Bleomycin

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses.
• If no acute reaction occurs, then the regular dosage schedule may be followed.
• The following dose schedule is recommended:
• Squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma – 0.25 to 0.5 units/kg (10 to 20 units/m 2 ) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
• Hodgkin's Disease – 0.25 to 0.5 units/kg (10 to 20 units/m 2 ) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
• After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
• Pulmonary toxicity of bleomycin for injection appears to be dose-related with a striking increase when the total dose is over 400 units.
• Total doses over 400 units should be given with great caution.
• Note:
• When bleomycin for injection is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
• Improvement of Hodgkin's disease and testicular tumors is prompt and noted within 2 weeks.
• If no improvement is seen by this time, improvement is unlikely.
• Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
• Malignant Pleural Effusion – 60 units administered as a single dose bolus intrapleural injection (see ADMINISTRATION:
• Intrapleural ).
• Use in Patients with Renal Insufficiency The following dosing reductions are proposed for patients with creatinine clearance (CrCL) values of less than 50 mL/min:
• CrCL can be estimated from the individual patient's measured serum creatinine (Scr) values using the Cockcroft and Gault formula:
• Males CrCL = [weight × (140 – Age)]/(72 × Scr) Females CrCL = 0.85 × [weight × (140 – Age)]/(72 × Scr) Where CrCL in mL/min/1.73m 2 , weight in kg, age in years, and Scr in mg/dL.
• Patient CrCL (mL/min) Bleomycin for Injection Dose (%) 50 and above 100 40 to 50 70 30 to 40 60 20 to 30 55 10 to 20 45 5 to 10 40

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Use in children

Safety and effectiveness of bleomycin in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger patients (see BOXED WARNING , WARNINGS, and ADVERSE REACTIONS:
• Pulmonary ).
• Other reported clinical experience has not identified other differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
• Bleomycin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
• Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Quoted from the official label, section “Geriatric Use”.

Side effects

• Pulmonary The most serious side effects are pulmonary adverse reactions, occurring in approximately 10% of treated patients.
• The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis.
• Approximately 1% of patients treated have died of pulmonary fibrosis.
• Pulmonary toxicity is both dose and age related, being more common in patients over 70 years of age and in those receiving over 400 units total dose.
• This toxicity, however, is unpredictable and has been seen in young patients receiving low doses.
• Some published reports have suggested that the risk of pulmonary toxicity may be increased when bleomycin is used in combination with G-CSF (filgrastim) or other cytokines.
• However, randomized clinical studies completed to date have not demonstrated an increased risk of pulmonary complications in patients treated with bleomycin and G-CSF.
• Because of lack of specificity of the clinical syndrome, the identification of patients with pulmonary toxicity due to bleomycin has been extremely difficult.
• The earliest symptom associated with bleomycin pulmonary toxicity is dyspnea.
• The earliest sign is fine rales.
• Radiographically, bleomycin-induced pneumonitis produces nonspecific patchy opacities, usually of the lower lung fields.
• The most common changes in pulmonary function tests are a decrease in total lung volume and a decrease in vital capacity.
• However, these changes are not predictive of the development of pulmonary fibrosis.
• The microscopic tissue changes due to bleomycin toxicity include bronchiolar squamous metaplasia, reactive macrophages, atypical alveolar epithelial cells, fibrinous edema, and interstitial fibrosis.
• The acute stage may involve capillary changes and subsequent fibrinous exudation into alveoli producing a change similar to hyaline membrane formation and progressing to a diffuse interstitial fibrosis resembling the Hamman-Rich syndrome.
• These microscopic findings are nonspecific; e.g., similar changes are seen in radiation pneumonitis and pneumocystic pneumonitis.
• To monitor the onset of pulmonary toxicity, roentgenograms of the chest should be taken every 1 to 2 weeks (see WARNINGS ).
• If pulmonary changes are noted, treatment should be discontinued until it can be determined if they are drug related.
• Recent studies have suggested that sequential measurement of the pulmonary diffusion capacity for carbon monoxide (DL co ) during treatment with bleomycin may be an indicator of subclinical pulmonary toxicity.
• It is recommended that the DL co be monitored monthly if it is to be employed to detect pulmonary toxicities, and thus the drug should be discontinued when the DL co falls below 30% to 35% of the pretreatment value.
• Because of bleomycin's sensitization of lung tissue, patients who have received bleomycin are at greater risk of developing pulmonary toxicity when oxygen is administered in surgery.
• While long exposure to very high oxygen concentrations is a known cause of lung damage, after bleomycin administration, lung damage can occur at lower concentrations that are usually considered safe.
• Suggested preventive measures are:
• Maintain FIO 2 at concentrations approximating that of room air (25%) during surgery and the postoperative period.
• Monitor carefully fluid replacement, focusing more on colloid administration rather than crystalloid.
• Sudden onset of an acute chest pain syndrome suggestive of pleuropericarditis has been reported during bleomycin infusions.
• Although each patient must be individually evaluated, further courses of bleomycin do not appear to be contraindicated.
• Pulmonary adverse events which may be related to the intrapleural administration of bleomycin have been reported.
• Idiosyncratic Reactions In approximately 1% of the lymphoma patients treated with bleomycin, an idiosyncratic reaction, similar to anaphylaxis clinically, has been reported.
• The reaction may be immediate or delayed for several hours, and usually occurs after the first or second dose (see WARNINGS ).
• It consists of hypotension, mental confusion, fever, chills, and wheezing.
• Treatment is symptomatic including volume expansion, pressor agents, antihistamines, and corticosteroids.
• Integument and Mucous Membranes These adverse reactions have been reported in approximately 50% of treated patients.
• They consist of erythema, rash, striae, vesiculation, hyperpigmentation, and tenderness of the skin.
• Hyperkeratosis, nail changes, alopecia, pruritus, and stomatitis have also been reported.
• It was necessary to discontinue bleomycin therapy in 2% of treated patients because of these toxicities.
• Scleroderma-like skin changes have been reported.
• Skin toxicity is a relatively late manifestation usually developing in the second and third week of treatment after 150 to 200 units of bleomycin have been administered and appears to be related to the cumulative dose.
• Intrapleural administration of bleomycin has been associated with local pain.
• Hypotension possibly requiring symptomatic treatment has been reported.
• Death has been reported in association with bleomycin pleurodesis in seriously ill patients.
• Other Vascular toxicities coincident with the use of bleomycin in combination with other antineoplastic agents have been reported.
• The events are clinically heterogeneous and may include myocardial infarction, cerebrovascular accident, thrombotic microangiopathy (HUS), or cerebral arteritis.
• Various mechanisms have been proposed for these vascular complications.
• There are also reports of Raynaud's phenomenon occurring in patients treated with bleomycin in combination with vinblastine with or without cisplatin or, in a few cases, with bleomycin as a single agent.
• It is currently unknown if the cause of Raynaud's phenomenon in these cases is the disease, underlying vascular compromise, bleomycin, vinblastine, hypomagnesemia, or a combination of any of these factors.
• Fever, chills, and vomiting have been reported.
• Anorexia and weight loss have been reported and may persist long after termination of this medication.
• Pain at tumor site, phlebitis, and other local reactions have been reported.
• Malaise has been reported.
• To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Healthcare at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

