external genitalia
- Hodgkin lymphoma – one of the most common indications, often used as part of the ABVD regimen (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
- Non-Hodgkin lymphoma – intermediate and high-grade subtypes
- Testicular cancer – typically used as part of the BEP regimen (Bleomycin, Etoposide, Cisplatin)
- Malignant pleural effusions – administered intrapleurally to control fluid accumulation in the lungs caused by cancer
Bleomycin is included on the WHO Model List of Essential Medicines, reflecting its importance in the global treatment of cancer. It has been a cornerstone of curative chemotherapy regimens, particularly for Hodgkin lymphoma and testicular germ cell tumors, where it has contributed significantly to the high cure rates observed in modern oncology practice.
What Should You Know Before Taking Bleomycin Accord?
Bleomycin must not be used in patients with acute lung infections, severely impaired lung function, or a history of bleomycin-induced lung damage. Special caution is needed for patients over 60, those with kidney or liver impairment, and anyone receiving or who has received chest radiation. A test dose is required for lymphoma patients.
Contraindications
Bleomycin Accord must not be used if you:
- Are allergic to bleomycin or any similar cytotoxic antibiotic
- Have ataxia telangiectasia (Louis-Bar syndrome) – a rare hereditary disorder that affects movement coordination and increases infection risk. Patients with this condition are extremely sensitive to bleomycin and can develop fatal reactions.
- Have an acute lung infection or severely impaired lung function
- Have previously suffered lung damage caused by bleomycin
- Are breastfeeding
Warnings and Precautions
Tell your doctor before receiving Bleomycin Accord if any of the following apply to you:
- You are over 60 years of age – elderly patients are at significantly higher risk of pulmonary toxicity, and total cumulative doses must be reduced
- You have kidney or liver impairment – reduced kidney function slows the elimination of bleomycin from the body, increasing the risk of toxicity
- You have or have had lung disease – pre-existing pulmonary conditions increase the risk of bleomycin-induced lung damage
- You have received or are receiving radiation therapy to the chest – radiation and bleomycin together substantially increase the risk of pulmonary fibrosis
- You have chickenpox – bleomycin may worsen the infection
- You are receiving supplemental oxygen – you must inform your doctor that you are being treated with bleomycin, as the combination with high-concentration oxygen significantly increases the risk of lung damage
- You have surgery planned – the treatment schedule may need to be adjusted, and the anesthesiologist must be informed about bleomycin treatment due to oxygen-related risks
Your doctor will monitor your lung function regularly using pulmonary function tests and chest X-rays or CT scans. Cases of acute myeloid leukemia and myelodysplastic syndrome have been reported in patients treated with bleomycin in combination with other cytotoxic agents. Additionally, tumor lysis syndrome – a metabolic emergency caused by the rapid breakdown of cancer cells – may occur in patients with rapidly growing tumors and can be prevented or managed with supportive care.
Pregnancy, Breastfeeding, and Fertility
Bleomycin poses significant risks to reproductive health and fetal development:
- Pregnancy: Animal studies have demonstrated that bleomycin can harm the developing fetus. It must not be used during pregnancy, particularly during the first trimester. If bleomycin treatment is medically necessary during the first trimester, a thorough discussion with your doctor about the risks is essential. If pregnancy occurs during treatment, genetic counseling is recommended.
- Contraception: Both men and women must use effective contraception during treatment and for at least 6 months after the last dose of bleomycin.
- Breastfeeding: It is not known whether bleomycin passes into breast milk. Due to the potential risk to the infant, breastfeeding is not permitted during bleomycin treatment.
- Fertility: Bleomycin treatment may cause permanent infertility. Men who wish to father children in the future should consider sperm banking before treatment begins.
How Does Bleomycin Interact with Other Drugs?
Bleomycin interacts with numerous medications, most critically with drugs that increase the risk of pulmonary toxicity (such as cisplatin, carmustine, and gemcitabine), drugs that affect blood circulation in combination with vinca alkaloids, and supplemental oxygen during general anesthesia. Live vaccines must not be given during bleomycin treatment.
