Parenteral Manual

AzaCITIDine (NON-FORMULARY)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
VIDAZA, 5-Azacytidine, U-18496, 5-AZC
Classification: 
Antineoplastic, Pyrimidine analogue - CYTOTOXIC
Original Date: 
December 2010
Revised Date: 
July 2017
Indications: 
  • Myelodysplastic Syndrome  (MDS)
  • Acute Myeloid Leukemia  (AML)
  • Infant Acute Lymphoblastic Leukemia (ALL)

THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.

Reconstitution and Stability: 

Commercial Supply for Subcutaneous administration:

  • Available as a 100 mg vial of lyophilized powder for reconstitution.  Single use vials.
  • Reconstitute vial with 4 mL of sterile water for injection to yield a 25 mg/mL solution.  Shake vial vigorously until a uniform cloudy suspension is achieved.  The reconstituted solution should be a homogenous, cloudy suspension free of agglomerates
  • Dose must be administered within 45 minutes of preparation
  • Store unopened vials at room temperature
  • Reconstituted solution is stable for 45 minutes at room temperature and 8 hours in the refrigerator (2°C to 8°C)
  • If stored in refrigerator, give within 30 minutes of removing from fridge
  • Re-suspend syringe contents immediately before injection by inverting syringe several times and rolling between palms of hands for approximately 30 seconds

 

Study Supply and Commercial Supply for Intravenous administration:

  • Provided as a 100 mg vial of lyophilized powder for reconstitution. Single use vials.
  • Reconstitute vial with 10 mL sterile water for injection to yield a 10 mg/mL solution
  • Vigorously shake or roll vial until solution is dissolved and clear
  • Further dilute in 0.9% NaCl or lactated Ringer’s injection to a final concentration of 0.9-4 mg/mL
  • Dose administration must be completed within 45 minutes of reconstitution. Only prepare doses immediately prior to administration.
  • Store unopened vials at room temperature
Compatibility: 

- Solutions compatible - 0.9% NaCl or Ringer's Lactate only

- Incompatible - Dextrose

DO NOT mix with other solutions or drugs.

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC YES - into the upper arm, thigh or abdomen; doses greater then 4 mL should be injected into two separate sites; patient size and subcutaneous tissue amount should be considered for determining the injection volume per site for children; rotate the sites of injection.  Do not use insuflon.
IM NO
IV Push NO
IV Intermittent Infusion YES
Infusion time: 10 - 40 minutes
Flush with 0.9% NaCl only
IV Continuous Infusion NO

 

 

Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

MDS/AML (Adult data) :

  • 75 mg/m2 subcutaneously once daily for 7 consecutive days, repeat every 28 days
  • 75 mg/m2 IV once daily for 7 consecutive days

 

Pediatric ALL:

  • 2.5 mg/kg IV once daily x 5 days
Potential hazards of parenteral administration: 

Immediate (within a few minutes to hours):

  • Hypersensitivity reaction (fever/rash) -rare
  • Local reaction at the injection site
  • Nausea and vomiting (moderately emetogenic)

Delayed (within a few days or weeks):

  • Nausea, vomiting, diarrhea/constipation
  • Anorexia
  • Fever
  • Fatigue
  • Myelosuppression, nadir 15 - 16 days
  • Arthralgia, myalgia
Notes: 
  • NON-VESICANT
  • Contraindicated in the presence of advanced malignant hepatic tumors
  • Use in caution in patients with renal dysfunction as azacitidine and its metabolites are primarily renally excreted
  • Use in caution in patients with severe CHF, clinically unstable heart or lung disease
References: 

Azacitidine (Vidaza) for injection product monograph. Celgene Inc. Mississauga Ontario. Version 23 November 2016

Lexicomp Online, Pediatric and Neonatal Lexi-Drugs Online, Hudson, Ohio: Lexi-Comp, Inc.; 2017; 25 July 2017. Azacitidine

Children’s Oncology Group AALL15P1. A groupwide pilot study to test the tolerability and biologic activity of the addition of azacitidine (IND#133688, NSC#102816) to chemotherapy in infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement. Version date: 03/17/17

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