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Blenoxane

Generic Name: Bleomycin Sulfate
Class: Antineoplastic Agents
VA Class: AN200
CAS Number: 9041-93-4

Warning(s)

  • Administer only under supervision of qualified clinicians experienced in use of cytotoxic therapy and only in a setting where adequate diagnostic and treatment facilities are readily available.121

  • Risk of developing pulmonary toxicity (e.g., pneumonitis, pulmonary fibrosis), particularly in geriatric patients >70 years of age and in patients receiving total bleomycin dosage >400 units.121 (See Pulmonary Toxicity under Cautions.)

  • Risk of severe idiosyncratic reaction (e.g., hypotension, mental confusion, fever, chills, wheezing) in patients with Hodgkin’s or non-Hodgkin’s disease.121 (See Sensitivity Reactions under Cautions.)

Introduction

Antineoplastic agent; mixture of basic cytotoxic glycopeptide antibiotics produced by Streptomyces verticillus (bleomycin A2 and bleomycin B2 are the major components).121

Uses for Blenoxane

Hodgkin’s Disease

Treatment of Hodgkin’s disease.121 122 142 143 144 217

Combination therapy for induction of remissions is superior to single-drug therapy.142 143 144

Various combination regimens are used.142 143 144

Commonly used in combination with doxorubicin, vinblastine, and dacarbazine (ABVD regimen).121 122 142 143 144 217

Non-Hodgkin’s Disease

Has been used for treatment of non-Hodgkin’s lymphoma.121 122

Second- or third-generation combination regimens containing bleomycin no more effective than the standard CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) for the treatment of advanced intermediate-grade or high-grade non-Hodgkin’s lymphoma.235 236 237 238 239

Testicular Cancer

Treatment of testicular embryonal cell carcinoma, choriocarcinoma, and teratocarcinoma.121 123 126 127 128 129 130 132 140

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Combination chemotherapy with bleomycin, cisplatin, and etoposide is a regimen of choice for the treatment of advanced nonseminomatous testicular carcinoma.122 123 126 127 128 129 130 132

Combination chemotherapy with bleomycin, cisplatin, and etoposide is used for the treatment of disseminated seminoma testis.123 128 129 131 132 140

Pleural Effusions

Intracavitary injection as a sclerosing agent for intrapleural management and prevention of recurrent pleural effusions (pleurodesis) caused by metastatic tumors.121

At least as effective and possibly better tolerated than intrapleural tetracycline.121 147 148 149 151 154 155 156

Intrapleural talc may be preferred because of cost considerations.c d e f g

Has been used for intrapleural management of pneumothorax associated with AIDS Pneumocystis jiroveci (Pneumocystis carinii) pneumonia.108 112

Head and Neck Cancer

Palliative treatment of squamous cell carcinomas of the head and neck (including mouth, tongue, tonsils, nasopharynx, oropharynx, sinuses, palate, lip, buccal mucosa, gingiva, epiglottis, larynx, skin).121

Poorer response to bleomycin in patients who have received prior radiation therapy for the treatment of head and neck cancer.121

Combination chemotherapy with cisplatin, methotrexate, and vincristine for advanced head and neck cancer.122 225

Cervical Cancer

Has been used for palliative treatment of squamous cell carcinoma of the cervix.121

Not considered a drug of choice for the treatment of advanced cervical cancer.232

Penile or Vulval Cancer

Palliative treatment of squamous cell carcinomas of the penis and vulva (in combination with other antineoplastic agents).121 234

AIDS-related Kaposi’s Sarcoma

Has been used for the palliative treatment of AIDS-related Kaposi’s sarcoma (alone or in combination with doxorubicin, and a vinca alkaloid).122 146 172 173 174 175 176 177

Has been used as monotherapy for palliative treatment of early-stage disease.146 169 170 171

Bleomycin combination chemotherapy has been considered a regimen of choice for advanced disease,122 146 175 177 but a liposomal anthracycline currently considered first-line therapy.146 185

Ovarian Cancer

Has been used for the treatment of ovarian germ cell tumors (in combination with cisplatin and etoposide).122 216

Intracranial Germ Cell Tumors

Has been used for the treatment of intracranial germ cell tumors (in combination with cisplatin and vinblastine).122 178

Blenoxane Dosage and Administration

General

  • Individualize dosage carefully according to individual requirements and response.121

  • Consult specialized references for procedures for proper handling and disposal of antineoplastics.121

Sensitivity Testing

  • Risk of anaphylactoid reactions in lymphoma patients (e.g., those with Hodgkin’s and non-Hodgkin’s disease).121

  • Administer 2 test doses (i.e., ≤2 units of bleomycin) before initiating full-dose therapy.121

  • After each test dose, monitor carefully for severe idiosyncratic reactions (see Boxed Warning).121 If no acute reaction occurs, recommended dosage regimen may then be administered.121

  • Take precautions to treat potential allergic reactions.121

Premedication

  • Intrapleural injection of local anesthetics or systemic administration of opiates prior to the intrapleural procedure may relieve pain associated with pleurodesis104 120 153 160 163 164 166 but generally are not considered necessary.121

Administration

Administer by IV, IM, sub-Q, or intrapleural (intracavitary) injection.121

IV Administration

Administer by IV injection once or twice weekly.121

For solution and drug compatibility information, see Compatibility under Stability.

