bleomycin sulfate
bleomycin sulfate
Pharmacologic class: Antitumor antibiotic
Therapeutic class: Antineoplastic
Pregnancy risk category D
FDA Box 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.
See Know that cumulative dosages above 400 units should be given with extreme caution because of increased risk of pulmonary toxicity.
See Know that in patients with lymphoma, anaphylactoid reaction may occur. Such patients should receive 2 units or less for the first two doses. If no reaction occurs, recommended doses may be given.
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 not to receive vaccinations without consulting prescriber.
See Instruct patient to immediately notify prescriber if breathing difficulties, fever, or chills occur.
• 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.