Dosing and uses of Bleomycin (Blenoxane)
Adult dosage forms and strengths
powder for injection
- 15unit
- 30unit
Squamous Cell Carcinoma
0.25-0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC q1-2Weeks
Hodgkin's Disease, Non-Hodgkin's Lymphoma
Administer test dose of 1-2 units of bleomycin before first 1-2 doses; monitor vital signs q15min; wait 1 hour minimum before administering remainder of dose; if no acute reaction observe, may administer regular dosage schedule
0.25 to 0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC q1-2Weeks; reduce to maintenance dose of 1 unit qDay or 5 unit qWeek IV/IM after 50% response
Testicular Carcinoma
0.25-0.5 unit/kg (10 to 20 unit/m²) IV/IM/SC q1-2Weeks
Pleural Sclerosing
60 unit in 50-100 mL as single instillation; may repeat dose at intervals of several days if fluid continues to accumulate (mix in 50-100 mL or NS); may add lidocaine 100-200 mg to reduce local discomfort
Elderly: May limit dose to 40 unit/m²
Pancreatic Cancer (Orphan)
Treatment of pancreatic cancer
Orphan indication sponsors
- Genetronics, Inc; 11199 Sorrento Valley Rd; San Diego, CA 92121-1334
- CIRJ Company Ltd; 1800 Loma Vista St; Pasadena, CA 91004
Renal Impairment
CrCl >50 mL/min: Dose adjustment not necessary
CrCl 40-50 mL/min: 70% of normal dose
CrCl 30-40 mL/min: 60% of normal dose
CrCl 20-30 mL/min: 55% normal dose
CrCl 10-20 mL/min: 45% normal dose
CrCl 5-10 mL/min: 40% normal dose
Hepatic Impairment
Dose adjustment not necessary
Monitor
Chest X-ray q1-2Weeks
Administration
In lymphoma patients, give first 2 doses at 1-2 units to test for anaphylactoid reaction
Limit lifetime dose to <400 units because of risk of pulmonary fibrosis
Low ADRs w/intrapleural administration
Pediatric dosage forms and strengths
Not recommended
Bleomycin (Blenoxane) adverse (side) effects
>10%
Mucocutaneous toxicity including rash, erythema, hyperpigmentation, urticaria (>50%)
Febrile reactions, acute (25-50%)
Mucositis (30%)
Stomatitis (30%)
Interstitial pneumonitis (10%)
Pulmonary fibrosis (10%)
Anorexia
Weight loss
Rales
Tachypnea
1-10%
Alopecia (1-10%)
Fatal pulmonary fibrosis (1%)
Confusion
Shivering
Anphylactoid rxns
Onycholysis
Pruritus
Skin thickening
Skleroderma
<1%
Nausea
Malaise
Myocardial infarction
Hypotension
Cerebral vascular accident
Raynaud's phenomenon
Fatal pulmonary fibrosis
Hepatotoxicity
Renal toxicity
Necrolysis
Hyperpigmentation
Warnings
Black box warnings
Severe idiosyncratic reactions including hypotension, confusion, fever, chills, and wheezing occurring usually after the first or second dose have been reported.
Monitoring is very important after administering these doses.
Pneumonitis that progresses to pulmonary fibrosis is the most severe toxicity reported. Risk increases in elderly persons and with doses >400 units.
The drug should be administered under the supervision of an experienced cancer chemotherapy physician.
Contraindications
Hypersensitivity
Concomitant use of bleomycin with brentuximab because of pulmonary toxicity
Cautions
Use cautioin in renal impairment
Hepatic toxicity reported
Use caution when administering oxygen during surgery (increases risk of pulmonary toxicity)
Risk of pulmonary fibrosis (at lower doses if used with other antineoplastics)
Avoid pregnancy
Pregnancy and lactation
Pregnancy category: d
Lactation: It is not known whether the drug is excreted in milk. Because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued by women receiving bleomycin therapy.
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Bleomycin (Blenoxane)
Mechanism of action
Glycopeptide antibiotic; inhibits DNA, RNA, protein synthesis in G2, M phases
Pharmacokinetics
Half-Life: 2 hr
Protein Bound: 1%
Vd: 17 L/m²
Metabolism: Unknown
Metabolites: Bleomycin-iron complex
Clearance: 35 mL/min
Excretion: Urine (50-70%)
Administration
IV Incompatibilities
Solution: D5W
Additive: aminophylline, ascorbic acid injection, cefazolin, diazepam, hydrocortisone sodium succinate, methotrexate, mitomycin, nafcillin, penicillin G sodium, terbutaline
IV Compatibilities
Solution: Ns
Additive (partial list): diphenhydramine, fluorouracil, heparin, hydrocortisone Na-phosphate
Syringe (partial list): cisplatin, furosemide, heparin, methotrexate, metoclopramide, mitomycin
Y-site (partial list): allopurinol, cisplatin, etoposide PO4, gemcitabine, heparin, metoclopramide, mitomycin, ondansetron, paclitaxeL
IV/IM Preparation
IV: reconstitute 15 U vial in 5 mL & 30 U vial in 10 mL NS to yield 3 U/mL solution
IM/SC: reconstitute 15 U vial in 1-5 mL & 30 U vial in 2-10 mL NS/SWI/BWI
Do not use dextrose-containing diluents
Although may be stable for longer periods, preferably use within 24 hr of reconstitution
IV/IM Administration
IM/SC: may cause pain at injection site
IV: may be irritant; administer by slow inj over 10 min; pH: 4.5-6.0
Storage
Refrigerate intact vials of powder; stable under refrigeration (2-8°C)
