Classifications: antineoplastic; antibiotic; Therapeutic: antineoplastic agent
Pregnancy Category: D
15 units, 30 units powder for injection
A toxic drug with low therapeutic index; intensely cytotoxic. By unclear mechanism, blocks DNA, RNA, and protein synthesis.
A cell cycle-phase nonspecific agent. Widely used in combination with other chemotherapeutic agents because it lacks significant
This mixture of cytotoxic antibiotics from a strain of Streptomyces verticillus has strong affinity for skin and lung tumor cells, in contrast to its low affinity for cells in hematopoietic tissue.
As single agent or in combination with other chemotherapeutic agents, as adjunct to surgery and radiation therapy. Squamous
cell carcinomas of head, neck, penis, cervix, and vulva; lymphomas (including reticular cell sarcoma, lymphosarcoma, Hodgkin's);
testicular carcinoma; malignant pleural effusions.
Mycosis fungoides and Verruca vulgaris (common warts), AIDS related Kaposi's sarcoma.
History of hypersensitivity or idiosyncrasy to bleomycin; pulmonary infection; concurrent radiation therapy; women of childbearing
age, pregnancy (category D), lactation.
Compromised hepatic, renal, or pulmonary function; peripheral vascular disease; history of tobacco use; previous cytotoxic
drug or radiation therapy.
Route & Dosage
|Squamous Cell Carcinoma, Testicular Carcinoma
Adult/Child: SC, IM, IV 1020 U/m2 or 0.250.5 U/kg 12 times/wk (max: 300400 U)
Adult/Child: SC, IM, IV 1020 U/m2 12 times/wk after a 12 U test dose times 2 doses
Hodgkin's Disease, Maintenance
Adult/Child: SC, IM, IV 1 U IM or IV/d or 5 U/wk
Clcr 1050 mL/min: use 75% of dose; <10 mL/min: use 50% of dose
Note: Due to risk of anaphylactoid reaction, give lymphoma patients ≤2 U for first
two doses. If no reaction, follow regular dosage schedule.
- Reconstitute with sterile water, NS, or bacteriostatic water by adding 15 mL to the 15 U vial or 210 mL to the
30 U vial. Amount of diluent is determined by the total volume of solution that will be injected.
- Inject IM deeply into upper outer quadrant of buttock; change sites with each injection.
IV administration to infants and children: Verify correct IV concentration and rate of infusion with physician.
PREPARE: Intermittent: ??Dilute each 15 U with at least 5 mL of sterile water or NS.??May be further diluted in 50100 mL of the chosen diluent.??Do not dilute with any solution containing D5W.
ADMINISTER: Intermittent: Give each 15 U or fraction thereof over 10 min through Y-tube of free-flowing IV.
INCOMPATIBILITIES Solution/additive: Aminophylline, ascorbic acid, carbenicillin, cephalosporins, diazepam, hydrocortisone, methotrexate, mitomycin, nafcillin, penicillin G, terbutaline.
- Store unopened ampules at 15°30° C (59°86° F) unless otherwise specified by manufacturer.
Adverse Effects (≥1%)Body as a Whole:
Hypersensitivity (anaphylactoid reaction
); mild febrile reaction
Headache, mental confusion. GI:
Stomatitis, ulcerations of tongue and lips, anorexia, nausea, vomiting, diarrhea, weight loss. Hematologic:
Thrombocytopenia, leukopenia, (rare). Respiratory: Pulmonary toxicity
(dose and age-related); interstitial pneumonitis, pneumonia
, or fibrosis. Skin:
Diffuse alopecia (reversible), hyperpigmentation, pruritic erythema,
, thickening of skin and nail beds, patchy hyperkeratosis,
striae, peeling, bleeding. Other:
Pain at tumor site; phlebitis; necrosis at injection site, shivering.
Other antineoplastic agents
increase bone marrow toxicity; decreases effects of digoxin, phenytoin,
avoid use with LIVE VACCINES
Concentrates mainly in skin, lungs, kidneys, lymphocytes, and peritoneum. Metabolism:
6070% recovered in urine as parent compound. Half-Life:
Assessment & Drug Effects
- Start with a test dose. Monitor patient closely for at least 24 h (vital signs, auscultation of chest, careful observations).
If there is no acute reaction (hypotension, hyperpyrexia, chills, confusion, wheezing, cardiopulmonary collapse), start
regular dosage schedule. Anaphylactoid reaction can be fatal (see Appendix F). It may occur immediately or several hours
after first or second dose, especially in lymphoma patients (10%).
- Therapeutic effectiveness: Favorable response, if any, is expected within 2 wk for treatment of Hodgkin's or testicular tumor,
and within 3 wk for squamous cell cancers.
- Monitor vital signs. Febrile reaction (mild chills and fever) is relatively common in patients receiving bleomycin therapy.
It usually occurs within the first few hours after administration of a large single dose and lasts about 412 h. Reaction
tends to become less frequent with continued drug administration, but can recur at any time.
- Monitor for and report any of the following: Unexplained bleeding or bruising; evidence of deterioration of renal function
(changed I&O ratio and pattern, decreasing creatinine clearance, weight gain or edema); evidence of pulmonary toxicity (nonproductive
cough, chest pain, dyspnea).
- Note: Stomatitis can be a dose-limiting factor because oral ulcerations may interfere with adequate nutrient intake, leading to
severe debilitation. Consult physician if an oral local anesthetic is indicated. Apply 10 min before meals to take effect
so that patient can eat with less pain.
- Check weight at regular intervals under standard conditions. Weight loss and anorexia may persist a long time after therapy
has been discontinued.
- Report symptoms of skin toxicity (hypoesthesia, urticaria, tender swollen hands) promptly. May develop in second or third
week of treatment and after 150200 U of bleomycin have been administered. Therapy may be discontinued.
Patient & Family Education
- Avoid OTC drugs during antineoplastic treatment period unless approved by physician.
- Report skin irritation which may not develop for several weeks after therapy begins.
- Hyperpigmentation may occur in areas subject to friction and pressure, skin folds, nail cuticles, scars, and intramuscular