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Transcript

((Voice Over))
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))

Some larger institutions are conducting IPOP administration more frequently, but there are some elements to consider before proceeding with this treatment plan, such as patient- and disease-related factors and the institution’s infrastructure.

It is important to assess whether the patient's disease is in proliferative status or they have neutropenia or any other major comorbidities, as these factors would likely remove them as candidates for IPOP administration.

In addition, for our institution, patients with renal failure are typically excluded from IPOP treatment with VYXEOS.

Another consideration for IPOP is that the patient should be able to stay local for induction on Days 1, 3, and 5 of treatment prior to planned admission.

The institution must also have the necessary infrastructure to support an IPOP approach, which may include daily monitoring and transfusion support, with blood transfusions given as needed.

Daily monitoring may include clinical evaluation and blood tests, such as complete blood count, comprehensive metabolic panel, and uric acid and phosphorus levels.

Typically, patients will spend a half day in the infusion center and be given fluids for hydration and other supportive treatments as needed.

((Voice Over))
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.

INDICATION

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

INDICATION

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

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors.