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.
((Rami Komrokji, MD))
The difference between de novo AML and secondary AML is that de novo AML is AML in a patient with no prior history of antecedent hematological disease, while secondary AML is used to describe both AML from specific genetic mutations or antecedent blood disorders, such as MDS or MDS/MPN, and therapy-related AML.
AML-MRC is defined as greater than or equal to 20% blasts in the peripheral blood or bone marrow, along with previously documented MDS or MDS/MPN, myelodysplasia-related cytogenetic abnormalities, or dysplasia present in 50% or more of the cells in at least 2 cell lines, unless an NPM1 mutation or biallelic mutation of CEBPA is present.
t-AML occurs after medical treatments such as radiation, immunosuppressive therapies, or chemotherapies.
AML is generally a disease of older people with an average age of onset of 68 years.
It is important to differentiate de novo AML from sAML because outcomes for patients with secondary AML are much worse and these patients need more consideration to get to transplant.
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.