Parenteral Manual

Amphotericin B Liposomal

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): 
AMBISONE
Classification: 
Antifungal
Original Date: 
January 2009
Revised Date: 
December 2011
Indications: 
  • Treatment of severe systemic/deep mycoses in patients who:
    - fail to respond to conventional amphotericin B (continuous fungemia or positive fungal cultures after a minimum trial of 10 days)
    - develop nephrotoxicity after conventional amphotericin B (doubling of serum creatinine from baseline or a daily jump in serum creatinine of 30-50 mmol/L)
    - have conventional amphotericin B  contraindicated because of renal impairment (creatinine clearance less than 60 mL/min/1.73m2

- RESTRICTED TO INFECTIOUS DISEASE / ONCOLOGY

Reconstitution and Stability: 
VIAL SIZE STERILE WATER for INJECTION REQUIRED FINAL CONCENTRATION
50 mg 12 mL                    -shake vigorously 30 seconds 4 mg/mL
  • Filter through a 5 micron filter prior to dilution -use 1 filter for each vial of drug
  • Protect from light
  • Reconstituted vial stable 24 hours refrigerated
  • Diluted in D5W to 0.2 mg/mL stable 11 days refrigerated, 24 hours at room temperature
  • Diluted in D5W to 2 mg/mL stable 14 days refrigerated, 24 hours at room temperature
Compatibility: 

-Solutions Compatible:  Dextrose solution up to D25W

-DO NOT mix with other drugs

-Incompatible:  saline solutions

Administration: 

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

SC NO
IM NO
IV Direct NO
IV Intermittent Infusion

YES
Syringe pump: 2 mg/mL ONLY

Large volume pump: Usual dilution:  0.2-2 mg/mL
Don’t use a minibag smaller than 50 mL
Infusion time:  over 1 - 2 hours

IV Continuous Infusion NO
Dosage: 

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

Adult / Pediatric (greater than 1 month):

  • Initial:  3 - 5 mg/kg/day
  • Doses of 10 mg/kg/day have been use in patients with documented Apergillus infection
Potential hazards of parenteral administration: 
  • Less toxic than conventional amphotericin B
  • Transient decreases in renal function:  hypokalemia, nephrotoxicity (azotemia, increased serum creatinine, renal tubular acidosis)
  • Diarrhea, nausea, vomiting
  • Arrhythmias
  • Anaphylaxis
  • CNS:  headache, dizziness, fever/chills
  • Elevated liver enzymes (AST, ALT, alkaline phosphatase)
Notes: 
  • Monitor hepatic and renal function tests, CBC, electrolytes (especially magnesium and potassium)
  • Dose adjustment may be required with renal dysfunction
  • DO NOT administer through a line with an in-line filter less than 1 micron 
  • Flush line with D5W prior to infusion
  • Consider sodium loading to minimize the nephrotoxic risk
    - Patient must be euvolemic with a normal serum sodium
    - Contraindication - significant cardiac, renal or respiratory compromise
    - Procedure - infuse sodium chloride 0.9% 10 mL/kg (1.5 mmol Na/Kg) IV over 60 minutes prior to Amphotericin B Liposomal infusions
    - Flush IV lines with dextrose solution prior to administration of Amphotericin B Liposomal due to incompatibility with saline containing solutions
    - Continue sodium loading for the duration of Amphotericin B Liposomal therapy
References: 

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