Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 15unit
- 30unit
Squamous Cell Carcinoma
0.25-0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC q1-2Weeks
Hodgkin Disease, Non-Hodgkin Lymphoma
Administer test dose of 1-2 units of bleomycin before first 1-2 doses; monitor vital signs q15min; wait 1 hour minimum before administering remainder of dose; if no acute reaction observe, may administer regular dosage schedule
0.25 to 0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC q1-2Weeks; reduce to maintenance dose of 1 unit qDay or 5 unit qWeek IV/IM after 50% response
Testicular Carcinoma
0.25-0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC q1-2Weeks
Pleural Sclerosing
60 unit in 50-100 mL as single instillation; may repeat dose at intervals of several days if fluid continues to accumulate (mix in 50-100 mL or NS); may add lidocaine 100-200 mg to reduce local discomfort
Elderly: May limit dose to 40 unit/m²
Pancreatic Cancer (Orphan)
Treatment of pancreatic cancer
Orphan indication sponsors
- Genetronics, Inc; 11199 Sorrento Valley Rd; San Diego, CA 92121-1334
- CIRJ Company Ltd; 1800 Loma Vista St; Pasadena, CA 91004
Renal Impairment
CrCl >50 mL/min: Dose adjustment not necessary
CrCl 40-50 mL/min: 70% of normal dose
CrCl 30-40 mL/min: 60% of normal dose
CrCl 20-30 mL/min: 55% normal dose
CrCl 10-20 mL/min: 45% normal dose
CrCl 5-10 mL/min: 40% normal dose
Hepatic Impairment
Dose adjustment not necessary
Monitor
Chest X-ray q1-2Weeks
Administration
In lymphoma patients, give first 2 doses at 1-2 units to test for anaphylactoid reaction
Limit lifetime dose to <400 units because of risk of pulmonary fibrosis
Low ADRs w/intrapleural administration
Not recommended
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- brentuximab vedotin
brentuximab vedotin and bleomycin both increase Other (see comment). Contraindicated. Contraindicated because of increased risk of pulmonary toxicity.
Serious - Use Alternative (4)
- adenovirus types 4 and 7 live, oral
bleomycin decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- influenza virus vaccine quadrivalent, adjuvanted
bleomycin decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
bleomycin decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- palifermin
palifermin increases toxicity of bleomycin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
Monitor Closely (13)
- cholera vaccine
bleomycin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
bleomycin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- ethotoin
bleomycin decreases levels of ethotoin by increasing metabolism. Use Caution/Monitor.
- fosphenytoin
bleomycin decreases levels of fosphenytoin by increasing metabolism. Use Caution/Monitor.
- meningococcal group B vaccine
bleomycin decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, bleomycin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
bleomycin and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- oxaliplatin
oxaliplatin and bleomycin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.
- phenytoin
bleomycin decreases levels of phenytoin by increasing metabolism. Use Caution/Monitor.
- siponimod
siponimod and bleomycin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- tenofovir DF
bleomycin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- trastuzumab
trastuzumab, bleomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, bleomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
Minor (0)
Adverse Effects
>10%
Mucocutaneous toxicity including rash, erythema, hyperpigmentation, urticaria (>50%)
Febrile reactions, acute (25-50%)
Mucositis (30%)
Stomatitis (30%)
Interstitial pneumonitis (10%)
Pulmonary fibrosis (10%)
Anorexia
Weight loss
Rales
Tachypnea
1-10%
Alopecia (1-10%)
Fatal pulmonary fibrosis (1%)
Confusion
Shivering
Anphylactoid reactions
Onycholysis
Pruritus
Skin thickening
Scleroderma
<1%
Nausea
Malaise
Myocardial infarction
Hypotension
Cerebral vascular accident
Raynaud's phenomenon
Fatal pulmonary fibrosis
Hepatotoxicity
Renal toxicity
Necrolysis
Hyperpigmentation
Warnings
Black Box Warnings
Severe idiosyncratic reactions including hypotension, confusion, fever, chills, and wheezing occurring usually after the first or second dose have been reported.
