bleomycin (Rx)Brand and Other Names:Blenoxane

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 15unit
  • 30unit
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Squamous Cell Carcinoma

0.25-0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC q1-2Weeks 

Hodgkin's Disease, Non-Hodgkin's 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

bleomycin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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 rxns

            Onycholysis

            Pruritus

            Skin thickening

            Skleroderma

            <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

            Concomitant use of bleomycin with brentuximab because of pulmonary toxicity

            Cautions

            Use cautioin in renal impairment

            Hepatic toxicity reported

            Use caution when administering oxygen during surgery (increases risk of pulmonary toxicity)

            Risk of pulmonary fibrosis (at lower doses if used with other antineoplastics)

            Avoid pregnancy

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: It is not known whether the drug is excreted in milk. Because of the potential for serious adverse reactions in nursing infants, it is 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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            Formulary

            FormularyPatient Discounts

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            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.
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            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
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