Rethink the potential of your sAML patients
The Best Chance at a Cure1,2
VYXEOS delivers on key treatment milestones better than 7+3, with significantly longer OS, better remission rates, and improved opportunity for HSCT.1-3
Efficacy for sAML
The only preferred option for patients aged ≥60 years fit for IC4
Choose a treatment that can lead to remission and prolonged OS.1
Mechanism of action
Gain greater control over drug delivery
VYXEOS was developed to simultaneously deliver a synergistic combination of daunorubicin and cytarabine that persists in the bone marrow.1
Dosing and Administration
Offer your patients a finite treatment duration
Treatment with VYXEOS gives your patients additional flexibility between induction and consolidation cycles, and some patients may have the opportunity for outpatient administration.1,5
HSCT=hematopoietic stem-cell transplantation; IC=intensive chemotherapy; MOA=mechanism of action; OS=overall survival; sAML=secondary acute myeloid leukemia.
Safety
The safety profile of VYXEOS in the Phase 3 study was comparable with 7+3, with similar types and severity of adverse reactions.3
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Videos
Easy-to-watch videos are available on a range of topics, including sAML, VYXEOS clinical data, dosing and administration, and real patient stories.
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Support
Comprehensive support is available for you, your office staff, and your patients. Check out downloadable resources, find VYXEOS publications, and learn about the patient support program JazzCares.
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INDICATION 
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
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. Lancet JE, Uy GL, Newell LF, et al. CPX-351 versus 7+3 cytarabine and daunorubicin chemotherapy in older adults with newly diagnosed high-risk or secondary acute myeloid leukaemia: 5-year results of a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2021;8(7):e481-e491.
3. Lancet JE, Uy GL, Cortes JE, et al. CPX-351 (cytarabine and daunorubicin) liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary acute myeloid leukemia. J Clin Oncol.
2018;36(26):2684-2692.
4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed April 3, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
5. 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.