Reconstitution

Add a minimum of 5 or 10 mL of 0.9% sodium chloride injection to the vial labeled as containing 15 or 30 units, respectively, to provide a solution containing not more than 3 units/mL.121

Rate of Administration

Administer IV slowly over a 10-minute period.121

IM Administration

Administer by IM injection once or twice weekly.121

Reconstitution

Add 1–5 or 2–10 mL of sterile water for injection, 0.9% sodium chloride injection, or bacteriostatic water for injection to the vial containing 15 or 30 units, respectively, to provide solutions containing 3–15 units/mL.121

Sub-Q Administration

Administer by sub-Q injection once or twice weekly.121

Reconstitution

Add 1–5 or 2–10 mL of sterile water for injection, 0.9% sodium chloride injection, or bacteriostatic water for injection to the vial containing 15 or 30 units, respectively, to provide solutions containing 3–15 units/mL.121

Intrapleural Administration

Administer as a single bolus dose by intrapleural (intracavitary) injection through a thoracostomy tube.121

Drain pleural fluid via the thoracostomy by gravity or suction prior to instillation;102 103 104 110 118 119 120 121 confirmation of complete expansion of the lungs is recommended.121 148 153

Initiate therapy when chest tube drainage <100 mL in a 24 hour period or 100–300 mL in 24 hours under certain special circumstances.121

Reconstitution

Dissolve 60 units in 50–100 mL of 0.9% sodium chloride injection.121

Dosage

Available as bleomycin sulfate; dosage expressed in terms of bleomycin.121

Consult published protocols for the dosage of bleomycin and other chemotherapeutic agents and the method and sequence of administration.121

Adults

Hodgkin’s Disease

Increased sensitivity risk in lymphomas; administer test doses.121 (See Sensitivity Testing under Dosage and Administration.)

IV, IM, or Sub-Q

0.25–0.5 units/kg (10–20 units/m2) once or twice weekly.121

Following a 50% regression of tumor size, a maintenance dose of 1 unit daily or 5 units weekly can be given.121

Improvement unlikely to occur if not evident by week 2 of therapy.121

Non-Hodgkin’s Lymphoma

Increased sensitivity risk in lymphomas; administer test doses.121 (See Sensitivity Testing under Dosage and Administration.)

IV, IM, or Sub-Q

0.25–0.5 units/kg (10–20 units/m2) once or twice weekly.121

Testicular Cancer
IV, IM, or Sub-Q

0.25–0.5 units/kg (10–20 units/m2) once or twice weekly.121

Improvement in testicular cancer disease unlikely to occur if not evident by week 2 of therapy.121

Squamous Cell Carcinomas
IV, IM, or Sub-Q

0.25–0.5 units/kg (10–20 units/m2) once or twice weekly.121

Improvement in squamous cell carcinomas may not be evident for 3 weeks after initiation of therapy.121

Pleural Effusions
Intrapleural

50–60 units diluted and instilled into the chest through a thoracostomy tube followed by clamping of the tube, periodic rotation (optional)148 149 of the patient during the next 4 hours, and subsequent removal of the fluid.101 104 105 107 110 113 118 119 120 121

Length of time the chest tube remains in the pleural space after instillation of the drug should be individualized depending on the clinical status of the patient;121 allowing the chest tube to remain for at least 4 days after instillation may prevent pneumothorax.153

Dosage Modification for Toxicity

Contraindications to Continued Therapy121133

Pulmonary:

Clinical manifestations or radiologic evidence of pulmonary toxicity unless drug excluded as cause

Pulmonary diffusion capacity for carbon monoxide (DLco) <30–35% of the pretreatment value

Cardiovascular:

Intractable pain or ECG changes suggestive of pericarditis

Reduce Infusion Rate or Discontinue121133

Dermatologic:

Mucocutaneous toxicity (e.g., erythema, rash, striae, vesiculation, hyperpigmentation, and skin tenderness)

Pulmonary:

Rapid decline in forced vital capacity

Cardiovascular:

Acute chest pain syndrome suggestive of pleuropericarditis

Further courses of bleomycin therapy do not appear to be contraindicated, but careful evaluation of the patient must precede continuation of therapy.121

Prescribing Limits

Adults

IV, IM, or Sub-Q

Pulmonary toxicity: Administer cumulative dosages >400 units with great caution.121

