DOSAGE AND ADMINISTRATION
Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first two 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 bleomycin 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 Bleomycin for 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.
Administration
Bleomycin for Injection may be given by the intramuscular, intravenous or subcutaneous routes.
Intramuscular or Subcutaneous
The Bleomycin for Injection, USP 15 units vial should be reconstituted and dissolved with 1 to 5 mL of Sterile Water for Injection, Sodium Chloride for Injection, 0.9%, USP, or Bacteriostatic Water for Injection, USP. The Bleomycin for Injection, USP 30 units vial should be reconstituted with 2 to 10 mL of the above diluents.
Intravenous
The contents of the 15 units or 30 units vial should be dissolved in 5 mL or more or 10 mL or more, respectively of Sodium Chloride for Injection, 0.9%, USP and administered slowly over a period of 10 minutes.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Stability
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.
Bleomycin for Injection should not be reconstituted or diluted with 5% Dextrose Injection or other dextrose containing diluents. When reconstituted in 5% Dextrose Injection and analyzed by HPLC, Bleomycin for Injection demonstrates a loss of A2 and B2 potency that does not occur when Bleomycin for Injection is reconstituted in 0.9% sodium chloride.
Bleomycin for Injection, USP is stable for 24 hours at room temperature in Sodium Chloride Injection.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
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