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Dosing Schedule Outpatient Strategies Preparation & Administration
Dosing Schedule

VYXEOS provides a finite treatment duration1

Treatment with VYXEOS gives your patients additional flexibility between induction and consolidation cycles.

Administration Schedule Video icon
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Dosing

VYXEOS is administered through up to 2 cycles of
induction and consolidation1

First induction

Days 1, 3, and 5
Daunorubicin 44 mg/m2
and cytarabine 100mg/m2

First induction First induction

Second induction (if needed)
Daunorubicin 44 mg/m2 and cytarabine
100 mg/m2 liposome on Days 1 and 3

For patients who do not achieve remission after first induction, a second induction
may be started 2 to 5 weeks later at the same dose on Days 1 and 3.

CONSOLIDATION

Patients could receive consolidation or proceed to HSCT.

Days 1 and 3
Daunorubicin 29 mg/m2
and cytarabine 65 mg/m2

Consolidation Consolidation

Second consolidation (if needed)

Daunorubicin 29 mg/m2 and cytarabine
65 mg/m2 liposome on Days 1 and 3

  • 5 to 8 weeks after the start of first consolidation in patients who do not show disease progression or unacceptable toxicity

Of the 49 patients who received first consolidation with VYXEOS, 51% (n=25)
received consolidation in an outpatient setting during the Phase 3 study2

Dosing CONSIDERATIONS

Consider patient fitness before beginning treatment1

  • Prior to initiating each cycle, calculate the prior cumulative anthracycline exposure for the patient
  • Assess cardiac function, complete blood counts, and liver and renal function before each consolidation cycle
  • Do not start consolidation until the absolute neutrophil count (ANC) recovers to >0.5 Gi/L and the platelet count recovers to
    >50 Gi/L in the absence of unacceptable toxicity
  • In the Phase 3 study, VYXEOS was evaluated in patients aged
    60-75 years
Calculate VYXEOS Dosing
Dosing CONSIDERATIONS Image

Outpatient Strategies

Some patients may be appropriate for outpatient administration of VYXEOS, giving you more options when planning their treatment. Read how some institutions are approaching outpatient use of VYXEOS.

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Preparation & Administration

VYXEOS is prepared for infusion through straightforward steps.1
See our helpful guides on how to prepare and administer VYXEOS.

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INDICATION Close

VYXEOS is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t‑AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

Important Safety Information Open Close

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.

Contraindications

VYXEOS is contraindicated in patients with a history of serious hypersensitivity reactions to cytarabine, daunorubicin, or any component of the formulation.

Warnings and Precautions
Hemorrhage

Serious or fatal hemorrhage events, including fatal CNS hemorrhages, associated with prolonged thrombocytopenia, have occurred with VYXEOS. The overall incidence (grade 1-5) of hemorrhagic events was 74% in the VYXEOS arm and 56% in the control arm. The most frequently reported hemorrhagic event was epistaxis (36% in VYXEOS arm and 18% in control arm). Grade 3 or greater events occurred in 12% of VYXEOS-treated patients and in 8% of patients in the control arm. Fatal treatment-emergent CNS hemorrhage not in the setting of progressive disease occurred in 2% of patients in the VYXEOS arm and in 0.7% of patients in the control arm. Monitor blood counts regularly and administer platelet transfusion support as required.

Cardiotoxicity

VYXEOS contains daunorubicin, which has a known risk of cardiotoxicity. This risk may be increased in patients with prior anthracycline therapy, preexisting cardiac disease, previous radiotherapy to the mediastinum, or concomitant use of cardiotoxic drugs. Assess cardiac function prior to VYXEOS treatment and repeat prior to consolidation and as clinically required. Discontinue VYXEOS in patients with impaired cardiac function unless the benefit of initiating or continuing treatment outweighs the risk. VYXEOS is not recommended in patients with cardiac function that is less than normal.

Total cumulative doses of non-liposomal daunorubicin greater than 550 mg/m2 have been associated with an increased incidence of drug-induced congestive heart failure. The tolerable limit appears lower
(400 mg/m2) in patients who received radiation therapy to the mediastinum. Calculate the lifetime cumulative anthracycline exposure prior to each cycle of VYXEOS. VYXEOS is not recommended in patients whose lifetime anthracycline exposure has reached the maximum cumulative limit.

Hypersensitivity Reactions

Serious or fatal hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine. Monitor patients for hypersensitivity reactions. If a mild or moderate hypersensitivity reaction occurs, interrupt or slow the rate of infusion with VYXEOS and manage symptoms. If a severe or life-threatening hypersensitivity reaction occurs, discontinue VYXEOS permanently, treat the symptoms, and monitor until symptoms resolve.

Copper Overload

VYXEOS contains copper. Consult with a hepatologist and nephrologist with expertise in managing acute copper toxicity in patients with Wilson’s disease treated with VYXEOS. Monitor total serum copper, serum non-ceruloplasmin-bound copper, 24-hour urine copper levels, and serial neuropsychological examinations during VYXEOS treatment in patients with Wilson’s disease or other copper-related metabolic disorders. Use only if the benefits outweigh the risks. Discontinue in patients with signs or symptoms of acute copper toxicity.

Tissue Necrosis

Daunorubicin has been associated with severe local tissue necrosis at the site of drug extravasation. Administer VYXEOS by the intravenous route only. Confirm patency of intravenous access before administration. Do not administer by intramuscular or subcutaneous route.

Embryo-Fetal Toxicity

VYXEOS can cause embryo-fetal harm when administered to a pregnant woman. Patients should avoid becoming pregnant while taking VYXEOS. If VYXEOS is used during pregnancy or if the patient becomes pregnant while taking VYXEOS, apprise the patient of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of VYXEOS.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions (incidence ≥25%) are hemorrhagic events (74%), febrile neutropenia (70%), rash (56%), edema (55%), nausea (49%), mucositis (48%), diarrhea (48%), constipation (42%), musculoskeletal pain (43%), fatigue (39%), abdominal pain (36%), dyspnea (36%), headache (35%), cough (35%), decreased appetite (33%), arrhythmia (31%), pneumonia (31%), bacteremia (29%), chills (27%), sleep disorders (26%), and vomiting (25%).

Please see full Prescribing Information, including BOXED Warning.

References: 1. VYXEOS [package insert]. Palo Alto, CA: Jazz Pharmaceuticals. 2. Kolitz JE, Strickland SA, Cortes JE, et al. Consolidation outcomes in CPX-351 versus cytarabine/daunorubicin-treated older patients with high-risk/secondary acute myeloid leukemia. Leuk Lymphoma. 2020;61(3):631-640.

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