Parenteral Manual

Amphotericin B Lipid Complex (NON-FORMULARY)

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Alternate Name(s): 
ABELCET, ABLC
Classification: 
Anifungal agent
Original Date: 
August 2005
Revised Date: 
November 2010
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)
  • who develop nephrotoxicity after conventional amphotericin B (doubling of the serum         creatinine from baseline or a daily jump in serum creatinine of 30-50 mmol/L)
  • in whom conventional amphotericin B is contraindicated because of renal impairment        (creatinine clearance < 60 mL/min/1.73m2 )

- RESTRICTED TO INFECTIOUS DISEASES / ONCOLOGY

Reconstitution and Stability: 
  • Available as a 5 mg/mL suspension. Protect from light
  • Allow suspension to come to room temperature.  Shake gently until there is no evidence of yellow settlement at bottom of the vial.  Filter through supplied 5 micron filter needle.
  • Punctured vial stable 2 days refrigerated
  • Diluted solution stable 48 hours refrigerated (plus an extra 6 hours at room temperature)
  • Unpunctured vial stable up to 1 week at room temperature if left out of fridge
Compatibility: 

- Solutions Compatible:  D5W

- Incompatible: saline solutions, ringers lactate, ciprofloxacin, gentamicin, meropenem, penicillin, fluconazole, granisetron, piperacillin.  Do not mix with other drugs or electrolytes (compatibility with these materials has not been established)

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 dilution: 1 mg/mL ONLY

 

Large volume pump

Usual dilution: 1 mg/mL
Fluid restricted patients: 2 mg/mL

Infusion time: 2 -4 hours (if > 2 hours, mix contents by gently rotating the infusion bag every 2 hours)

Infusion rate:  do not exceed 2.5 mg/kg/hour

IV Continuous Infusion NO
Dosage: 

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

Pediatrics

  • 2.5 - 5 mg/kg IV once daily

Adults

  • 5 mg/kg/ IV once daily

DOSING ADJUSTMENT IN RENAL IMPAIRMENT:
It has been suggested that:

  • If CrCl is < 10 mL/min administer dose over 24-36 hours
  • Renal toxicity is dose-dependent.  There are no firm guidelines for dose adjustment based on serum creatinine levels.
Potential hazards of parenteral administration: 
  • Injection site - inflammation, thrombophlebitis
  • Flushing, hypotension
  • Transient chills and fever during infusion
  • Rash, pruritus, other allergic reactions, anaphylactoid reactions
  • Renal tubular acidosis, increased serum creatinine
  • Hypokalemia, hypomagnesemia, thrombocytopenia, leukopenia
  • Nausea, vomiting, headache
Notes: 
  • Monitor BUN, serum creatinine, liver function tests, serum electrolytes, CBC, ins and outs, signs of hypokalemia (muscle weakness, cramping, drowsiness, EKG changes)
  • Monitor vital signs throughout infusion
  • Premedication with acetaminophen and diphenhydramine may help reduce severity of side effects.
  • 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 caridac, 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 Lipid Complex infusions
    - Flush IV lines with dextrose solution prior to administration of Amphotericin B Lipid Complex due to incompatibility with saline containing solutions
    - Continue sodium loading for the duration of Amphotericin B Lipid Complex therapy
References: 

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