NAME OF DRUG
bleomycin

CLASSIFICATION

Cytotoxic agent - non-vesicant

ALTERNATE NAMES

BLENOXANE

INDICATIONS

• treatment of certain carcinomas (head and neck, skin, kidneys), testicular carinoma, soft tissue and other sarcomas

PHARMACOLOGY

• bleomycin appears to inhibit the incorporation of thymidine into DNA and to labilize the DNA structure, resulting in scission of both single and double-stranded DNA
• in patients with normal renal function, the serum half-life of bleomycin is about 2 hours
• the drug is 60-70% excreted in the urine as active drug

RECONSTITUTION AND STABILITY

• ALL cytotoxic agents are prepared in pharmacy and will be sent to the ward with a label indicating storage conditions and the expiry date.  All cytotoxic waste including bags, sets, tubing, gloves, etc. must be properly disposed of in the cytotoxic waste containers on the nursing unit.
• ALL solutions prepared by Pharmacy must be refrigerated

COMPATIBILITY

• compatible with sterile water for injection, D5W, D10W, NS
• compatible with dexamethasone, diphenhydramine, heparin
• incompatible with aminophylline, ascorbic acid, furosemide, hydrocortisone, hyoscine

ROUTES OF ADMINISTRATION

• SC
• IM
• IV direct or intra-arterial - give slowly over 10 minutes
• IV intermittent - infuse over 10-15 minutes
• IV infusion - infuse over a 24 hour period
• intrapleural injection
• NOTE:  Continuous IV infusion may lessen pulmonary toxicity and maximize cell kill

VH & HSC ADMINISTRATION POLICY

Intrapleural and intra-arterial injections by physician only.

The first SC, IM or IV dose may be given only when the physician is in attendance on the ward.

A Parenteral Chemotherapy/Immunotherapy pre-printed order form (PPO # 45) must be used for prescribing if this cytotoxic agent
is not already on an existing PPO.

G - Cytotoxic Agents - see Drug Table G for specific administration guidelines.
H - The IV infusion administration rate be controlled by an automated infusion control device.

Epinephrine (1:1000) and hydrocortisone must be readily available in case of anaphylaxis (more frequent in lymphoma patients).

DOSAGE

Dose and schedule depend on the protocol and patient response.

• Usual parenteral dose: 10-20 units/m²
• Maximum cumulative dose: 400 units
• Dose reduction is recommended in renal impairment: if GFR <10 mL/minute, reduce dose by 50%
• 1 mg is approximately equivalent to 1 unit

POTENTIAL HAZARDS OF PARENTERAL ADMINISTRATION

• anaphylaxis - rarely (mainly in lymphoma patients); usually occurs after the first or second dose and may be immediate or delayed for several hours (See Appendix VIII)
• febrile reactions - occur within a few hours after large single doses and last for 4-12 hours; they become less frequent with continued use of the drug
• pain and thrombophlebitis at the injection site
• extravasation - non vesicant (see appendix VII)

IMPORTANT IMPLICATIONS

• pulmonary toxicity is a major and delayed toxicity that appears to be dose and age-related (especially over 70 years); it usually does not occur if the cumulative dose is below 150 units/m², the incidence increases to 55% if total dose is 283 units/m², and 66% if 360 units/m²
• oxygen or radiation therapy in patients who have taken bleomycin is associated with a higher incidence of lung toxicity
• pulmonary status should be monitored with pulmonary function tests and X-rays
• mucocutaneous toxicity (eg stomatitis) is the most frequent adverse effect (50%) and is usually evident within 1-3 weeks following the initiation of therapy and after a cumulative dose of 150-200 units
• other reactions include: urticaria, erythematous swelling, hyperpigmentation, diffuse alopecia
• anorexia and weight loss are common and may persist after the discontinuance of bleomycin
• NOTE:  bleomycin is not myelosuppressive

VGH Site only:
Notify security -84 immediately upon accidental spillage.
DO NOT ATTEMPT CLEAN-UP

• See also Appendix VI

Rev. May 2006