Doxorubicin hydrochloride liposomal is available as a liposomal dispersion concentrate for injection providing 2 mg/mL of doxorubicin hydrochloride packaged in vials containing 20 or 50 mg of doxorubicin hydrochloride.3987
Over 90% of the doxorubicin hydrochloride is encapsulated inside pegylated liposome carriers composed of N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine, 9.58 mg/mL; and cholesterol, 3.19 mg/mL.3987 Each mL also contains ammonium sulfate approximately 0.6 mg, histidine as a buffer, hydrochloric acid and/or sodium hydroxide to adjust pH, and sucrose to adjust tonicity.3987
The liposomal dispersion concentrate for injection must be diluted prior to administration.3987
CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs. The manufacturer states that doxorubicin hydrochloride liposomal must not be substituted for other drugs containing doxorubicin hydrochloride.3987
Equivalency
Doxorubicin hydrochloride 2 mg is equivalent to 1.87 mg doxorubicin.3987
pH
The liposomal dispersion concentrate has a pH of 6.5.3987
Trade Name(s)
Doxil
Doxorubicin hydrochloride liposomal is administered intravenously after dilution in dextrose 5%.3987 Doses of 90 mg or less should be diluted in 250 mL, while doses exceeding 90 mg should be diluted in 500 mL of dextrose 5%.3987 The product should not be administered undiluted or as a bolus injection.3987
CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.
Doxorubicin hydrochloride liposomal concentrate for injection is a red translucent liposomal dispersion.3987 Intact vials of doxorubicin hydrochloride liposomal should be stored under refrigeration at 2 to 8°C.3987 Do not freeze.3987 Diluted solutions should be stored at 2 to 8°C and administered within 24 hours after preparation.3987
Doxorubicin hydrochloride liposomal 0.15 mg/mL in dextrose 5% did not result in the loss of viability of Staphylococcus aureus, Enterococcus faecium, Pseudomonas aeruginosa, and Candida albicans within 120 hours at 22°C. Diluted solutions should be stored under refrigeration whenever possible, and the potential for microbiological growth should be considered when assigning expiration periods.2740
Filtration
Inline filters should not be used for administration of doxorubicin hydrochloride liposomal.3987
For a list of references cited in the text of this monograph, search the monograph titled References.