bleomycin sulfate

bleomycin sulfate

[blē·əmī′sin]

an antineoplastic antibiotic.

indications It is prescribed in the treatment of a variety of neoplasms.

contraindication Hypersensitivity to this drug prohibits its use.

adverse effects Among the most serious adverse reactions are pneumonitis, pulmonary fibrosis, and a syndrome of hyperpyrexia and circulatory collapse. Rashes and skin reactions commonly occur.

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bleomycin sulfate Warning - Hazardous drug!

Blenoxane

Pharmacologic class: Antitumor antibiotic

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA Boxed Warning

• Give under supervision of physician in facility with adequate diagnostic and treatment resources.
• Pulmonary fibrosis is most severe toxicity, and most often presents as pneumonitis progressing to pulmonary fibrosis. Occurrence is highest in elderly patients and those receiving more than 400 units total dose.

Action

Unclear. Appears to inhibit DNA synthesis and, to a lesser degree, RNA and protein synthesis. Binds to DNA, causing severing of single DNA strands.

Availability

Injection: 15-unit vials, 30-unit vials

⊘Indications and dosages

➣ Hodgkin's lymphoma

Adults: 10 to 20 units/m² I.V., I.M., or subcutaneously once or twice weekly. After 50% response, maintenance dosage is 1 unit/m² I.M. or I.V. daily or 5 units/m² I.M. or I.V. weekly.

➣ Malignant pleural effusion; prevention of recurrent pleural effusions

Adults: 60 units dissolved in 50 to 100 mg of normal saline solution, given through thoracostomy tube

➣ Squamous cell carcinoma of head, neck, skin, penis, cervix, or vulva; non-Hodgkin's lymphoma; testicular carcinoma

Adults and children ages 12 and older: 10 to 20 units/m² I.V., I.M., or subcutaneously once or twice weekly.

Dosage adjustment

• Renal impairment
• Elderly patients

Off-label uses

• Esophageal carcinoma
• Hemangioma
• AIDS-related Kaposi's sarcoma
• Osteosarcoma
• Verrucous carcinoma
• Warts

Contraindications

• Hypersensitivity to drug
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• renal or pulmonary impairment
• elderly patients
• females of childbearing age.

Administration

• Wash hands before and after preparing drug; wear gloves during handling and preparation.
• For I.M. or subcutaneous use, reconstitute 15-unit vial with 1 to 5 ml and 30-unit vial with 2 to 10 ml of sterile water for injection, normal saline solution for injection, or bacteriostatic water for injection.
• For I.V. infusion, dissolve contents of 15- or 30-unit vial in 5 or 10 ml, respectively, of normal saline solution for injection.
• For intrapleural use, dissolve each 60 units in 50 to 100 ml of normal saline solution for injection, then administer through thoracostomy tube. Clamp tube after instilling drug. During next 4 hours, reposition patient from supine to right and left lateral positions several times. Then unclamp tube and restart suction.
• Premedicate patient with aspirin, as prescribed, to reduce risk of drug fever.
☞ Know that cumulative dosages above 400 units should be given with extreme caution because of increased risk of pulmonary toxicity.

Route	Onset	Peak	Duration
I.V.	Immediate	10-20 min	Unknown
I.M., subcut.	15-20 min	30-60 min	Unknown

Adverse reactions

CNS: disorientation, weakness, aggressive behavior

CV: hypotension, peripheral vasoconstriction

GI: vomiting, diarrhea, anorexia, stomatitis

Hematologic: anemia, leukopenia, thrombocytopenia

Hepatic: hepatotoxicity

Metabolic: hyperuricemia

Respiratory: dyspnea, crackles, pulmonary fibrosis, pneumonitis

Skin: alopecia, erythema, rash, urticaria, vesicles, striae, hyperpigmentation, mucocutaneous toxicity

Other: fever, chills, weight loss, anaphylactic reaction

Interactions

Drug-drug. Anesthestics: increased oxygen requirement

Antineoplastics: increased risk of hematologic and pulmonary toxicity

Cardiac glycosides: decreased cardiac glycoside blood level

Cisplatin: decreased bleomycin elimination, increased risk of toxicity

Fosphenytoin, phenytoin: decreased blood levels of these drugs

Vinblastine: increased risk of Raynaud's syndrome

Drug-diagnostic tests. Uric acid: increased level

Patient monitoring

• Assess baseline pulmonary function status before initiating therapy; monitor throughout therapy.
• Monitor chest X-rays and assess breath sounds to detect signs of pulmonary toxicity.
• Assess oral cavity for sores, ulcers, pain, and bleeding.
• Monitor infusion site for irritation, burning, and signs of infection.
• Evaluate closely for signs and symptoms of drug fever.

Patient teaching

• Tell patient to avoid spicy, hot, or rough foods (may cause GI upset).
• Urge patient to use reliable contraceptive method during therapy.
• Tell patient to avoid activities that can cause injury. Advise him to use soft toothbrush and electric razor to avoid gum and skin injury.
• Inform patient that drug may cause hair loss but that hair will grow back after treatment ends.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.