Decitabine (Dacogen, Otsuka; generic) is available as a lyophilized powder in single-dose vials containing 50 mg of decitabine, monobasic potassium phosphate 68 mg, sodium hydroxide 11.6 mg; sodium hydroxide and/or hydrochloric acid may have been used to adjust pH.3709; 3711 Each vial should be reconstituted with 10 mL of room temperature sterile water for injection to yield a solution containing decitabine 5 mg/mL.3709; 3711
Within 15 minutes of reconstitution,3713 the appropriate dose of the reconstituted solution should be diluted in dextrose 5% or sodium chloride 0.9% to a final decitabine concentration of 0.1 to 1 mg/mL.3709; 3711
If the dose is intended to be administered within 15 minutes of preparation, the reconstituted solution may be diluted in room temperature dextrose 5% or sodium chloride 0.9%.3709; 3711 If the dose is intended to be administered after 15 minutes of preparation, the reconstituted solution should be diluted in cold (2 to 8°C) dextrose 5% or sodium chloride 0.9%.3709; 3711
Decitabine also is available as a lyophilized powder in single-dose vials containing 50 mg of decitabine (Sun Pharma); each vial of the drug is packaged with a 10-mL vial of diluent containing monobasic potassium phosphate 68 mg, sodium hydroxide 11.6 mg, and water for injection 10 mL.3710 Each vial of decitabine should be reconstituted with 10 mL of diluent at room temperature to yield a solution containing decitabine 5 mg/mL.3710
The appropriate dose of the reconstituted solution should be diluted in dextrose 5% or sodium chloride 0.9% to a final decitabine concentration of 0.1 to 1 mg/mL.3710
If the dose is intended to be administered within 15 minutes of preparation, the reconstituted solution may be diluted in room temperature dextrose 5% or sodium chloride 0.9%.3710 If the dose is intended to be administered after 15 minutes of preparation, the reconstituted solution should be diluted in cold (2 to 8°C) dextrose 5% or sodium chloride 0.9%.3710
pH
Decitabine solution reconstituted with sterile water for injection (Dacogen, Janssen-Cilag) has a pH range of 6.7 to 7.3.3713
Trade Name(s)
Dacogen
The final diluted solution of decitabine is administered by intravenous infusion over 1 or 3 hours, depending on the dosing regimen used.3709; 3710; 3711
As with other toxic drugs, applicable special handling and disposal procedures for decitabine should be followed.3709; 3710; 3711
Decitabine (Dacogen, Otsuka; generic) is a white to off-white lyophilized powder.3709; 3711 Intact vials should be stored at controlled room temperature.3709; 3711
Decitabine packaged with diluent (Sun Pharma) is a white to off-white lyophilized powder.3710 The diluent is a clear, colorless solution.3710 Intact vials should be stored at controlled room temperature.3710
Solutions should be visually inspected for particulate matter and discoloration prior to administration; if particulate matter is present or discoloration occurs, the solution should not be used.3709; 3710; 3711
Decitabine solution reconstituted with room temperature sterile water for injection (Dacogen, Janssen-Cilag) should be diluted within 15 minutes of reconstitution.3713
The final diluted solution for infusion prepared with the formulation reconstituted with sterile water for injection (Dacogen, Otsuka; generic) or the formulation reconstituted with the provided diluent (Sun Pharma), when diluted with room temperature dextrose 5% or sodium chloride 0.9%, should be administered within 15 minutes of preparation.3709; 3710; 3711 Any unused portions should be discarded.3709; 3710; 3711
When decitabine solution reconstituted with room temperature sterile water for injection (Dacogen, Otsuka; generic) is diluted with cold (2 to 8°C) dextrose 5% or sodium chloride 0.9%, the diluted solution for infusion may be stored at 2 to 8°C for up to 4 hours from the time of preparation.3709; 3711 The refrigerated, diluted solution must be used within 4 hours from the time of preparation.3709; 3711 Any unused portions should be discarded.3709; 3711
When the decitabine solution reconstituted with the provided diluent (Sun Pharma) is diluted with cold (2 to 8°C) dextrose 5% or sodium chloride 0.9%, the diluted solution for infusion may be stored at 2 to 8°C for up to 7 hours from the time of preparation.3710 The refrigerated, diluted solution must be used within 7 hours from the time of preparation.3710 Any unused portions should be discarded.3710
Decitabine (Dacogen, Janssen-Cilag) 5 mg/mL reconstituted with cold (2 to 8°C) water for injection and stored in the original glass vials at 2 to 8°C was stable for 12 hours and exhibited less than 10% loss.3712
Decitabine (Dacogen, Janssen-Cilag) 5 mg/mL reconstituted with cold (2 to 8°C) water for injection, diluted in cold sodium chloride 0.9% in polyolefin bags to a final concentration of 0.5 mg/mL, and stored at 2 to 8°C was stable for 24 hours and exhibited less than 10% loss.3712 In another study, when reconstituted with cold (2 to 8°C) water for injection and diluted in cold sodium chloride 0.9% in bags composed of polyethylene, polyamide, and polypropylene (Baxter Viaflo) to a final concentration of 0.334 mg/mL, the drug was stable with no loss in 48 hours at 2 to 8°C protected from light.3938; 3939
pH Effects
Maximum stability of decitabine has been reported at a pH of 7.0.3712
Temperature Effects
Decitabine in solution degrades quickly at room temperature.3712
Syringes
Decitabine (Dacogen, Janssen-Cilag) 5 mg/mL reconstituted with cold (2 to 8°C) sterile water for injection and stored in polypropylene syringes (Becton Dickinson) at 2 to 8°C protected from light was stable with no loss of drug in 48 hours.3938; 3939
Freezing Solutions
Decitabine (Dacogen, Janssen-Cilag) 5 mg/mL prepared with cold (2 to 8°C) water for injection and stored in 1-mL polycarbonate syringes with polypropylene plungers (BD) at -25°C was stable for 28 days and exhibited less than 2% loss following thawing at room temperature (25°C) for 5 minutes.3712 No visual changes were observed.3712
For a list of references cited in the text of this monograph, search the monograph titled References.