When bleomycin is used in conjunction with other antineoplastic agents, pulmonary toxicity may occur at lower cumulative dosages of bleomycin.121

Intrapleural

Generally, maximum of 1 unit/kg or 40 units/m2 in geriatric patients.b

Special Populations

Renal Impairment

No dosage adjustment established by manufacturer for mild to moderate renal impairment; use with extreme caution in severe renal impairment.121

Cautions for Blenoxane

Contraindications

  • Known hypersensitivity or idiosyncrasy to bleomycin or any ingredient in the formulation.121

Warnings/Precautions

Warnings

Patient Monitoring

Has a low therapeutic index; monitor patients carefully and frequently during and after therapy.121

Sensitivity Reactions

Severe Idiosyncratic Reactions

Potentially life-threatening, severe idiosyncratic (anaphylactoid) reactions (see Boxed Warning);121 may be immediate or delayed for several hours, and usually occurs after the first or second dose.121 Monitor carefully.121 (See Sensitivity Testing under Dosage and Administration.)

Treatment of anaphylactoid reactions is supportive and symptomatic and may include volume expansion, vasopressor therapy, antihistamines, and corticosteroids.121

Major Toxicities

Pulmonary Toxicity

Risk of dose- and age-related pulmonary toxicity (see Boxed Warning); use with extreme caution in compromised pulmonary function.121

Most severe toxicity.121

Pneumonitis can progress to potentially fatal pulmonary fibrosis.121

Most frequently with total dosages >400 units, but can occur with lower dosages.121

Risk may be increased with filgrastim or other cytokines.121

Dyspnea and fine rales are early manifestations.121

Perform chest radiographs every 1–2 weeks and sequential measurement of pulmonary diffusion capacity for carbon monoxide (DLco) monthly during therapy.121

Dosage modification or drug discontinuance may be necessary.121 (See Dosage Modification for Toxicity under Dosage and Administration.)

Cardiovascular Toxicity

Risk of pleuropericarditis and/or vascular toxicities (e.g., MI, cerebrovascular accident, thrombotic microangiography, cerebral arteritis).121

Sudden onset of acute chest pain may be first sign of pleuropericarditis.121

Dosage modification may be necessary in patients experiencing acute chest pain syndrome suggestive of pleuropericarditis.121 133

Raynaud's phenomenon, possibly due to bleomycin, combination therapy (e.g., vinblastine, cisplatin), underlying cancer or vascular compromise, or combination of factors.121 134 135 136 137

Dermatologic and Mucocutaneous Toxicity

Risk of developing dose-related adverse mucocutaneous effects (e.g., erythema, rash, striae, vesiculation, hyperpigmentation, skin tenderness, and less commonly hyperkeratosis, nail changes, alopecia, pruritus, stomatitis).121

Usually occurs during the second or third week of bleomycin therapy after a cumulative dose of 150–200 units.121

Most frequent toxicity, occurring in 50% of patients.121

Discontinuance of bleomycin may be necessary.121

Renal and Hepatic Toxicity

Begins as deterioration in renal or liver function tests; may occur anytime after bleomycin initiation.121

Febrile Reactions

Fever and chills are frequent, mainly with large single doses within a few hours of administration and persisting for 4–12 hours.b

General Precautions

Surgery

Sensitizes lung tissue to damaging effects of oxygen administered during surgery; lung damage can occur at Fl O2 concentrations that are usually considered safe.121

Maintain Fl O2 at concentrations approximating that of room air (25%) during surgery and the postoperative period and monitor carefully fluid replacement, focusing more on colloid administration rather than crystalloid.121

Intrapleural Risks

Rarely, pulmonary toxicity.121

Local pain.121

Hypotension, which may require treatment.121

Very rarely, death, but patients were very seriously ill prior to treatment.121

Specific Populations

Pregnancy

Category D.121

Lactation

Not known whether bleomycin is distributed into milk.121 Use not recommended.121

Pediatric Use

Safety and efficacy not established in pediatric patients.121

Geriatric Use

Greater risk of pulmonary toxicity in patients >70 years of age than in younger patients.240

Titrate dosage carefully.240

Renal Impairment

Use with extreme caution in patients with clinically important renal impairment.121

Common Adverse Effects

With IV administration, fever, chills, vomiting, and anorexia/weight loss (which may persist long after discontinuance of therapy).121 Mucocutaneous and dermatologic effects are most common and pulmonary toxicity is most serious.121 (See Major Toxicities under Cautions.)