• Bleomycin for Injection, USP is supplied as follows:
• NDC Bleomycin for Injection, USP Package Factor 16714- 886 -01 15 units per vial 1 vial per carton 16714- 908 -01 30 units per vial 1 vial per carton Storage Conditions Store refrigerated between 2° and 8°C (36° and 46°F).
• The sterile powder is stable under refrigeration and should not be used after the expiration date is reached.
• Bleomycin for Injection, USP should not be reconstituted or diluted with D 5 W or other dextrose containing diluents.
• When reconstituted in D 5 W and analyzed by HPLC, Bleomycin for Injection, USP demonstrates a loss of A 2 and B 2 potency that does not occur when Bleomycin for Injection, USP is reconstituted in Sodium Chloride for Injection, 0.9%, USP.
• Bleomycin for Injection, USP is stable for 24 hours at room temperature in Sodium Chloride.
• Discard unused portion.
• Sterile, Nonpyrogenic, Preservative-free.
• The container closure is not made with natural rubber latex.

Quoted from the official label, section “How Supplied”.

How to store it

• Conditions Store refrigerated between 2° and 8°C (36° and 46°F).
• The sterile powder is stable under refrigeration and should not be used after the expiration date is reached.
• Bleomycin for Injection, USP should not be reconstituted or diluted with D 5 W or other dextrose containing diluents.
• When reconstituted in D 5 W and analyzed by HPLC, Bleomycin for Injection, USP demonstrates a loss of A 2 and B 2 potency that does not occur when Bleomycin for Injection, USP is reconstituted in Sodium Chloride for Injection, 0.9%, USP.
• Bleomycin for Injection, USP is stable for 24 hours at room temperature in Sodium Chloride.
• Discard unused portion.
• Sterile, Nonpyrogenic, Preservative-free.
• The container closure is not made with natural rubber latex.

Quoted from the official label, section “Storage and Handling”.

What is in it

• Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus .
• It is freely soluble in water.
• Bleomycin for Injection, USP is provided as a sterile lyophilized powder for reconstitution containing 15 units per vial and 30 units per vial, which are intended for intramuscular, intravenous, subcutaneous or intrapleural administration.
• Its chemical name is N'-[3-(dimethylsulphonio)propyl]bleomycin-amide (bleomycin A 2 ) and N'-[4-(guaniodobutyl)]bleomycin-amide (bleomycin B 2 ).
• (Main component:
• Bleomycin A 2 , in which R is [CH 3 ] 2 S + CH 2 CH 2 CH 2 -) Note:
• A unit of bleomycin is equal to the formerly used milligram activity.
• The term milligram activity is a misnomer and was changed to units to be more precise.
• Chemical Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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