Drug interactions with bleomycin can be clinically significant and potentially life-threatening. The most important interactions involve agents that increase the risk of pulmonary damage, as bleomycin’s dose-limiting toxicity affects the lungs. Your healthcare team will carefully review all medications you are taking before initiating bleomycin therapy.
Major Interactions
| Interacting Drug | Category | Clinical Effect |
|---|---|---|
| Cisplatin | Antineoplastic | Cisplatin causes renal impairment, which delays bleomycin elimination and increases pulmonary toxicity risk. Renal function must be monitored closely. |
| Carmustine, Mitomycin, Cyclophosphamide, Gemcitabine | Antineoplastic | Increased risk of severe pulmonary toxicity when used in combination with bleomycin. These agents have independent pulmonary toxicity profiles. |
| Vincristine, Vinblastine (vinca alkaloids) | Antineoplastic | Can cause impaired blood circulation in the extremities (Raynaud’s phenomenon). In severe cases, tissue necrosis of fingers and toes may occur. |
| Supplemental oxygen (general anesthesia) | Anesthetic gas | High inspired oxygen concentrations during surgery dramatically increase the risk of acute respiratory distress syndrome (ARDS) and fatal pulmonary injury. |
| Live vaccines | Immunization | Risk of severe or fatal generalized vaccine-related infection due to immunosuppression. Live vaccines must NOT be administered during bleomycin treatment. |
| Radiation therapy | Radiotherapy | Increases risk of pulmonary toxicity and mucosal damage. Bleomycin dose reduction may be required when combined with chest irradiation. |
Other Interactions
| Interacting Drug | Effect |
|---|---|
| Methotrexate | Increased risk of pulmonary toxicity when used together. |
| Digoxin (acetyldigoxin) | Bleomycin may reduce the effectiveness of digoxin. Serum levels should be monitored. |
| Phenytoin | Bleomycin may reduce the effectiveness of phenytoin. Serum levels should be monitored and dose adjusted. |
| Clozapine | May lead to a more severe reduction in white blood cells (agranulocytosis), increasing infection risk. |
| Ciclosporin, Tacrolimus | Risk of excessive lymphocyte proliferation due to combined immunological effects. |
| G-CSF (filgrastim, pegfilgrastim) | Pulmonary damage may be exacerbated by granulocyte colony-stimulating factor. |
| Gentamicin, Amikacin, Ticarcillin | The efficacy of these antibiotics may be reduced when used concurrently with bleomycin. |
What Is the Correct Dosage of Bleomycin Accord?
Bleomycin dosage is highly individualized and depends on the type of cancer being treated, the patient’s age, body surface area, kidney function, and whether bleomycin is used alone or in combination with other treatments. It is always administered in a hospital setting by healthcare professionals experienced in cancer chemotherapy.
Bleomycin Accord is available as a powder that must be dissolved before administration. It can be given via several routes including intravenous (IV) injection or infusion, intramuscular (IM) injection, subcutaneous (SC) injection, intra-arterial injection or infusion, intratumoral injection, or intrapleural instillation. The choice of route and dosage depends on the specific indication and clinical protocol.
Adults
Squamous Cell Carcinoma
IM or IV injection: 10,000–15,000 IU/m² body surface area, once or twice weekly, with 3–4 week intervals. IV infusion: 10,000–15,000 IU/m²/day over 6–24 hours for 4–7 consecutive days, with 3–4 week intervals. Maximum cumulative lifetime dose: 360,000 IU.
Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Monotherapy: IM or IV injection of 5,000–15,000 IU/m² once or twice weekly. Maximum cumulative dose: 225,000 IU. Due to the risk of anaphylactic reactions, lymphoma patients must receive a reduced test dose (e.g., 2,000 IU) for the first two administrations and be observed for 4 hours. If no acute reaction occurs, the normal dosing schedule may proceed.
Testicular Cancer
IM or IV injection: 10,000–15,000 IU/m² once or twice weekly, with 3–4 week intervals. IV infusion: same dose over 6–24 hours for 5–6 consecutive days. Maximum cumulative lifetime dose: 400,000 IU.
