Azacitidine Infusion Preparation
Reconstitution for Intravenous Administration
Reconstitute azacitidine aseptically by injecting 10 mL of Sterile Water for Injection, USP slowly into each 100 mg vial to achieve a final concentration of 10 mg/mL; vigorously shake or roll the vial until a uniform solution is achieved. 1
The reconstituted solution should be clear and free of particulate matter; inspect visually before proceeding and discard if particulate matter or discoloration is present. 1
Each vial is single-dose and contains no preservatives; discard any unused portion immediately after withdrawing the required dose. 1
Dilution for Intravenous Infusion
Withdraw the calculated dose from the reconstituted vial(s) and inject into a 50–100 mL infusion bag containing 0.9% Sodium Chloride Injection or Lactated Ringer's Injection. 1
Do not use 5% Dextrose Injection as the diluent, because azacitidine degrades much faster in dextrose solutions (t90 = 0.8 hours) compared to normal saline or lactated Ringer's (t90 ≈ 2 hours). 2
Stability and Storage After Reconstitution
If reconstituted with room-temperature diluent, administer the infusion within 1 hour; if reconstituted with cold (2–8°C) diluent, the solution may be refrigerated at 2–8°C for up to 8 hours before administration. 1
Azacitidine degradation is highly temperature-sensitive: at room temperature (23°C), 15% of the drug is lost after 9.6 hours; at 4°C, 32% is lost after 4 days. 3
Do not freeze reconstituted azacitidine solutions intended for intravenous use; freezing is only validated for subcutaneous suspensions. 1, 3
Administration Technique
Infuse the diluted azacitidine solution intravenously over 10–40 minutes. 1
Use standard IV tubing and do not use an in-line filter, as filtration may remove active drug. 1
Aseptic Technique and Hazardous Drug Handling
Azacitidine is a hazardous drug; prepare under a biological safety cabinet or compounding aseptic containment isolator using closed-system transfer devices, double chemotherapy gloves, and a protective gown. 1
Follow institutional hazardous drug handling and disposal procedures throughout preparation and administration. 1
Common Preparation Pitfalls
Never prepare azacitidine infusions in advance for later use beyond the validated stability window (1 hour at room temperature or 8 hours refrigerated), as significant drug degradation will occur. 3, 2
Do not attempt to salvage unused portions from opened vials; the lack of preservative makes multi-dose use unsafe. 1
Avoid using 5% dextrose as a diluent, which accelerates azacitidine hydrolysis and reduces the effective dose delivered to the patient. 2