Cytarabine/​Daunorubicin

DEA Class; Rx

Common Brand Names; Vyxeos

Liposomal combination of daunorubicin (an anthracycline topoisomerase inhibitor) and cytarabine (a nucleoside metabolic inhibitor)
Used for newly diagnosed therapy-related AML or AML with myelodysplasia-related changes in adults and pediatric patients aged 1 year and older
Severe bleeding events and hypersensitivity reactions have been reported

Serious hypersensitivity to daunorubicin, cytarabine, or any component of the formulation

• Hemorrhage, all grades (70%)
• Febrile neutropenia, all grades (68%)
• Febrile neutropenia, ≥grade 3 (66%)
• Rash, all grades (54%)
• Edema, all grades (51%)
• Nausea, all grades (47%)
• Diarrhea/colitis, all grades (45%)
• Abdominal pain, all grades (33%)
• Cough, all grades (33%)
• Headache, all grades (33%)
• Dyspnea, all grades (32%)
• Fatigue, all grades (32%)
• Arrhythmia, all grades (30%)
• Decreased appetite, all grades (29%)
• Prolonged thrombocytopenia, induction (28%)
• Pneumonia (excluding fungal), all grades (26%)
• Sleep disorders, all grades (25%)
• Prolonged thrombocytopenia, consolidation cycle (25%)
• Bacteremia (excluding sepsis), all grades (24%)
• Vomiting, all grades (24%)
• Chills, all grades (23%)

Do not interchange with other daunorubicin- and/or cytarabine- containing products

Serious or fatal hemorrhage events may occur; monitor blood cell counts until recovery and administer platelet transfusion if needed

Reports of fatal hypersensitivity reactions (eg, anaphylactic reactions); monitor for hypersensitivity reactions

Severe local tissue necrosis at extravasation site has been associated with daunorubicin; confirm patency of intravenous access before administration; administer IV only; do not administer IM or SC

May cause embryofetal harm

There are no adequate and well-controlled studies of Vyxeos, daunorubicin, or cytarabine in pregnant females

There are no data on drug presence or its metabolites in human milk, effects on breastfed infants, or effects on milk production