Malignant Pleural Effusions
60,000 IU in 100 mL normal saline administered intrapleurally as a single dose. May be repeated after 2–4 weeks depending on response. Approximately 45% of the intrapleural dose is absorbed systemically – this must be factored into cumulative lifetime dose calculations.
Elderly Patients (60 Years and Over)
Elderly patients are at significantly increased risk of pulmonary toxicity. The maximum cumulative dose must be reduced according to age:
| Age Group | Maximum Total Dose | Maximum Weekly Dose |
|---|---|---|
| Under 60 years | 400,000 IU | 30,000–60,000 IU |
| 60–69 years | 200,000–300,000 IU | 30,000–60,000 IU |
| 70–79 years | 150,000–200,000 IU | 30,000 IU |
| 80 years and over | 100,000 IU | 15,000 IU |
Children and Adolescents
There is insufficient clinical experience with bleomycin in pediatric patients. Until more data become available, bleomycin should only be given to children and adolescents under special circumstances at specialized oncology centers. When used as part of combination therapy, the dose is typically calculated based on body surface area and adjusted according to individual patient needs and current treatment protocols.
Patients with Kidney Impairment
Bleomycin elimination is delayed when kidney function is reduced. Dose adjustments are recommended as follows:
- GFR above 50 mL/min: No dose adjustment required
- GFR 10–50 mL/min (moderate impairment): Give 75% of the normal dose at the usual interval
- GFR below 10 mL/min (severe impairment): Give 50% of the normal dose at the usual interval
Missed Dose
If you miss a scheduled bleomycin injection, contact your treating doctor as soon as possible to determine whether and how the missed dose should be administered. Do not attempt to make up for a missed dose on your own.
Overdose
Symptoms of bleomycin overdose include low blood pressure (hypotension), fever, rapid heart rate (tachycardia), and signs of shock. There is no specific antidote for bleomycin overdose, and the drug cannot be effectively removed by dialysis. Treatment is entirely supportive and symptomatic. Pulmonary complications from overdose (fibrosis) are generally not reversible unless detected at a very early stage. If respiratory complications occur, treatment with corticosteroids and broad-spectrum antibiotics may be initiated.
What Are the Side Effects of Bleomycin Accord?
Bleomycin can cause a wide range of side effects. The most common are skin and mucous membrane reactions (affecting up to 50% of patients) and pulmonary toxicity. Fever on the day of injection is the earliest expected reaction. Skin changes including rash, pigmentation changes, and nail deformities are characteristic of bleomycin treatment.
Like all chemotherapy medications, bleomycin can cause side effects, though not all patients will experience them. Bleomycin has an unusual side effect profile compared to most other cytotoxic agents – it causes relatively little bone marrow suppression but has a high incidence of skin toxicity and carries the risk of potentially fatal pulmonary fibrosis. The development of stomatitis (mouth inflammation) is considered the most useful clinical marker for assessing individual tolerance and determining maximum dosing.
