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.
((Sara M. Tinsley, Ph.D., ARNP, AOCN))
It's important that patients are deemed clinically stable in order to use an IPOP approach.
A patient’s age should be considered, but age alone should not determine the treatment approach.
A patient’s proximity and their ability to get to an infusion center quickly are important.
The facility needs to have ample infusion chairs and availability to accommodate patients for a number of hours.
In addition to the patient coming in on Days 1, 3, and 5 for the 90-minute VYXEOS infusion during their first induction cycle, they typically will need to be at the outpatient clinic every day for a physical exam and blood transfusions, if needed.
During the exam, medications are reviewed and blood work is assessed to determine if platelet or red blood cell transfusions are needed.
The patient is checked for fever and asked about any new symptoms.
It is important to explain to the patient and caregiver that outpatient treatment likely means a half-day at the infusion center for blood collection, labs, and lab results.
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