Liposome-encapsulated combination of daunorubicin-cytarabine for adults with some types of poor prognosis AML.
Trade name Vyxeos.
For the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.
Approval was based on data from Study CLTR0310-301a randomized (1:1), multicenter, open-label, active-controlled trial comparing Vyxeos to a standard combination of daunorubicin and cytarabine (7+3) in 309 patients 60-75 years of age with newly-diagnosed t-AML or AML-MRC.
The drug demonstrated an estimated median overall survival of 9.6 months compared with 5.9 months for the 7+3 control.
The most common adverse reactions occurring in greater than 25% of patients; were hemorrhage events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders and vomiting.
Each Vyxeos vial contains 44 mg daunorubicin and 100 mg cytarabine encapsulated together in liposomes.
Each dose is calculated based on the daunorubicin dose (mg/m2) using body surface area.
For the first induction cycle, the recommended dose is (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome via intravenous infusion over 90 minutes on days 1, 3, and 5.
If needed, the same dose is administered on days 1 and 3 of second induction. The recommended dose for each cycle of consolidation therapy is (daunorubicin 29 mg/m2 and cytarabine 65 mg/m2) liposome via intravenous infusion over 90 minutes on days 1 and 3.