Very Common
- Interstitial pneumonitis (lung inflammation)
- Pulmonary fibrosis (scarring of lung tissue)
- Shortness of breath (dyspnea)
- Decreased appetite and weight loss
- Nausea and vomiting
- Mucositis and stomatitis (mouth and mucous membrane inflammation)
- Inflammatory skin redness (erythema)
- Itching (pruritus)
- Skin striae (stretch marks)
- Blistering of the skin
- Hyperpigmentation (darkening of the skin)
- Tenderness and swelling of fingertips
- Hyperkeratosis (thickening of the skin)
- Hair loss (alopecia)
Common
- Severe hypersensitivity/anaphylactic reactions (may be immediate or delayed)
- Idiosyncratic reactions
- Headache
- Acute respiratory distress syndrome (ARDS)
- Respiratory failure
- Pulmonary embolism (blood clot in the lungs)
- Rash, urticaria (hives), skin redness
- Skin induration (hardening)
- Edema (swelling from fluid retention)
- Fever (pyrexia), chills, and malaise
Uncommon
- Myelosuppression (bone marrow damage)
- Leukopenia, neutropenia (low white blood cells)
- Thrombocytopenia (low platelet count)
- Hemorrhage (bleeding)
- Dizziness, confusion
- Hypotension (low blood pressure)
- Angular cheilitis (mouth corner infections) and diarrhea
- Nail deformities and discoloration
- Muscle and joint pain
- Urinary changes (oliguria, polyuria, painful urination, urinary retention)
- Pain at tumor site
- Phlebitis (vein inflammation) and vein wall changes at injection site
Rare
- Febrile neutropenia
- Myocardial infarction (heart attack)
- Pericarditis (inflammation of the heart sac)
- Chest pain
- Cerebral infarction (stroke)
- Thrombotic microangiopathy and hemolytic uremic syndrome
- Cerebral arteritis
- Raynaud’s phenomenon
- Arterial thrombosis, deep vein thrombosis
- Impaired liver function
- Scleroderma (hardening of connective tissue)
Very Rare
- Tumor lysis syndrome (metabolic emergency from rapid tumor breakdown)
Frequency Not Known
- Severe infection (sepsis)
- Pancytopenia (severe reduction in all blood cell types)
- Anemia (low red blood cells)
Skin and mucous membrane reactions are the most frequently observed side effects of bleomycin, occurring in up to 50% of treated patients. These include redness, rash, itching, ulceration, skin striae and blistering, pronounced pigmentation changes, and tenderness of the fingertips. The characteristic skin pigmentation – often described as “flagellate” hyperpigmentation appearing as linear streaks – is a hallmark of bleomycin therapy and typically resolves after treatment is completed.
Fever on the day of injection is common and is usually the earliest adverse reaction observed. Other early effects include decreased appetite, chills, fatigue, and pain at the injection site or at the tumor. Local thrombophlebitis (inflammation of a vein) may occur after intravenous administration.
How Should You Store Bleomycin Accord?
Bleomycin Accord must be stored in a refrigerator at 2°C to 8°C and kept out of the sight and reach of children. After reconstitution, the solution is stable for up to 10 days at 2°C to 8°C and 48 hours at room temperature, but should ideally be used immediately.
Proper storage of bleomycin is essential to ensure the drug remains effective and safe for use. As a hospital-administered medication, storage is typically managed by pharmacy staff, but patients receiving treatment should be aware of the following guidelines:
- Store in a refrigerator (2°C to 8°C) in the original packaging
- Do not use after the expiry date printed on the carton and vial (the expiry date refers to the last day of the stated month)
- After reconstitution: Chemically and physically stable for 10 days at 2°C to 8°C and 48 hours at room temperature. From a microbiological standpoint, the product should be used immediately.
- Single use only – any unused solution must be discarded
- Do not use if you notice visible signs of deterioration such as discoloration of the powder or damage to the vial or seal
- Dispose of unused medicine according to local regulations for cytotoxic waste – do not dispose of via household waste or sewage systems
What Does Bleomycin Accord Contain?
Each vial of Bleomycin Accord contains 15,000 IU of bleomycin (as bleomycin sulfate) as the active ingredient. The only other ingredients are sodium hydroxide and hydrochloric acid used for pH adjustment. The product is essentially sodium-free.
Bleomycin Accord contains the following components:
- Active substance: Bleomycin (as bleomycin sulfate) – 15,000 International Units (IU) per vial
- Other ingredients: Sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment)
- Sodium content: This medicine contains less than 1 mmol sodium (23 mg) per dose, meaning it is essentially sodium-free
Appearance and Packaging
Bleomycin Accord is supplied as a white to pale yellow freeze-dried powder in a clear Type I glass vial with a bromobutyl rubber stopper sealed with an aluminum flip-off cap. When reconstituted with normal saline, it forms a clear, pale yellow solution. Available in pack sizes of 1, 10, and 100 vials. Not all pack sizes may be marketed in all countries.
The marketing authorization holder is Accord Healthcare B.V., based in Utrecht, the Netherlands, and the product is manufactured by Accord Healthcare Polska Sp.z.o.o. in Pabianice, Poland.
