Aldesleukin is available as a lyophilized powder in single-dose vials containing 22 million international units (1.3 mg).3236 Reconstitute each vial with 1.2 mL of sterile water for injection, directing the stream of diluent toward the vial wall and not directly on the lyophilized powder.3236 Slowly swirl the vial; do not shake.3236 Do not reconstitute with bacteriostatic water for injection or sodium chloride 0.9%.3236 Each mL of the reconstituted solution contains aldesleukin 18 million international units (1.1 mg), mannitol 50 mg, and sodium dodecyl sulfate 0.19 mg, along with disodium hydrogen phosphate dihydrate 1.12 mg and sodium dihydrogen phosphate dihydrate 0.19 mg as buffering agents.3236
The reconstituted solution should be further diluted in dextrose 5% in PVC bags to yield a final concentration between 0.03 and 0.07 mg/mL based on the required dose as follows:3236
| Dose | Volume of Dextrose 5% |
|---|---|
| =25.4 million international units (=1.5 mg) | 25 mL |
| >25.4 million to 60 million international units (>1.5 to 3.5 mg) | 50 mL |
| >60 million international units (>3.5 mg) | 100 mL |
Units
Aldesleukin 18 million international units is equivalent to 1.1 mg.3236
pH
The product is buffered to a pH of 7.5 (7.2 to 7.8).3236
Trade Name(s)
Proleukin
Aldesleukin is administered by intravenous infusion over 15 minutes.3236 Do not use inline filters.3236 Refrigerated solutions should be allowed to come to room temperature prior to administration.3236
Aldesleukin is a white to off-white lyophilized powder that forms a clear, colorless to slightly yellow liquid when reconstituted.3236 Intact vials should be stored at 2 to 8°C in the original carton to protect from light.3236
Diluted solutions for infusion may be stored at 2 to 8°C, protected from light, for no more than 48 hours from the time of preparation to the end of the infusion.3236 Do not freeze.3236 Refrigerated solutions should be allowed to come to room temperature prior to administration.3236
Syringes
Aldesleukin (Cetus), reconstituted according to label directions, was evaluated for stability when stored in 1-mL plastic syringes (Becton Dickinson). One- and 0.5-mL aliquots were drawn into these syringes and refrigerated for 5 days. The product was physically stable and retained activity by biological analysis (cell proliferation assay) throughout the study period.1821
Reconstituted aldesleukin diluted to a concentration of 220 mcg/mL with dextrose 5% was repackaged aseptically as 1 mL drawn into tuberculin syringes and stored under refrigeration at 2 to 8°C. The drug was found to be stable for the 14-day study period.1890
Ambulatory Pumps
For continuous intravenous infusion of aldesleukin in concentrations of 70 mcg/mL or less via an ambulatory pump at the accompanying higher temperature of near 32°C, the dose should be diluted in dextrose 5% to which albumin human at a concentration of 0.1% has been added to maintain aldesleukin stability.1890 In the absence of albumin human, visually observed precipitation and loss of aldesleukin activity has been found. At concentrations greater than 70 and less than 100 mcg/mL at 32°C, aldesleukin is unstable whether albumin human is present or not.1890
Aldesleukin (Cetus) 5 to 500 mcg/mL in dextrose 5% was evaluated for stability in polyvinyl chloride (PVC) containers during simulated administration from pumps (CADD-1, Pharmacia Deltec). At 100 to 500 mcg/mL, aldesleukin was stable for 6 days at 32°C and remained visually clear throughout the study period. At concentrations of 5 and 40 mcg/mL, however, albumin human 0.1% was necessary to maintain physical stability. The aldesleukin solutions with albumin human remained clear and remained active for 6 days at 32°C. Without albumin human, precipitation occurred within a few hours.1821
Filtration
Do not use inline filters when administering aldesleukin.3236
For a list of references cited in the text of this monograph, search the monograph titled References.