Amphotericin B liposomal for injection is available as a lyophilized powder in vials containing the equivalent of amphotericin B 50 mg; the vial also contains hydrogenated soy phosphatidylcholine 213 mg, cholesterol 52 mg, distearoylphosphatidylglycerol 84 mg, and alpha tocopherol 0.64 mg, which form the liposomal membrane.3068 Amphotericin B is intercalated into the liposomal membrane to form liposomes that are less than 100 nm in diameter.3068 The vial also contains sucrose 900 mg and disodium succinate hexahydrate 27 mg.3068
Vials should be reconstituted only with 12 mL of sterile water for injection.3068 No other diluent should be used because of potential drug precipitation.3068 After addition of the sterile water for injection, vials should be shaken vigorously for 30 seconds to yield a liposomal suspension concentrate of amphotericin B 4 mg/mL.3068 The vial should be visually inspected for particulate matter and shaken until completely dispersed.3068
To prepare for administration, the volume of reconstituted concentrate used to prepare the dose should be passed through the provided disposable 5-µm filters into an appropriate volume of dextrose 5%, using 1 filter per vial.3068 The final concentration of the drug diluted for infusion generally should be 1 to 2 mg/mL, although lower concentrations of 0.2 to 0.5 mg/mL may be used for infants and small children.3068
Although other amphotericin B products exist, they are sufficiently different from amphotericin B liposomal that extrapolating information to or from other forms is inappropriate.3068
pH
From 5 to 6.3068
Trade Name(s)
AmBisome
Amphotericin B liposomal is administered by intravenous infusion following dilution in dextrose 5% using a controlled infusion device over approximately 120 minutes.3068 The administration time may be reduced to 60 minutes for patients who tolerate the infusion well.3068 If an existing line is used to administer amphotericin B liposomal, the line should be flushed with dextrose 5% prior to administration, otherwise a separate line must be used.3068 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 liposomal for injection are stored at room temperatures up to 25°C.3068 The reconstituted concentrate is a yellow, translucent suspension.3068
The manufacturer states that the reconstituted concentrate may be stored at 2 to 8°C for up to 24 hours.3068 The reconstituted concentrate should be protected from freezing.3068 Vials contain no preservative; partially used vials should be discarded.3068 The manufacturer also has confirmed that amphotericin B liposomal at a concentration of 4 mg/mL in sterile water for injection in the original glass vial is stable for 14 days at 2 to 8°C and protected from light.3069
The manufacturer states that administration of amphotericin B liposomal should begin within 6 hours of dilution in dextrose 5%.3068 However, the manufacturer also has indicated that the drug diluted in dextrose 5% for administration is stable for longer time periods.3069 (See Solution Compatibility.)
The manufacturer states that amphotericin B liposomal should not be mixed with saline or solutions containing bacteriostatic agents.3068
Syringes
The manufacturer states that amphotericin B liposomal 4 mg/mL packaged in syringes is stable for 14 days stored at 2 to 8°C and protected from light.3069
Filtration
The volume of reconstituted concentrate of amphotericin B liposomal used to prepare the dose should be passed through the disposable 5-µm filter (provided with each vial of drug) into an appropriate volume of dextrose 5% for dilution, using 1 filter per vial.3068
The manufacturer states that amphotericin B liposomal diluted for infusion may be administered through an inline filter as long as the mean pore diameter of the filter is not smaller than 1 µm.3068
For a list of references cited in the text of this monograph, search the monograph titled References.