• Leukemias, lymphomas, and other hematologic cancers

Vyxeos Generic Name & Formulations

General Description

Daunorubicin, cytarabine 44mg/100mg (encapsulated in liposomes); per vial; lyophilized cake for IV infusion after reconstitution and dilution; contains copper; preservative-free.

Pharmacological Class

Anthracycline + antimetabolite.

How Supplied

Single-dose vials—2

Generic Availability


Vyxeos Indications


Newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Vyxeos Dosage and Administration

Adults and Children

<1yr: not established. Calculate the prior cumulative anthracycline exposure before initiating each cycle. Give prophylactic antiemetics. Administer by IV infusion over 90mins. ≥1yr: First induction: Vyxeos (daunorubicin 44mg/m2 and cytarabine 100mg/m2) on Days 1, 3, and 5. Second induction (may give after 2–5 weeks if remission not achieved and no unacceptable toxicity): Vyxeos (daunorubicin 44mg/m2 and cytarabine 100mg/m2) on Days 1 and 3. Consolidation (give 5–8 weeks after last induction): Vyxeos (daunorubicin 29mg/m2 and cytarabine 65mg/m2) on Days 1 and 3. Do not initiate consolidation until ANC recovers to >0.5Gi/L and platelet count >50Gi/L in the absence of unacceptable toxicity. May give second consolidation 5–8 weeks after if no disease progression or unacceptable toxicity.

Vyxeos Contraindications

Not Applicable

Vyxeos Boxed Warnings

Boxed Warning

Do not interchange with other daunorubicin and/or cytarabine-containing products.

Vyxeos Warnings/Precautions


Do not interchange with other daunorubicin and/or cytarabine-containing products. Risk of serious hemorrhagic events (including CNS hemorrhages) with associated prolonged thrombocytopenia; monitor CBCs regularly until recovery. Prior anthracycline therapy, pre-existing cardiac disease, or radiotherapy to mediastinum: increased risk of cardiotoxicity. Assess CBCs, cardiac, liver, and renal function prior to initiation. Discontinue if impaired cardiac function unless benefit outweighs risk. If LVEF below normal or max lifetime cumulative anthracycline exposure limit reached: not recommended. Monitor for hypersensitivity reactions; interrupt and reduce infusion rate if mild or moderate symptoms; permanently discontinue if severe/life-threatening reactions occur. Wilson's disease: use only if benefit outweighs risk. Monitor copper levels and serial neuropsychological exam; discontinue if signs/symptoms of acute copper toxicity develops. Avoid extravasation. Hepatic (bilirubin >3mg/dL) or ESRD on hemodialysis: not studied. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for ≥6 months after the last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).

Vyxeos Pharmacokinetics

See Literature

Vyxeos Interactions


Increased toxicity with concomitant cardiotoxic or hepatotoxic agents; monitor more frequently.

Vyxeos Adverse Reactions

Adverse Reactions

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, vomiting; cardiotoxicity, copper overload, tissue necrosis.

Vyxeos Clinical Trials

See Literature

Vyxeos Note

Not Applicable

Vyxeos Patient Counseling

See Literature