AHFS Class:

10:00 Antineoplastic Agents

Generic Name

• Bleomycin Sulfate

Bleomycin sulfate is available in vials containing 15 and 30 units of bleomycin as the sulfate.²⁹³⁶; ²⁹³⁷ Sulfuric acid or sodium hydroxide may have been added to some products to adjust the pH.²⁹³⁷

For intramuscular or subcutaneous administration, reconstitute the 15-unit vial with 1 to 5 mL and the 30-unit vial with 2 to 10 mL of sterile water for injection, sodium chloride 0.9%, or bacteriostatic water for injection.²⁹³⁶; ²⁹³⁷ For intravenous injection, reconstitute the 15-unit or 30-unit vial with 5 or 10 mL, respectively, of sodium chloride 0.9%.²⁹³⁶; ²⁹³⁷ For intrapleural administration, dissolve 60 units in 50 to 100 mL of sodium chloride 0.9%.²⁹³⁶; ²⁹³⁷ The manufacturers state that dextrose-containing diluents should not be used for the reconstitution or dilution of bleomycin sulfate; analysis has revealed a loss in drug potency that occurs with the use of dextrose 5% that does not occur with the use of sodium chloride 0.9%.²⁹³⁶; ²⁹³⁷

Units

Bleomycin sulfate is a mixture of cytotoxic glycopeptide antibiotics.²⁹³⁶; ²⁹³⁷ In the United States, a unit of bleomycin is equal to the term milligram activity, which was formerly used.²⁹³⁶; ²⁹³⁷ One unit of bleomycin is equivalent in activity to 1 mg of bleomycin A₂ reference standard.⁴

Bleomycin sulfate may be administered by intramuscular, subcutaneous, or intravenous injection, or by intrapleural instillation through a thoracostomy tube.²⁹³⁶; ²⁹³⁷ Intravenous injections should be given slowly over a 10-minute period.²⁹³⁶; ²⁹³⁷

Intact vials are stable under refrigeration.²⁹³⁶; ²⁹³⁷ They also have been stated to be stable for 28 days at room temperature.¹¹⁸¹; ¹⁴³³

The manufacturers state that bleomycin in sodium chloride is stable for 24 hours at room temperature.²⁹³⁶; ²⁹³⁷ Bleomycin sulfate solutions reconstituted with sodium chloride 0.9% also have been reported to be stable for 4 weeks when stored at 2 to 8°C,⁴; ¹³⁶⁹ for 2 weeks⁴ to 4 weeks (protected from light)¹³⁶⁹ at room temperature, and for 10 days at 37°C.¹⁰⁷³

Ogawa et al. reported that immersion of a needle with an aluminum component in bleomycin sulfate (Bristol) 3 units/mL resulted in no visually apparent reaction after 7 days at 24°C.⁹⁸⁸

In the event of spills or leaks, the use of sodium hypochlorite 5% (household bleach) or potassium permanganate 1% has been recommended to inactivate bleomycin sulfate.¹²⁰⁰

pH Effects

Bleomycin sulfate (Bristol) is stable in solution over a pH range of 4 to 10.⁷⁶³

Filtration

Bleomycin sulfate was shown not to exhibit substantial sorption to cellulose ester (Ivex-2), cellulose nitrate/cellulose acetate (Millex OR), nylon, or Teflon (Millex FG) filters.⁵³³; ¹⁴¹⁵; ¹⁴¹⁶; ¹⁵⁷⁷

Solution Compatibility

Additive Compatibility

Drugs in Syringe Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions March 31, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.