Daunorubicin and Cytarabine Combination Product

The combination product, Vyxeos® (daunorubicin and cytarabine), is now listed on the Pharmaceutical Benefits Scheme (PBS). It is indicated for the treatment of acute myeloid leukaemia (AML), specifically newly diagnosed therapy-related AML and AML with myelodysplasia-related changes.

Vyxeos® is a liposomal formulation containing daunorubicin and cytarabine in a 1:5 molar ratio. This formulation provides an extended duration of effect compared to conventional daunorubicin and cytarabine. In a Phase 3 study, Vyxeos® was associated with improved clinical outcomes. The median overall survival was 9.56 months for Vyxeos® compared to 5.95 months for conventional therapy, and the overall remission rate was 47.7% compared to 33.3%. The incidence and severity of adverse effects were similar for each group.

Vyxeos® should be used with caution in patients with Wilson’s disease or other disorders of copper metabolism. Copper gluconate is added to this formulation to ensure stable encapsulation of daunorubicin within the liposome. The International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) recommends a permitted daily exposure (PDE) of 340 micrograms for parenterally administered copper. While each Vyxeos® vial contains 14mg of elemental copper, the number of lifetime doses is limited and pharmacokinetic data indicates that the copper is released slowly from the liposomes. Therapy should be discontinued in patients who exhibit signs or symptoms of acute copper toxicity.

Vyxeos® is not interchangeable with other daunorubicin and cytarabine products. The product information should be consulted for the recommended dosing schedule.