DOSAGE AND ADMINISTRATION
Because of the possibility of an anaphylactoid reaction, lymphoma patients
should be treated with 2 units or less for the first 2 doses. If no acute reaction
occurs, then the regular dosage schedule may be followed.
The following dose schedule is recommended:
Squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma - 0.25
to 0.50 units/kg (10 to 20 units/m²) given intravenously, intramuscularly,
or subcutaneously weekly or twice weekly.
Hodgkin's disease - 0.25 to 0.50 units/kg (10 to 20 units/m²) given
intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After
a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously
or intramuscularly should be given.
Pulmonary toxicity of BLENOXANE (bleomycin sulfate injection) appears to be dose-related with a striking
increase when the total dose is over 400 units. Total doses over 400 units should
be given with great caution.
Note: When BLENOXANE (bleomycin sulfate injection) is used in combination with other antineoplastic agents,
pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin's disease and testicular tumors is prompt and noted
within 2 weeks. If no improvement is seen by this time, improvement is unlikely.
Squamous cell cancers respond more slowly, sometimes requiring as long as 3
weeks before any improvement is noted.
Malignant Pleural Effusion - 60 units administered as a single dose bolus
intrapleural injection (see Administration: Intrapleural).
Use in Patients with Renal Insufficiency
The following dosing reductions are proposed for patients with creatinine clearance
(CrCL) values of less than 50 mL/min:
|Patient CrCL (mL/min)
||BLENOXANE Dose (%)
|50 and above
CrCL can be estimated from the individual patient's measured serum creatinine
(Scr) values using the Cockcroft and Gault formula:
Males CrCL = [weight Ã (140 – Age)]/(72 Ã Scr)
Females CrCL = 0.85 Ã [weight Ã (140 – Age)]/(72 Ã Scr)
Where CrCL in mL/min/1.73m², weight in kg, age in years, and Scr in mg/dL.
BLENOXANE (bleomycin sulfate injection) may be given by the intramuscular, intravenous, subcutaneous, or
Caution should be exercised when handling BLENOXANE (bleomycin sulfate injection) for injection. Procedures
for proper handling and disposal of anticancer drugs should be utilized. Several
guidelines on this subject have been published.1-4 To minimize the
risk of dermal exposure, always wear impervious gloves when handling vials containing
BLENOXANE (bleomycin sulfate injection) for injection. If BLENOXANE (bleomycin sulfate injection) for injection contacts the skin, immediately
wash the skin thoroughly with soap and water. If contact with mucous membranes
occurs, the membranes should be flushed immediately and thoroughly with water.
More information is available in the references listed below.
Intramuscular or Subcutaneous
The BLENOXANE (bleomycin sulfate injection) 15 units vial should be reconstituted with 1 to 5 mL of Sterile
Water for Injection, USP, Sodium Chloride for Injection, 0.9%, USP, or Sterile Bacteriostatic Water for Injection, USP. The BLENOXANE (bleomycin sulfate injection) 30 units vial should
be reconstituted with 2 to 10 mL of the above diluents.
The contents of the 15 units or 30 units vial should be dissolved in 5 mL or
10 mL, respectively, of Sodium Chloride for Injection, 0.9%, USP, and administered
slowly over a period of 10 minutes.
Sixty units of BLENOXANE (bleomycin sulfate injection) are dissolved in 50 to 100 mL Sodium Chloride for
Injection, 0.9%, USP, and administered through a thoracostomy tube following
drainage of excess pleural fluid and confirmation of complete lung expansion.
The literature suggests that successful pleurodesis is, in part, dependent upon
complete drainage of the pleural fluid and reestablishment of negative intrapleural
pressure prior to instillation of a sclerosing agent. Therefore, the amount
of drainage from the chest tube should be as minimal as possible prior to instillation
of BLENOXANE (bleomycin sulfate injection) . Although there is no conclusive evidence to support this contention,
it is generally accepted that chest tube drainage should be less than 100 mL
in a 24-hour period prior to sclerosis. However, BLENOXANE (bleomycin sulfate injection) instillation may
be appropriate when drainage is between 100 to 300 mL under clinical conditions
that necessitate sclerosis therapy. The thoracostomy tube is clamped after BLENOXANE (bleomycin sulfate injection)
instillation. The patient is moved from the supine to the left and right lateral
positions several times during the next four hours. The clamp is then removed
and suction reestablished. The amount of time the chest tube remains in place
following sclerosis is dictated by the clinical situation.
The intrapleural injection of topical anesthetics or systemic narcotic analgesia
is generally not required.
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container permit.
BLENOXANE® (bleomycin sulfate for injection, USP) is available as follows:
NDC 0015-3010-20, 15 units per vial as bleomycin sulfate
for injection, USP.
NDC 0015-3063-01, 30 units per vial as bleomycin sulfate
for injection, USP.
The sterile powder is stable under refrigeration 2°C (36°F) to 8°C
(46°F) and should not be used after the expiration date is reached.
BLENOXANE (bleomycin sulfate injection) should not be reconstituted or diluted with D5W or other dextrose
containing diluents. When reconstituted in D5W and analyzed by HPLC, BLENOXANE (bleomycin sulfate injection)
demonstrates a loss of A2 and B2 potency that does not occur when BLENOXANE (bleomycin sulfate injection)
is reconstituted in Sodium Chloride for Injection, 0.9%, USP.
BLENOXANE (bleomycin sulfate injection) is stable for 24 hours at room temperature in Sodium Chloride.
1. NIOSH Alert: Preventing occupational exposures to antineoplastic
and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health
and Human Services, Public Health Service, Centers for Disease Control and Prevention,
National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication
No. 2004 165.
2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2.
Controlling occupational exposure to hazardous drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
3. American Society of Health-System Pharmacists. ASHP guidelines
on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy
and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh,
PA: Oncology Nursing Society.
Manufactured by: Nippon Kayaku Co., Ltd. Tokyo, Japan. Distributed by: Bristol-Myers
Squibb Company Princeton, NJ 08543 USA. Rev April 2010