10:00 Antineoplastic Agents
Generic Name
The fixed combination of daunorubicin-cytarabine liposomal is available as a purple, lyophilized cake in single-dose (preservative-free) vials containing 44 mg of daunorubicin and 100 mg of cytarabine encapsulated in liposomes.3369 Each vial also contains distearoyl phosphatidylcholine (DSPC) 454 mg, distearoyl phosphatidylglycerol (DSPG) 132 mg, and cholesterol HP 32 mg, which form the liposomal membrane, as well as copper gluconate 100 mg, triethanolamine 4 mg, and sucrose 2.054 g.3369
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. Although other daunorubicin and cytarabine products exist, they are sufficiently different from daunorubicin-cytarabine liposomal that extrapolating information to or from other formulations or substituting other products is inappropriate.3369
To prepare a diluted solution for infusion, the number of vials of the drug required to achieve the appropriate dose (based on the daunorubicin component) should be allowed to equilibrate to room temperature for 30 minutes.3369 Each vial should then be reconstituted with 19 mL of sterile water for injection.3369 Using a timer set for 5 minutes, each vial should be swirled, gently inverting the vial every 30 seconds.3369 Vials should not be heated, vortexed, or shaken vigorously.3369 Each mL of the resulting reconstituted product contains 2.2 mg of daunorubicin and 5 mg of cytarabine.3369 The reconstituted product should be allowed to rest for 15 minutes.3369 After resting, each vial should be gently inverted 5 times prior to withdrawing the total volume required of the reconstituted product and transferring this volume to an infusion bag containing 500 mL of sodium chloride 0.9% or dextrose 5%.3369 The bag should be gently inverted to mix the solution.3369
Copper Content
The reconstituted daunorubicin-cytarabine product contains copper gluconate 5 mg/mL, 14% of which is elemental copper.3369 Copper gluconate is required for stable daunorubicin encapsulation inside the liposome.1711
Trade Name(s)
Vyxeos
Daunorubicin-cytarabine liposomal should be administered only by the intravenous route; the drug should not be administered by the intramuscular or subcutaneous routes.3369
Diluted solutions of daunorubicin-cytarabine liposomal for infusion should be administered at a constant rate over 90 minutes through a central venous catheter or a peripherally inserted central catheter (PICC) using an infusion pump.3369 The line used to administer the drug should be flushed with sodium chloride 0.9% or dextrose 5% following completion of the infusion.3369 Interruption of the infusion, reduction in the rate of infusion, or discontinuance of the drug may be necessary if hypersensitivity reactions occur; the product labeling should be consulted for additional details on management of hypersensitivity reactions.3369
Severe local necrosis has occurred with extravasation of daunorubicin; care should be taken to avoid extravasation.3369
As with other toxic drugs, applicable special handling and disposal procedures for daunorubicin-cytarabine liposomal should be followed.3369
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.
Intact vials of daunorubicin-cytarabine liposomal for injection should be stored under refrigeration at 2 to 8°C.3369 Vials should be stored upright and in the original carton to protect from light.3369 The reconstituted product is a homogenous opaque purple dispersion essentially free of visible particulates; a homogenous translucent deep purple dispersion free from visible particulates forms upon dilution in sodium chloride 0.9% or dextrose 5%.3369 The solution should be visually inspected for particulate matter and discoloration prior to administration; only solutions without visible particles should be administered.3369
The reconstituted product, if not diluted immediately, is stable for up to 4 hours at 2 to 8°C; the diluted solution for infusion, if not administered immediately following dilution of the reconstituted product, is stable for up to 4 hours at 2 to 8°C.3369 Any unused portion should be discarded.3369
Filtration
Diluted solutions of daunorubicin-cytarabine liposomal for infusion should not be infused through an inline filter.3369
For a list of references cited in the text of this monograph, search the monograph titled References.