Monitoring is very important after administering these doses.
Pneumonitis that progresses to pulmonary fibrosis is the most severe toxicity reported. Risk increases in elderly persons and with doses >400 units.
The drug should be administered under the supervision of an experienced cancer chemotherapy physician.
Contraindications
Hypersensitivity
Cautions
Patients receiving therapy must be observed carefully and frequently during and after therapy; it should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function
Pulmonary toxicities occur in 10% of treated patients; in approximately 1%, the nonspecific pneumonitis induced by bleomycin progresses to pulmonary fibrosis and death; although this is age and dose-related, the toxicity is unpredictable; frequent roentgenograms recommended
A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion, fever, chills, and wheezing reported in approximately 1% of lymphoma patients receiving therapy; since these reactions usually occur after first or second dose, careful monitoring is essential after these doses
Renal or hepatic toxicity, beginning as deterioration in renal or liver function tests, reported; these toxicities may occur at any time after initiation of therapy
Patients with creatinine clearance values of < 50 mL/min should be treated with caution and their renal function should carefully monitored during the administration; lower doses of bleomycin may be required in these patients than those with normal renal function
Pregnancy & Lactation
Pregnancy
Therapy can cause fetal harm when administered to a pregnant woman; there have been no studies on pregnant women
If injection is used during pregnancy, or if patient becomes pregnant while receiving this drug, the patient should be apprised of potential hazard to fetus
Women of childbearing potential should be advised to avoid becoming pregnant during therapy
Animal data
- Has been shown to be teratogenic in rats; administration of intraperitoneal doses of 1.5 mg/kg/day to rats (about 1.6 times the recommended human dose on a unit/m2 basis) on days 6 to 15 of gestation caused skeletal malformations, shortened innominate artery and hydroureter
- This drug is abortifacient but not teratogenic in rabbits at intravenous doses of 1.2 mg/kg/day (about 2.4 times the recommended human dose on a unit/m2 basis) given on gestation days 6 to 18
Lactation
Not known whether the drug is excreted in human milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants, recommended that nursing be discontinued by women receiving bleomycin therapy
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Glycopeptide antibiotic; inhibits DNA, RNA, protein synthesis in G2, M phases
Pharmacokinetics
Half-Life: 2 hr
Protein Bound: 1%
Vd: 17 L/m²
Metabolism: Unknown
Metabolites: Bleomycin-iron complex
Clearance: 35 mL/min
Excretion: Urine (50-70%)
Administration
IV Incompatibilities
Solution: D5W
Additive: aminophylline, ascorbic acid injection, cefazolin, diazepam, hydrocortisone sodium succinate, methotrexate, mitomycin, nafcillin, penicillin G sodium, terbutaline
IV Compatibilities
Solution: NS
Additive (partial list): diphenhydramine, fluorouracil, heparin, hydrocortisone Na-phosphate
Syringe (partial list): cisplatin, furosemide, heparin, methotrexate, metoclopramide, mitomycin
Y-site (partial list): allopurinol, cisplatin, etoposide PO4, gemcitabine, heparin, metoclopramide, mitomycin, ondansetron, paclitaxel
IV/IM Preparation
IV: reconstitute 15 U vial in 5 mL & 30 U vial in 10 mL NS to yield 3 U/mL solution
IM/SC: reconstitute 15 U vial in 1-5 mL & 30 U vial in 2-10 mL NS/SWI/BWI
Do not use dextrose-containing diluents
Although may be stable for longer periods, preferably use within 24 hr of reconstitution
IV/IM Administration
IM/SC: may cause pain at injection site
IV: may be irritant; administer by slow inj over 10 min; pH: 4.5-6.0
Storage
Refrigerate intact vials of powder; stable under refrigeration (2-8°C)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| bleomycin injection - | 30 unit vial |  | |
| bleomycin injection - | 15 unit vial |  | |
| bleomycin injection - | 30 unit vial |  | |
| bleomycin injection - | 15 unit vial |  | |
| bleomycin injection - | 30 unit vial |  | |
| bleomycin injection - | 30 unit vial |  | |
| bleomycin injection - | 15 unit vial |  | |
| bleomycin injection - | 15 unit vial |  | |
| bleomycin injection - | 15 unit vial |  | |
| bleomycin injection - | 30 unit vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
bleomycin injection
BLEOMYCIN - INJECTION
(BLEE-oh-MY-sin)
COMMON BRAND NAME(S): Blenoxane
