VYXEOS is indicated for the treatment of adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes.
VYXEOS has different dosage recommendations than other daunorubicin and cytarabine-containing products. Do not interchange with products containing these ingredients.
Do not use in patients with a history of serious hypersensitivity reactions to cytarabine, daunorubicin or any other components of VYXEOS.
((Jamie Lee, PharmD))
The administration schedule for VYXEOS is different than the traditional 7+3 regimen and allows for less infusion time.
For the first cycle, VYXEOS induction is administered on Days 1, 3, and 5 for 90 minutes and consolidation is administered on Days 1 and 3 for 90 minutes.
A full course of VYXEOS treatment consists of up to 2 cycles of induction and up to 2 cycles of consolidation.
In the Phase 3 trial, most patients received induction with VYXEOS in the inpatient setting.
Fifty-one percent of patients received consolidation in the outpatient setting.
In my institution we have experience administering Vyxeos outpatient for induction and consolidation.
Serious or fatal hemorrhage including CNS hemorrhage have occurred with VYXEOS. Monitor blood counts regularly and provide platelet transfusions as needed.
Due to the risk of cardiotoxicity, VYXEOS is not recommended in patients with impaired cardiac function. Discontinue in patients with impaired cardiac function unless the benefit of treatment outweighs the risk. Calculate the lifetime cumulative anthracycline exposure prior to each cycle of VYXEOS.
Discontinue in patients with severe or life-threatening hypersensitivity reactions, treat the signs and symptoms and monitor until resolution.
Use only if the benefit outweighs the risks in patients with Wilson’s disease or other copper-related metabolic disorders. Discontinue in patients who develop acute copper toxicity.
Administer by the intravenous route only.
Advise females and males of the potential for VYXEOS to cause fetal harm and to use effective contraception.
The most common adverse reactions include hemorrhagic 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.
VYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
IMPORTANT SAFETY INFORMATION
AML=acute myeloid leukemia.