Sargramostim is available as a lyophilized powder in single-dose vials labeled as containing 250 mcg.116 Reconstitute the vial with 1 mL of sterile water for injection or bacteriostatic water for injection containing benzyl alcohol 0.9%.116 Each mL of the reconstituted solution contains sargramostim 250 mcg, mannitol 40 mg, sucrose 10 mg, and tromethamine 1.2 mg.116 The contents of vials reconstituted with different diluents should not be mixed.116
For use in neonates or low birth weight infants, only sterile water for injection should be used to reconstitute sargramostim.116
pH
The reconstituted solution has a pH of 7.1 to 7.7.116
Trade Name(s)
Leukine
Sargramostim may be administered by subcutaneous injection undiluted or by intravenous infusion usually over 2 to 4 hours after dilution in sodium chloride 0.9%.116 For diluted sargramostim concentrations below 10 mcg/mL, albumin human at a final concentration of 0.1% should be added to the intravenous solution to prevent adsorption.116
Sargramostim reconstituted with bacteriostatic water for injection containing benzyl alcohol should not be used in neonates or low birth weight infants.116
Intact vials of sargramostim should be stored at 2 to 8°C in the original carton to protect from light.116 Vials should be protected from freezing and should not be shaken.116
Sargramostim is a white lyophilized powder that forms a clear, colorless solution upon reconstitution.116 Reconstituted solutions should be stored at 2 to 8°C and not frozen.116 When reconstituted with sterile water for injection, the solution must be used within 24 hours of reconstitution.116 When reconstituted with bacteriostatic water for injection preserved with benzyl alcohol 0.9%, the solution must be used within 20 days of reconstitution.116
Other information indicates that sargramostim reconstituted with sterile water for injection or bacteriostatic water for injection is stable for 30 days at 25°C or under refrigeration.226
Solutions diluted in sodium chloride 0.9% for infusion should be used immediately.116
Syringes
Sargramostim 250 mcg and 500 mcg reconstituted with 1 mL of bacteriostatic water for injection with benzyl alcohol 0.9% and repackaged in 1-mL tuberculin syringes (Becton Dickinson) is stated to be stable for 14 days when stored under refrigeration.226
Sorption
Sargramostim may adsorb to drug delivery systems (i.e., containers and tubing) at concentrations below 10 mcg/mL.116 If the sargramostim concentration is less than 10 mcg/mL, albumin human should be added to the infusion solution a final albumin concentration of 0.1% to prevent sargramostim adsorption.116
Filtration
Sargramostim should not be infused through an inline filter.116
For a list of references cited in the text of this monograph, search the monograph titled References.