bleomycin (Rx)

Brand and Other Names:Blenoxane

Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and bleomycin

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            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)

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              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

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              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

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              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.

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              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%)

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              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)

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              bleomycin injection
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              30 unit vial
              bleomycin injection
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              15 unit vial
              bleomycin injection
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              bleomycin injection
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              15 unit vial
              bleomycin injection
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              bleomycin injection
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              30 unit vial
              bleomycin injection
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              15 unit vial
              bleomycin injection
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              15 unit vial
              bleomycin injection
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              15 unit vial
              bleomycin injection
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              30 unit vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              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.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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              • View the formulary and any restrictions for each plan.
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              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.