Amphotericin B lipid complex is available in single-use 20-mL vials containing amphotericin B complexed with 2 phospholipids in a 1:1 drug to lipid molar ratio; the injection is an opaque, yellow suspension.3072 Each mL of the suspension contains amphotericin B 5 mg, L-a-dimyristoylphosphatidylcholine (DMPC) 3.4 mg, L-a-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg, and sodium chloride 9 mg in water for injection.3072
To prepare the infusion, each vial should first be gently shaken until no yellow sediment is visible on the bottom of the vial.3072 The appropriate dose should be withdrawn from the necessary number of vials using 1 or more syringes equipped with 18-gauge needles.3072 The 18-gauge needle should then be removed from the syringe and replaced with the 5-µm filter needle that is supplied with each vial of the drug, and the drug suspension should be transferred into an infusion bag of dextrose 5%.3072 One filter needle may be used to filter up to 4 vials of the drug.3072 The final concentration of the drug diluted for infusion should be 1 mg/mL, although more concentrated infusions of 2 mg/mL may be used in some cases (e.g., pediatric patients, patients with cardiovascular disease).3072
Although other amphotericin B products exist, they are sufficiently different from amphotericin B lipid complex that extrapolating information to or from other forms is inappropriate.3072
pH
5 to 7.3072
Trade Name(s)
Abelcet
Amphotericin B lipid complex diluted to a concentration of 1 or 2 mg/mL in dextrose 5% is administered by intravenous infusion at a rate of 2.5 mg/kg/hr.3072 The infusion bag should be shaken just prior to administration until the contents are thoroughly mixed.3072 The admixture should not be used if evidence of foreign matter is present.3072 If the infusion time exceeds 2 hours, the infusion bag should be shaken every 2 hours to mix the remaining contents.3072 If an existing line is used to administer amphotericin B lipid complex, the line should be flushed with dextrose 5% prior to administration, otherwise a separate line should be used.3072 CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedure are used and that no confusion with other products occurs.
Intact vials of amphotericin B lipid complex are stored at 2 to 8°C.3072 Vials should be kept in the original carton until time of use to protect from light and should not be frozen.3072
The manufacturer states that amphotericin B lipid complex diluted in dextrose 5% for administration may be stored for up to 48 hours at 2 to 8°C with an additional 6 hours at room temperature.3072 The manufacturer also has confirmed that limited stability studies indicate that amphotericin B lipid complex 1 mg/mL in dextrose 5% is stable for up to 10 days stored at room temperature.3074
Amphotericin B lipid complex should not be mixed with saline or other electrolyte solutions.3072
Freezing Solutions
Admixtures of amphotericin B lipid complex in dextrose 5% should not be frozen.3072
Filtration
The manufacturer states that amphotericin B lipid complex is to be prepared using the 5-µm filter needle provided with the drug; however, the admixture should not be administered using an inline filter.3072 Each 5-µm filter needle provided with the drug may be used to filter up to 4 vials of the drug.3072
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Peritoneal Dialysis Solutions
Amphotericin B lipid complex (Abelcet, The Liposome Company) was evaluated for stability in Dianeal PD-1 with dextrose 1.5% (Baxter) and Dianeal PD-1 with dextrose 4.25% (Baxter) at concentrations of 0.5 mg/L, 2 mg/L, and 10 mg/L, with bags of each concentration stored at 4, 25, and 37°C.3073 Although no visual changes were observed throughout the study period, results of the nuclear magnetic resonance (NMR) spectroscopy analysis demonstrated important changes in the resonances associated with the lipid component of the formulation, suggesting decomposition of the lipid component of the drug and/or bag adherence.3073
For a list of references cited in the text of this monograph, search the monograph titled References.