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Uses

Hodgkin’s Disease

Treatment of Hodgkin’s disease.

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

Various combination regimens are used.

Commonly used in combination with doxorubicin, vinblastine, and dacarbazine (ABVD regimen).

Non-Hodgkin’s Disease

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

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.

Testicular Cancer

Treatment of testicular embryonal cell carcinoma, choriocarcinoma, and teratocarcinoma.

Combination chemotherapy with bleomycin, cisplatin, and etoposide is a regimen of choice for the treatment of advanced nonseminomatous testicular carcinoma.

Combination chemotherapy with bleomycin, cisplatin, and etoposide is used for the treatment of disseminated seminoma testis.

Pleural Effusions

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

At least as effective and possibly better tolerated than intrapleural tetracycline.

Intrapleural talc may be preferred because of cost considerations.

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

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).

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

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

Cervical Cancer

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

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

Penile or Vulval Cancer

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

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).

Has been used as monotherapy for palliative treatment of early-stage disease.

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

Ovarian Cancer

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

Intracranial Germ Cell Tumors

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

Dosage and Administration

General

• Individualize dosage carefully according to individual requirements and response.
• Consult specialized references for procedures for proper handling and disposal of antineoplastics.

Sensitivity Testing

• Risk of anaphylactoid reactions in lymphoma patients (e.g., those with Hodgkin’s and non-Hodgkin’s disease).
• Administer 2 test doses (i.e., ≤2 units of bleomycin) before initiating full-dose therapy.
• After each test dose, monitor carefully for severe idiosyncratic reactions (see Boxed Warning). If no acute reaction occurs, recommended dosage regimen may then be administered.
• Take precautions to treat potential allergic reactions.

Premedication

• Intrapleural injection of local anesthetics or systemic administration of opiates prior to the intrapleural procedure may relieve pain associated with pleurodesis but generally are not considered necessary.

Administration

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

IV Administration

Administer by IV injection once or twice weekly.

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.

Rate of Administration

Administer IV slowly over a 10-minute period.

IM Administration

Administer by IM injection once or twice weekly.

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.

Sub-Q Administration

Administer by sub-Q injection once or twice weekly.

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.

Intrapleural Administration

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

Drain pleural fluid via the thoracostomy by gravity or suction prior to instillation; confirmation of complete expansion of the lungs is recommended.

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

Reconstitution

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

Dosage

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

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

Adults

Hodgkin’s Disease

Increased sensitivity risk in lymphomas; administer test doses. (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.

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

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

Non-Hodgkin’s Lymphoma

Increased sensitivity risk in lymphomas; administer test doses. (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.

Testicular Cancer

IV, IM, or Sub-Q

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

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

Squamous Cell Carcinomas

IV, IM, or Sub-Q

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

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

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) of the patient during the next 4 hours, and subsequent removal of the fluid.

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; allowing the chest tube to remain for at least 4 days after instillation may prevent pneumothorax.

Dosage Modification for Toxicity

Prescribing Limits

Adults

IV, IM, or Sub-Q

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

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

Intrapleural

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

Special Populations

Dosage in Renal Impairment

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