WARNING: Rarely, bleomycin can cause a serious, allergic-like reaction. It is most common in lymphoma patients. Before your main treatment with this drug begins, your doctor may direct you to receive a smaller test dose to check for signs of this serious reaction. Tell your doctor right away if any of the following serious side effects occur: dizziness/fainting, confusion, fever, chills, trouble breathing.Severe (sometimes fatal) lung problems (lung scarring) have rarely occurred in patients using this drug. This reaction is more likely in patients older than 70 years. The risk of this reaction increases as you receive more doses of this drug. This problem may occur anytime during treatment. Tell your doctor right away if you experience any of these serious side effects: cough, fever, chills, chest pain, or difficult/painful breathing.
USES: Bleomycin is used to treat cancer. It works by slowing or stopping the growth of cancer cells.This medication may also be used to control the build-up of fluid around the lungs (pleural effusion) caused by tumors that have spread to the lungs. For this condition, bleomycin is placed in the space around the lungs through a chest tube.
HOW TO USE: This medication is given by injection into a vein, into a muscle, or under the skin by a health care professional. It is given as directed by your doctor, usually once or twice a week. When giving this medication into a vein, it is injected slowly over 10 minutes. Tell your health care professional right away if you experience any chest pain. The medication may need to be stopped or injected more slowly. The dosage is based on your medical condition, body size, and response to treatment.If you are receiving this medication through a chest tube into the space around the lungs, the solution is usually left in place for 4 hours and then drained out through the chest tube. Your doctor may direct you to change positions during the 4 hours to make sure the solution treats all parts of your lungs.
SIDE EFFECTS: See also Warning section.Pain/redness at the injection site, fever, chills, vomiting, loss of appetite, weight loss, darkening of the skin, or changes in fingernails/toenails may occur. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. In some cases, drug treatment may be necessary to prevent or relieve nausea and vomiting. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Painful sores on the lips, mouth, and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water.Bleomycin can commonly cause skin reactions (such as redness, itching, blisters, rash, swelling), usually in the second or third week of treatment. These reactions are not always serious. However, you may not be able to tell them apart from signs of a severe reaction. Tell your doctor right away if you develop any skin reaction.Tell your doctor right away if you have any serious side effects, including: nausea that doesn't stop, dizziness/fainting, fast/pounding heartbeat, numbness/tingling, feeling of coldness in hands/feet, easy bruising/bleeding, pale/bluish skin, coughing up blood, vomit that looks bloody or like coffee grounds, signs of infection (such as sore throat that doesn't go away), signs of kidney problems (such as change in the amount of urine, pink urine), mental/mood changes (such as confusion, aggression), stomach/abdominal pain, dark urine, yellowing eyes/skin.Get medical help right away if you have any very serious side effects, including: weakness on one side of the body, vision changes, trouble speaking, chest pain.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: confusion, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using bleomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially: immune system problems (such as chemotherapy, bone marrow problems), kidney disease, liver disease, lung problems.This medication may make your lungs more sensitive to oxygen treatment. Tell your doctor or dentist that you have used this medication before having surgery or any treatment where oxygen may be used.Older adults may be at greater risk for side effects (such as lung problems) while using this drug.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using bleomycin. Bleomycin may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: brentuximab, digoxin, drugs that may harm the kidneys (for example, aminoglycosides such as gentamicin, cisplatin), phenytoin.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as chest X-rays, complete blood counts, kidney/liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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