Frequently Asked Questions About Bleomycin Accord
Bleomycin Accord is a cytotoxic chemotherapy drug used to treat several types of cancer. Its main indications include squamous cell carcinoma of the head and neck, cervix, and external genitalia; Hodgkin lymphoma (often as part of the ABVD regimen); intermediate and high-grade non-Hodgkin lymphoma; testicular cancer (commonly as part of the BEP regimen); and malignant pleural effusions. It works by causing breaks in the DNA of cancer cells, preventing them from dividing and growing.
The most serious side effect of bleomycin is pulmonary toxicity, which includes interstitial pneumonitis and pulmonary fibrosis. This can be fatal if not detected early. The risk increases with cumulative doses above 400,000 IU, age over 60, prior or concurrent radiation to the chest, reduced kidney function, and exposure to high concentrations of oxygen. Warning signs include persistent cough, shortness of breath, and crackling sounds when breathing. Regular lung function monitoring is essential during treatment.
A test dose is given before the first bleomycin treatment, especially for lymphoma patients, because of the risk of severe idiosyncratic hypersensitivity reactions that can resemble anaphylaxis. These reactions can occur immediately or several hours after administration. The test dose is typically 1,000–2,000 IU, and the patient is observed for at least 4 hours for any signs of an allergic reaction, such as wheezing, breathing difficulties, facial swelling, or widespread rash. If no reaction occurs, full-dose therapy can begin.
No, bleomycin should not be used during pregnancy, especially in the first trimester. Animal studies have shown that the drug can cause fetal harm. If treatment is absolutely necessary during pregnancy, the risks must be carefully discussed with the healthcare team. Both men and women must use reliable contraception during bleomycin treatment and for at least 6 months after the last dose. Men wishing to have children in the future should consider sperm banking before starting treatment, as bleomycin may cause permanent infertility.
The maximum cumulative lifetime dose of bleomycin depends on the patient’s age and condition. For patients under 60, the general limit is 400,000 IU (225,000 IU/m² body surface area). For lymphoma patients, the maximum is 225,000 IU regardless of age. For patients aged 60–69, the limit is 200,000–300,000 IU; for ages 70–79, it is 150,000–200,000 IU; and for patients 80 and over, the maximum is 100,000 IU. Exceeding these limits significantly increases the risk of potentially fatal pulmonary fibrosis.
High concentrations of supplemental oxygen, particularly during general anesthesia, can trigger severe and potentially fatal pulmonary toxicity in patients who have received bleomycin. The mechanism involves bleomycin-generated free radicals in lung tissue, which are amplified by high oxygen levels, leading to acute respiratory distress syndrome (ARDS). This risk can persist for years after the last bleomycin dose. It is critical that patients always inform their healthcare providers – especially anesthesiologists – about their bleomycin treatment history, so that inspired oxygen concentrations can be kept to the minimum necessary.
References
This article is based on the following peer-reviewed sources and international medical guidelines:
- European Medicines Agency (EMA). Summary of Product Characteristics: Bleomycin. Updated 2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List. Geneva: WHO; 2023.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Hodgkin Lymphoma. Version 2.2025.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Testicular Seminoma and Non-seminoma. Updated 2024.
- Hay J, Shahzeidi S, Laurent G. Mechanisms of bleomycin-induced lung damage. Arch Toxicol. 1991;65(2):81-94.
- Sleijfer S. Bleomycin-induced pneumonitis. Chest. 2001;120(2):617-624. doi:10.1378/chest.120.2.617
- Reinert T, Baldotto CSR, Nunes FAP, Scheliga AAS. Bleomycin-induced lung injury. J Cancer Res. 2013;2013:480608.
- British National Formulary (BNF). Bleomycin Monograph. National Institute for Health and Care Excellence (NICE). 2025.
- U.S. Food and Drug Administration (FDA). Bleomycin Sulfate Prescribing Information. FDA Label.
- Doll DC, Ringenberg QS, Yarbro JW. Vascular toxicity associated with antineoplastic agents. J Clin Oncol. 1986;4(9):1405-1417.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of specialist physicians with expertise in clinical pharmacology, medical oncology, and internal medicine. Our editorial process follows international medical standards (WHO, EMA, FDA, ESMO, NCCN) and the GRADE evidence framework.
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