With intracavitary administration into the pleural space, chest pain and fever.104 121 147 148 150 153 159 160 161 166

Interactions for Blenoxane

Specific Drugs

Drug

Interaction

Comments

Antineoplastic agents

Increased risk of bleomycin-induced pulmonary toxicity121

Use with caution; pulmonary toxicity possible at lower total bleomycin dosages121

Filgrastim and other cytokines

Increased risk of bleomycin-induced pulmonary toxicity121

Use with caution; pulmonary toxicity possible at lower total bleomycin dosages121

Vitamins (e.g., vitamin C, riboflavin)

Bleomycin shown to be inactivated in vitro by ascorbic acid and riboflavin233

Blenoxane Pharmacokinetics

Absorption

Not appreciably absorbed orally; must be administered parenterally for systemic effect.121

Following intrapleural administration, systemic absorption is about 45%.121 150 153

Onset

Improvement in Hodgkin’s disease or testicular cancer usually evident within 2 weeks.121

Improvement in squamous cell carcinoma usually evident within 3 weeks.121

Distribution

Extent

Distributed mainly into skin, lungs, kidneys, peritoneum, and lymphatics in animals.121

Concentrations higher in tumor cells of skin and lungs relative to hematopoietic tissue.b

Elimination

Metabolism

Metabolic fate not determined.b

Elimination Route

Excreted principally in urine (60–70%) as active drug.b

Half-life

Clcr>35 mL/minute: serum or plasma terminal half-life of about 2 hours.121

Clcr<35 mL/minute: terminal half-life inversely related to creatinine clearance.121

Special Populations

Moderately severe renal impairment (Clcr <35 mL/minute) decreases renal clearance; accumulation may occur with severe renal impairment.112 121

Stability

Storage

Parenteral

Powder for Injection

2–8°C; do not use after the expiration date is reached.121

Reconstituted Solutions

Use reconstituted solutions stored at room temperature within 24 hours.121 b

Although stable for 2 weeks at room temperature or 4 weeks at 2–8°C, reconstituted solutions contain no preservatives; discard within 24 hours of reconstitution.b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Inactivated by agents containing sulfhydryl groups, hydrogen peroxide, and ascorbic acid.b

Forms Schiff base-type adducts with dextrose.106

Solution Compatibility

CompatibleHID 121

Sodium chloride 0.9%

Incompatible106 121

Dextrose 5% in water

Drug Compatibility
Admixture CompatibilityHID

Compatible

Amikacin sulfate

Dexamethasone sodium phosphate

Diphenhydramine HCl

Fluorouracil

Gentamicin sulfate

Heparin sodium

Hydrocortisone sodium phosphate

Streptomycin sulfate

Tobramycin sulfate

Vinblastine sulfate

Vincristine sulfate

Incompatible

Aminophylline

Ascorbic acid injection

Cefazolin sodium

Diazepam

Hydrocortisone sodium succinate

Methotrexate

Mitomycin

Nafcillin sodium

Penicillin G sodium

Terbutaline sulfate

Y-Site CompatibilityHID

Compatible

Allopurinol sodium

Amifostine

Aztreonam

Cefepime HCl

Cisplatin

Cyclophosphamide

Doxorubicin HCl

Doxorubicin HCl liposome injection

Droperidol

Etoposide phosphate

Filgrastim

Fludarabine phosphate

Fluorouracil

Gemcitabine HCl

Granisetron HCl

Heparin sodium

Leucovorin calcium

Melphalan HCl

Methotrexate sodium

Metoclopramide HCl

Mitomycin

Ondansetron HCl

Paclitaxel

Piperacillin sodium–tazobactam sodium

Sargramostim

Teniposide

Thiotepa

Vinblastine sulfate

Vincristine sulfate

Vinorelbine tartrate

Actions

  • Antineoplastic antibiotic; active against gram-positive and gram-negative bacteria and fungi, but its cytotoxicity precludes its use as an anti-infective agent.b

  • Precise mechanism(s) of action not fully known but may involve inhibition of DNA synthesis and to a lesser extent inhibition of RNA and protein synthesis.121

    Inhibits incorporation of thymidine into DNA.b

  • Exhibits no immunosuppressive activity.b

Advice to Patients

  • Advise patients about risk of pulmonary toxicity and to report any changes in pulmonary function (e.g., wheezing) to their clinician.b 121

  • Advise lymphoma patients of risk of severe idiosyncratic reactions (hypotension, mental confusion, fever, chills, wheezing).121

  • Advise patients to report any sudden onset of chest pain to their clinician.b 121

  • Advise patients of dermatologic and mucocutaneous effects and that they may not be apparent for several weeks after 100–200 units have been given.b 121

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.121

  • Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.121

  • Importance of informing patients of other important precautionary information.121 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Bleomycin Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection

15 units (of bleomycin)*

Blenoxane

Bristol-Myers Squibb

Bleomycin Sulfate for Injection

Bedford, Mayne, Sicor

30 units (of bleomycin)*

Blenoxane

Bristol-Myers Squibb

Bleomycin Sulfate for Injection

Bedford, Mayne, Sicor

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

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